On August 27, 2025 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported its 2025 interim results and major business updates (Press release, Innovent Biologics, AUG 27, 2025, View Source [SID1234655531]).

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Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We delivered an outstanding performance in the first half of 2025, driven by the comprehensive acceleration of our dual-engine growth model and global innovation strategy. Supported by our oncology leadership and successful commercial launch across our general biomedicine portfolio, we have expanded our product portfolio to 16 drugs and achieved a notable improvement in revenue and profitability, maintaining strong business momentum.

On the innovation front, several core pipeline candidates with global potential achieved key proof-of-concept data, and are entering global registration trials. This demonstrates the depth of Innovent’s innovation capabilities and lays a solid foundation for globalization.

We firmly believe that a clear strategic vision combined with excellent execution will continue to drive Innovent’s growth. Looking ahead, we will further consolidate our leadership in oncology, continue exploring and implementing diversified commercialization strategies across our general biomedicine product portfolio, and accelerate the global development of our next-generation innovative pipeline. Anchored by our strategic goals of achieving RMB 20 billion in product revenue by 2027 and advancing five pipeline programs into global Phase 3 trials by 2030, Innovent will continue striving to become a world-class biopharmaceutical company."

Dual-driven revenue growth with execution excellence

Robust revenue growth and substantial profit improvement[1]

Total revenue: RMB 5.95 billion, up 50.6% year-on-year
Product revenue: RMB 5.23 billion, up 37.3% year-on-year
Net profit: RMB 1.21 billion; EBITDA: RMB 1.41 billion
Gross margin: 86.8%, up 2.7 percentage points year-on-year
Selling and administrative expenses ratio: 44.2%, down 7.9 percentage points year-on-year
R&D investment: RMB 903 million
Cash on hand: approximately USD 2 billion[2]
Dual-engine growth supported by comprehensive and diversified product portfolio

Expansion of oncology product portfolio with three new launches
Dovbleron (taletrectinib) : Potentially best-in-class ROS1 inhibitor
Limertinib: Third-generation EGFR TKI
Jaypirca(pirtobrutinib) : First non-covalent BTK inhibitor
Strengthening general biomedicine portfolio with innovative pipeline
SINTBILO (tafolecimab injection): First PCSK-9 inhibitor successfully included in the NRDL, received approval by Macau ISAF in May 2025
SYCUME (teprotumumab N01 injection): First approved anti-IGF-1R monoclonal antibody, ending a 70-year drought of no new treatment options for thyroid eye disease (TED) in China
Mazdutide (GCG/GLP-1) : Globally first and only GCG/GLP-1 dual receptor agonist for weight management, with another NDA for glycemic control of T2D adults under NMPA review
Innovative commercial strategy with multi-channel coverage

Actively responding to the national "Year of Weight Management": Participating in the development of the weight-loss industry ecosystem, promoting the concept of scientific weight management, and advancing obesity prevention and chronic disease management
Deepening hospital presence and academic influence: Strengthening academic coverage in public hospitals, with the GLORY-1 study published in The New England Journal of Medicine, significantly enhancing academic influence
Innovative multi-channel coverage: Leveraging a comprehensive sales team of over 1,000 people, integrating public hospitals, retail pharmacies, online medical platforms, and private clinic networks to facilitate convenient access to medications for chronic disease patients
Emphasizing disease education and patient management: Integrating digital tools and professional activities to establish a patient-centric disease management system, enhancing chronic disease education and patient adherence
Enhancing brand strength through the establishment of a lifecycle management system

TYVYT: NDAs for renal and colorectal cancer are under regulatory review; Phase 3 study of neoadjuvant treatment in lung cancer is underway
SYCUME (teprotumumab N01 injection): new Phase 3 studies in plan for inactive TED and head-to-head comparison with steroid therapy in TED
Mazdutide (GCG/GLP-1): second NDA for glycemic control of T2D adults is under regulatory review, alongside with two new Phase 3 studies for obstructive sleep apnea (OSA) and obesity with metabolic dysfunction-associated fatty liver disease (MAFLD, head-to-head with semaglutide 2.4mg). Additional PoC studies are ongoing for adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), etc.
Picankibart (IL-23p19): a potent and long-acting IL-23p19 for moderate-to-severe plaque psoriasis pending NMPA approval; Phase 3 studies are ongoing for treatment withdrawal maintenance and psoriasis with prior inadequate response to IL-17 biologics
Emerging value from globalization strategy, prioritizing novel pipeline’s global R&D

Flagship pipeline showcased at top-tier conferences, entering global registration studies

IBI363 (PD-1/IL-2α-bias): Unleashing potential as a next-generation IO therapy with global first-in-class design
Three oral presentations at ASCO (Free ASCO Whitepaper) highlighted breakthrough PoC data across difficult-to-treat tumors such as IO resistant cold tumors and low PD-L1 expression, demonstrating the unique advantages of dual immune activation and long-term survival benefits
Three pivotal studies are underway or in plan: the first global Phase 3 study is initiating in China and the U.S. to address unmet needs in IO-resistant squamous NSCLC; the first pivotal Phase 2 study in melanoma was initiated, challenging Keytruda in first-line setting; and the first Phase 3 study in late-line colorectal cancer is about to initiate
Continuous exploration in first-line settings and more cancer types, including first-line lung cancer, first-line colorectal cancer, neoadjuvant lung cancer, EGFR-mutated lung cancer, platinum-resistant ovarian cancer, and more
BI343 (CLDN18.2 ADC): two registration trials in GC and PDAC; globally the first ADC to enter a Phase 3 trial in PDAC
First MRCT Phase 3 study of GC has been initiated in China and Japan
First Phase 3 study of PDAC has been initiated
Global MRCT of PDAC is in plan
NMPA CDE Breakthrough Therapy Designation (BTD) and FDA Fast-track Designation (FTD) granted
Over 10 next-generation programs advancing into global development
Oncology: IBI3009 (DLL3 ADC), IBI3001 (EGFR/B7H3 ADC), IBI3003 (GPRC5D/BCMA/CD3), IBI3005 (EGFR/HER3 ADC), IBI3014 (PD-L1/TROP2 ADC), IBI3020 (CEACAM5 dual-payload ADC), etc
CVM: IBI3016 (AGT siRNA), IBI3032 (oral GLP-1), etc
Autoimmune: IBI356 (OX40L), IBI3002 (TSLP/ IL-4Rα), etc
Hybrid models to accelerate innovation

IBI3009 (DLL3 ADC): global rights granted to Roche, to benefit SCLC patients worldwide
Enhance global presence with broader market access

Six products (TYVYT, BYVASDA, Pemazyre, Dupert, SINTBILO, SYCUME) have been launched in markets including Hong Kong, Macau, Taiwan, and Southeast Asia
More launches planned Brazil, Mexico, Columbia, India, etc
Research innovation showcased at medical conferences

Oncology pipeline: AACR (Free AACR Whitepaper), ASCO (Free ASCO Whitepaper), Nature Medicine
General biomedicine pipeline: ADA, NEJM
Facilities and manufacturing capacity adhering to high-quality standards

7,500 employees globally
Global R&D centers located in the San Francisco Bay Area, Shanghai, and Suzhou
To date, Innovent has a total of 140,000L of operational capacity, accounting for 20% of China’s total biopharmaceutical production capacity
First manufacturing site: 60,000L antibody and ADC production capacity in operation, ensuring high-quality supply
Second manufacturing site: first phase of 80,000L antibody production capacity in operation, for global supply and CDMO operations
Committed to responsible business practices and enhancing ESG management practices

Over 3,000 new oncology patients begin treatment with Innovent-developed therapeutics each day, and to date, more than 5 million patients have benefited from Innovent’s innovative drugs
Innovent has been graded ‘AAA’ rating in MSCI ESG rankings, positioning us at the forefront of the biotechnology industry
We have supported over 200,000 patients through our dedicated patient assistance programs, with drug donations totaling RMB 3.6 billion
Our commitment to medical philanthropy has been recognized through prestigious awards, including the "Medical Philanthropy Promoter" title and designation as a "China Philanthropic Enterprise"
Provided over 2,200 job opportunities for recent graduates
To date, Innovent Biologics has contributed more than RMB 6 billion in taxes and fees

On August 27, 2025 Fosun International Limited (HKEX stock code: 00656, "Fosun International"), together with its subsidiaries ("Fosun" or the "Group"), reported its interim results for the six months ended 30 June 2025 (the "Reporting Period") (Press release, Fosun, AUG 27, 2025, View Source [SID1234655530]).

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In the first half of 2025, Fosun actively captured macroeconomic trends, maintained a clear strategic focus, and leveraged its strong capabilities in innovation and globalization to drive steady business development. Its long-term commitment to innovation led to multiple breakthroughs, with the innovative drug business entering a period of rapid growth. Globalization efforts continued to bear fruit. Overseas revenue contribution rose and expansion into emerging markets progressed steadily. In addition, Fosun fully embraced AI applications to empower its businesses, accelerating innovation and enhancing efficiency, while developing new growth points. Meanwhile, its "business streamlining, and advancements and exits" strategy delivered notable results, with asset structure further optimized and financial position remaining solid. During the Reporting Period, the Group’s total revenue reached RMB87.28 billion, industrial operation profit amounted to RMB3.15 billion, and profit attributable to owners of the parent reached RMB661.2 million.

The four core subsidiaries – Fosun Pharma, Yuyuan, Fosun Insurance Portugal and Fosun Tourism Group ("FTG") – achieved a total revenue of RMB63.61 billion in the first half of 2025, accounting for 73% of the Group’s total revenue. Fosun Pharma’s profit attributable to parent amounted to RMB1.7 billion in the first half of the year, representing a year-on-year increase of 38.96%. Yuyuan’s core businesses stabilized and began to recover, with the jewelry and fashion segment generating RMB12.9 billion in operating revenue during the first half of the year, including RMB7.6 billion in the second quarter, representing a substantial quarter-on-quarter increase. Fosun Insurance Portugal saw steady growth in both domestic and international businesses, achieving a net profit of EUR133 million, representing a year-on-year increase of 27.6%. FTG’s global operational capabilities continued to improve. Its business volume reached a record high of RMB9.53 billion, and adjusted net profit grew 42.0% year-on-year.

Meanwhile, Fosun continued to optimize its asset portfolio, maintaining a solid financial position with ample cash reserves. As at the end of the Reporting Period, the total debt to total capital ratio stood at 53%, with debt ratio remaining at a healthy level. In May 2025, the international credit rating agency S&P affirmed Fosun’s credit metrics and maintained its rating outlook as "Stable". The Group’s Hong Kong-listed companies in the Health segment saw a strong market capitalization performance in the first half of 2025, driving a revaluation of underlying asset values.

Guo Guangchang, Chairman of Fosun International, said: "In the first half of the year, we remained steadfast in implementing our core business-focused strategy. Our core segments—pharmaceuticals and healthcare, cultural tourism and consumption, financial services and insurance—delivered steady growth. In particular, we achieved several industry-leading breakthroughs in innovative drugs, which have not only been well received by the market but will also benefit more patients worldwide. Meanwhile, we continued to strengthen our global operating capabilities, allowing more competitive products and services to accelerate their expansion into international markets to serve a growing number of families."

Innovative drug business ushers in a period of rapid growth, fostering multiple "China’s first" and the "World’s first" innovations

Innovation is a core competence that Fosun has accumulated over a long period of time and has consistently adhered to. During the Reporting Period, Fosun’s investment in technology innovation reached RMB3.6 billion and its global innovation system integrating "independent R&D + investment incubation + ecosystem collaboration" continued to gain momentum, fostering a series of globally competitive innovations.

In terms of therapeutic drugs, a total of 5 indications of 4 innovative drugs independently developed and licensed-in by Fosun Pharma were approved for launch both domestically and internationally, 4 innovative drugs had entered the pre-launch approval stage. Among them, the Class I new drug independently developed by Fosun Pharma, FUMAINING (luvometinib tablets), was approved for marketing in Chinese mainland, filling the treatment gap in the field of rare tumors. In August 2025, the small molecule orally administered DPP-1 inhibitor developed by Fosun Pharma achieved overseas licensing for a potential total of US$645 million.

Henlius’ HLX43 is a PD-L1-targeting antibody-drug conjugate (ADC) currently in global Phase II clinical trials. It is undergoing clinical studies for solid tumors such as non-small cell lung cancer (NSCLC) and thymic carcinoma in countries including China, the United States, Japan, and Australia. HLX43 has demonstrated notable competitiveness in terms of drug safety, efficacy, and R&D progress, and holds strong potential to become a broad-spectrum anti-cancer drug. At the upcoming World Conference on Lung Cancer in September 2025, ten cutting-edge studies featuring Henlius’ innovative products, including HLX43, have been selected for presentation. In addition, HLX22, an innovative anti-HER2 monoclonal antibody, was granted Orphan Drug Designation (ODD) by the European Commission (EC) for the treatment of gastric cancer, marking it as the first anti-HER2-targeted therapy for gastric cancer to receive ODD approval from both the EU and the US. Henlius is continuously expanding its innovation pipeline in disease areas like oncology and autoimmune, advancing a differentiated portfolio of potential best-in-class (BIC) and first-in-class (FIC) candidates.

In addition, breakthrough progress has been made in the fields of medical devices and diagnostics. Leveraging the "licensed medical devices" permission in Hainan, the Da Vinci SP endoscopic single orifice surgical system has completed real-world study reports across multiple specialties, helping accelerate its formal registration and approval process. Meanwhile, the operating entity of the "MRgFUS" (MR guided focused ultrasound) brain therapy system, Fosun Insightec, is steadily advancing the registration of new models and the expansion into new indications.

In the field of cultural and tourism consumption, construction of FTG’s Taicang Alps Resort Phase II project commenced in June 2025, which will feature an indoor ski facility boasting five "world’s firsts". The project is scheduled to begin operations in June 2029.

Combining global resources with China’s capabilities, proportion of overseas revenue exceeds half of total revenue

Leveraging its business presence and profound industry operations in over 40 countries and regions around the world, Fosun’s overseas revenue saw steady growth. In the first half of 2025, overseas revenue reached RMB46.67 billion, accounting for 53% of the Group’s total revenue.

Henlius consistently achieved major breakthroughs in global operations during the Reporting Period. Its core innovative product HANSIZHUANG (serplulimab), the world’s first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of small cell lung cancer (SCLC), recorded a global sales revenue of RMB597.7 million. In the first half of 2025, HANSIZHUANG received approvals in the EU, Singapore, Malaysia, the United Kingdom and India for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Additionally, it was approved in Indonesia and Thailand for the treatment of squamous non-small cell lung cancer (sqNSCLC). To date, HANSIZHUANG has been successfully approved in nearly 40 countries and regions, covering nearly half of the world’s population. Henlius’ core breast cancer product HANQUYOU (trastuzumab), the "China-developed" mAb biosimilar approved in China, the EU, and the US, recorded a global sales revenue of RMB1.4442 billion in the first half of 2025. During the Reporting Period, HANQUYOU was newly approved in countries including Mexico, bringing its cumulative approvals to over 50 countries and regions worldwide.

During the Reporting Period, Henlius’ overseas products profits surged over 200%. Cash inflows from BD agreements exceeded RMB1 billion, surging 280% year-on-year. As the overseas sales volume of commercialized products continues to rise, the company expects significant growth in overseas revenue and profits for the full year of 2025, with strong momentum likely to continue into 2026.

Fosun rapidly advanced its pace of global expansion across more industries and business segments. Hainan Mining commenced pilot production at Phase 1 of the Bougouni lithium mine in Mali and will strategically initiate the planning of Phase 2 development. Leveraging its established projects such as the Bougouni lithium mine in Mali, Roc Oil oilfield project in Malaysia and the recently acquired oilfield project in Oman, Hainan Mining is accelerating the building of a "Minerals + Energy" network spanning West Africa, the Middle East, and Southeast Asia. Revenue from overseas operations has now increased to 57% of total revenue.

Following its overseas debut in Paris, France in late 2023, the Yuyuan Lantern Festival continued its overseas journey in 2025: In January, the themed lantern installation made a stunning appearance in Hanoi, Vietnam, commemorating the 75th anniversary of the establishment of diplomatic relations between China and Vietnam. In June, the Lantern Festival officially lit up at ICONSIAM, a renowned commercial landmark in Bangkok, Thailand, as part of the celebrations marking the 50th anniversary of the establishment of diplomatic relations between China and Thailand. In April 2025, Songhelou, a time-honored Chinese brand with a 268-year history, opened its first overseas restaurant in London, the UK, marking its debut on the international culinary stage.

At the same time, the global operations of Fosun’s overseas subsidiaries continued to grow. During the Reporting Period, Fosun Insurance Portugal’s international operations accounted for 28.2% of total consolidated business and overseas gross written premiums ("GWP") reached EUR924 million. In July 2025, S&P initiated coverage on Fosun Insurance Portugal and assigned it an "A" rating, recognizing its high-quality and well-balanced business portfolio, continuous international expansion, solid financial performance, and strong capital adequacy.

During the Reporting Period, Club Med’s global performance once again reached a record high. Its business volume amounted to RMB9.25 billion, representing a year-on-year increase of 3.8%; operating profit reached RMB1.27 billion, up 11.0% year-on-year. With strong demand continuing for the summer vacation season and the upcoming snow season, bookings are expected to witness sustainable growth in the second half of 2025 and the first half of 2026.

While strengthening its foothold in traditional markets, Fosun accelerated its expansion into global emerging markets. Fosun Pharma reached a strategic cooperation with Saudi Arabia’s comprehensive healthcare group, Fakeeh Care Group, to jointly promote the local introduction of innovative therapeutic products in Saudi Arabia. Easun Technology formed a joint venture with Saudi enterprise, Khaled Juffali Company, to provide production line solutions for Saudi Arabia’s electric vehicle industry and has already received its first order. The German asset servicing entity, HAFS, will leverage Fosun’s global network to expand into emerging markets in the Middle East and Asia, strengthening its asset-light operating model.

Fully embracing AI to develop new growth points

Amid the rapid rise of AI, Fosun has proactively embraced the trend, deeply integrating AI technologies into its diverse business scenarios to accelerate innovation and enhance operational efficiency.

In the field of biopharmaceuticals, Fosun Pharma tapped into AI productivity across all business scenarios by adopting a dual-engine approach that combines "biopharmaceutical models + large language models", building a knowledge platform to support high-quality AI applications. On the decision support front, Fosun Pharma launched the industry’s first decision intelligence platform, PharmAID. It integrates multiple global clinical information and pipeline databases, with data updated as frequently as T+1. The platform delivers higher content generation accuracy in the healthcare domain compared to general-purpose large models, and improves information extraction efficiency by 50% in areas such as R&D decision and evaluation, and pipeline optimization.

In the field of cultural tourism and consumption, Club Med continued to advance AI-driven digital transformation. The G.M Copilot conversational AI assistant, which provides 24/7 instant and personalized service, has already expanded to 12 markets worldwide, including Brazil, France, Belgium, Singapore, and Malaysia. In August 2025, FTG entered into a full-stack AI collaboration with Alibaba Cloud to jointly develop the cultural tourism intelligent system, "AI G.O", based on the Qwen3 model series. "AI G.O" is designed to optimize the entire vacation experience and enhance operational efficiency. It is scheduled for official launch at the end of September, with the first pilot program to be carried out at Atlantis Sanya.

In the field of finance services, Fosun Insurance Portugal leveraged its AI application system to comprehensively improve the efficiency of its entire business process and enhance data accuracy, driving rapid growth of its insurance business. During the Reporting Period, the total number of internet users of Fidelidade exceeded 2 million, representing nearly 20% of Portugal’s total population. By adopting AI technologies, the rate of fully automated processing for motor claims rose from 48% as at the end of 2023 to 66% as at the end of the Reporting Period.

In pursuit of new opportunities in fintech, Fosun Wealth accelerated its Web3 strategy. In July 2025, Finloop, independently incubated by Fosun Wealth, launched the FinRWA Platform (FRP). FRP is a globally leading one-stop solution for Real World Assets (RWA) technology, issuance and distribution, and Finloop is actively advancing multiple asset tokenization technology projects.

Committed to business for good, maintaining a leading ESG performance

During the Reporting Period, relying on Fosun’s continuous efforts in environmental, social, and governance (ESG) over the years, it was once again successfully included in S&P Global’s "Sustainability Yearbook 2025" and was selected as the top 1% in S&P Global’s "Sustainability Yearbook 2025 (China Edition)". In addition, Fosun’s FTSE ESG score continued to outperform the global industry average and the national average, and it has been included in the constituent stocks of the FTSE4Good Index Series for four consecutive years.

In terms of social welfare, Fosun Pharma has consistently contributed the "China Solution" to the fight against malaria in Africa. As at the end of June 2025, its independently developed artesunate for injection had been used to treat more than 84 million patients with severe malaria worldwide. Additionally, Fosun Pharma had supplied over 420 million doses of artesunate for injection globally.

In terms of rural revitalization, as at the end of June 2025, the Rural Doctors Program had covered 78 counties in 16 provinces, cities and autonomous regions (including 21 key counties for national rural revitalization), supported 25,000 rural doctors, and benefited 16.34 million rural residents and 3 million rural families.

Looking ahead, Guo Guangchang stated: "In the face of both opportunities and challenges, we will remain focused on our core businesses, step up innovation efforts, and firmly advance our globalization strategy. Building on our long-established core capabilities, we are committed to driving Fosun’s sustainable growth, scaling new heights in our areas of strength, expanding our leadership across more business areas, and creating greater value for our shareholders and society."

On August 27, 2025 Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, reported its interim results for the six months ended June 30, 2025 (Press release, Harbour BioMed, AUG 27, 2025, View Source [SID1234655529]).

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Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "In the first half of 2025, Harbour BioMed achieved several significant milestones. During the reporting period, the company’s profit grew more than fiftyfold year over year, demonstrating strong growth momentum. Out-licensing and collaborations based on our innovative products have contributed significantly to revenue growth and have become a recurring source of income.

These results underscore the sustainability of our ability to translate innovation into commercial value and reflect the success of our diversified business model, which includes strategic partnerships, licensing collaborations, platform collaborations, and innovation incubation. Leveraging our industry-leading Harbour Mice platform and its extended 2.0 technology platform, Harbour BioMed has built a strong global collaboration ecosystem, positioning the Company as a cornerstone of global antibody drug development.

Looking ahead, we will continue to focus on innovation and accelerate the development of next-generation biologics to deliver better treatment options for patients worldwide."

As of June 30, 2025, Harbour BioMed reported total revenue of approximately US$101.3 million for the first half of the year, representing a 327% increase year over year. Net profit reached approximately US$73.0 million, a 51-fold increase compared with the same period in 2024. The Company also reported a strong cash position of about US$320 million, a 92% increase since the end of the previous year.

During the reporting period, the company delivered strong performance, highlighting the success of its business model and solid financial position.

Advancing a Robust and Differentiated Pipeline

Harbour Therapeutics, a sub-brand parallel to Nona Biosciences, is now individually responsible for the development of the Company’s products pipeline on immunology and oncology. Harbour Therapeutics has established a rich and differentiated pipeline and continues to expand collaborations with leading global pharmaceutical companies and academic institutions to efficiently advance its programs. During the reporting period, several key clinical-stage projects achieved significant progress, alongside continued advancement of a robust portfolio of next-generation therapies.

Key products in the clinical stage include:

Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody completed Phase I to pivotal trials in China. As a novel, fully human anti-FcRn monoclonal antibody, batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases. In December 2023, the Company voluntarily planned to include additional long-term safety data and re-submitted the Biologic License Application (BLA) for batoclimab to the National Medical Products Administration of China (NMPA) in June 2024. In July 2024, NMPA accepted the BLA for batoclimab for the treatment of gMG. The Phase III pivotal clinical trial results of batoclimab were published in JAMA Neurology in March 2024, demonstrating sustained efficacy and safety with long-term use of batoclimab in the treatment of gMG.

HBM9378 is a fully human monoclonal antibody against thymic stromal lymphopoietin (TSLP) generated from the H2L2 Harbour Mice platform. It binds to the TSLP ligand and inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP is a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological conditions, including asthma and chronic obstructive pulmonary disease (COPD), where its inhibition has demonstrated benefit in a wide array of inflammatory phenotypes. HBM9378 has been engineered to achieve an extended half-life and effector silencing and is subcutaneously administered.

The Company received IND approval of HBM9378 for moderate-to-severe asthma from the NMPA in February 2022 and completed a Phase I clinical trial in healthy subjects in China. In November 2024, the Company submitted an IND application for HBM9378 for COPD to the NMPA, which was approved in January 2025.
In January 2025, the Company and Kelun-Biotech entered into an exclusive license agreement with Windward Bio, under which Windward Bio was granted an exclusive license for the research, development, manufacturing and commercialization of HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). In July 2025, Windward Bio initiated the global phase 2 POLARIS trial to evaluate the dosing, safety, and efficacy of HBM9378/WIN378 in patients with asthma. Initial data are expected in mid-2026.
Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favourable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. The Company has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, CRC, NEN and HCC. Final data from the study of HBM4003 in combination with toripalimab for advanced HCC were published in Clinical Cancer Research in August 2025. Data from the Phase II study of HBM4003 in combination with tislelizumab for the treatment of microsatellite stable (MSS) metastatic colorectal cancer will be presented at the ESMO (Free ESMO Whitepaper) Congress 2025.

HBM1020 is a first-in-class fully human monoclonal antibody generated from the H2L2 Harbour Mice platform targeting B7H7. As a newly discovered member of the B7 family, B7H7 expression is found to be non-overlapping with PD-L1 expression in multiple tumor types, potentially playing a more significant role in tumor immune evasion. With its excellent product design and target features, HBM1020 presents great potential to address significant unmet medical needs for solid tumors. In September 2024, the Company presented the latest clinical data for patients with advanced solid tumors at the ESMO (Free ESMO Whitepaper) Congress 2024. The data demonstrated excellent safety and tolerability profiles for HBM1020. Of the 15 patients who received post-treatment tumor assessments, 7 patients (46.7%) achieved stable disease (SD), with two patients showing tumor shrinkage of 11% and 25%.

Key products in the next-generation innovation portfolio include:

HBM7004 is a novel B7H4xCD3 bispecific antibody. Using HBICE bispecific technology and Harbour Mice platform, this bispecific antibody was designed to provide innovative solutions for cancer immunotherapy from both efficacy and safety perspectives. The development of B7H4xCD3 bispecific HBICE further consolidates the Company’s bispecific immune cell engager platform, demonstrating the HBICE platform’s versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window. The Company is currently conducting IND-enabling studies for HBM7004.

HBM7020 is a BCMAxCD3 bispecific antibody generated using the fully human HBICE bispecific technology and Harbour Mice platform. HBM7020 can crosslink targeted cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and cell elimination. By incorporating dual anti-BCMA binding sites for optimal cell targeting and monovalent-optimized CD3 activity to minimize CRS, HBM7020 demonstrated potent cytotoxicity with broad applications in both immunological and oncology diseases. In August 2023, HBM7020 obtained IND clearance from the NMPA to commence a Phase I trial for cancer in China. In 2024, the Company restructured its development strategy to target immunological diseases. In June 2025, Harbour BioMed entered global strategic collaboration with Otsuka. Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020 globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan).

R2006 (CD19xCD3 bispecific antibody) and HBM7026 (BCMAxCD19xCD3 trispecific antibody) are two T-cell engagers (TCEs) in preclinical development. TCEs have emerged as an important therapeutic strategy for autoimmune diseases, as B-cell depletion has been shown to help restore immune system balance in multiple autoimmune conditions. TCEs can achieve deep depletion of B cells in peripheral blood, lymph nodes, and bone marrow, thereby resetting the immune system. Newly generated B cells subsequently return to a naïve and non-pathogenic state, potentially reducing inflammation and autoimmune responses. CD19 is a marker broadly expressed on precursor and mature B cells, while BCMA is highly expressed on mature B cells and plasma cells. Leveraging its fully human HCAb technology and optimized anti-CD3 antibodies, Harbour BioMed is developing TCEs with enhanced safety, reduced immunogenicity, and lower risk of cytokine release syndrome.

In March 2025, Harbour BioMed launched Élancé Therapeutics ("Élancé"). Harnessing Harbour BioMed’s proprietary HCAb-based bispecific antibody technology, Élancé aims to develop innovative therapies addressing key challenges in current obesity treatment, including muscle preservation and long-term efficacy. Élancé is building a metabolic disease pipeline of multiple preclinical bispecific antibody programs. By integrating dual-targeting strategies with enhanced safety profiles, these therapies have the potential to complement and expand upon existing treatment options, including various agonists of GLP-1 receptor, GIP receptor, and GCG receptor and further expand the boundaries of obesity treatment.

Harbour BioMed is leveraging its fully human antibody and HCAb platforms to develop next-generation biologics for central nervous system (CNS) disorders, including bispecific antibodies and other "Antibody-Plus (Ab+)" therapies. The pipeline in this area is currently under development, with the goal of creating more complex molecules to address the treatment challenges of CNS disorders, including neurodegenerative diseases and neuroinflammation.

Maximizing Platform Potential Through Diversified Collaborations

Harbour BioMed remains committed to global collaboration. In March 2025, the Company entered into a global strategic collaboration with AstraZeneca to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond. The strategic collaboration includes an option to license multiple programs utilizing Harbour BioMed’s proprietary Harbour Mice fully human antibody technology platform in multiple therapeutic areas. Furthermore, AstraZeneca acquired 9.15% newly issued shares of Harbour BioMed with a $105 million equity investment. Harbour BioMed will establish an innovation center in Beijing, China to be co-located with AstraZeneca.

During the reporting period, Harbour BioMed also signed several licensing and collaboration agreements with global partners. In January 2025, the Company and Kelun-Biotech entered into a licensing agreement with Windward Bio for HBM9378/SKB378 (also known as WIN378), granting Windward Bio to research, develop, manufacture, and commercialize HBM9378/SKB378 globally, excluding Greater China and several Southeast and West Asian countries. In June 2025, Harbour BioMed entered a global strategic collaboration with Otsuka Pharmaceutical to advance the development of HBM7020, a BCMA x CD3 bispecific T-cell engager for the treatment of autoimmune diseases.

In February 2025, Harbour BioMed entered into a strategic collaboration with Insilico Medicine, a clinical-stage biotechnology company powered by generative AI, to accelerate the discovery of novel therapeutic antibodies by combining complementary strengths in antibody discovery and artificial intelligence.

Leveraging its technological advantages, Harbour BioMed established Nona Biosciences to better empower industry innovators and support collaborators by providing integrated solutions from "Idea to IND" (I to ITM). As a global biotechnology company, Nona Biosciences has established innovative platforms in antibody discovery, protein engineering, antibody-drug conjugation, HCAb-CAR screening, and drug delivery technologies, to accelerate the development of next-generation therapies across academic institutions, leading biotech companies, and multinational pharmaceutical companies.

In December 2024, Nona Biosciences entered into a collaboration with Kodiak Sciences (Nasdaq: KOD). This partnership aims to advance the discovery of novel multi-target antibodies to treat ophthalmic diseases, leveraging Nona’s proprietary Harbour Mice fully human antibody platform. In the same month, Nona Biosciences announced a research collaboration and license agreement with Candid Therapeutics to discover next-generation TCEs. In the first half of 2025, Nona Biosciences further expanded its global partnerships, entering into collaborations with Invetx, the University of Alabama at Birmingham, Atossa Therapeutics, and Visterra, unlocking the potential of its proprietary platforms to support partners in advancing biotherapeutics pipeline development and related research.

In addition, Nona Biosciences continues to expand the capabilities of its technology platforms. In March 2025, Nona Biosciences launched Hu-mAtrIx, an innovative AI-assisted drug discovery engine integrates seamlessly with the company’s proprietary Harbour Mice technology platform, aiming to accelerate antibody discovery across multiple key therapeutic areas, including neurodegenerative and metabolic diseases, and more.

These collaborations further highlight the Company’s unique strengths in advancing innovation. Building on its industry-leading technology platforms and flexible business model, the Company will continue to expand capabilities, strengthen partnerships, and maximize platform value.

Incubating Breakthrough Therapies for the Future

Harbour BioMed continues to explore the scalability of its platform applications to fully unlock their potential. The Company is incubating several joint ventures focused on next-generation therapies, including multivalence antibodies, cell therapies, and more. By expanding the application scope of its platform technologies, Harbour BioMed aims to create additional value and accelerate next-generation innovation.

In November 2024 and July 2025, NK Cell-Tech (an incubated company of Harbour BioMed) announced the completion of its Series A++ and Series A+++ financing rounds, respectively, to further advance its pipeline development and clinical progress.
In February 2025, HBM Alpha Therapeutics, a joint venture between Harbour BioMed and Boston Children’s Hospital (an affiliate of Harvard Medical School), announced a strategic collaboration and license agreement with a business partner.
In March 2025, Harbour BioMed launched Élancé Therapeutics, a new venture leveraging the Company’s proprietary HCAb-based bispecific antibody technology to develop innovative therapies addressing key challenges in current obesity treatment, including muscle preservation and long-term efficacy. In addition, Élancé will refine and expand Nona Biosciences’ Hu-mAtrIxTM AI platform to support bispecific antibody discovery, with AI applications guiding antibody sequence discovery, enrichment, optimization, bispecific geometry design, and developability/immunogenicity/pharmacokinetics (PK) assessments, as well as patient biomarker studies.
Prospects and Outlook: Innovation and Collaboration

The achievements and growth momentum Harbour BioMed demonstrated in the first half of 2025 give us strong confidence in the future. Harbour BioMed has proven its ability to successfully navigate a complex market environment and is well-positioned to deliver innovative therapies for patients with immunology and oncology diseases in the near future.

Since its establishment, Harbour BioMed has been committed to developing innovative therapies for patients worldwide and has grown into an innovative biopharmaceutical company distinguished by its proprietary technologies and differentiated pipeline. In 2024, the Company successfully completed the BLA submission for HBM9161. Harbour BioMed will further accelerate the advancement of its portfolio, progressing multiple clinical trials for innovative programs which target both novel and established pathways, including HBM4003, HBM9378, and HBM1020. In addition, Harbour BioMed is expanding the capabilities of its platforms into immunology and inflammation, leveraging its powerful Harbour Mice and HBICE drug discovery engines to continue identifying novel high-quality candidates.

The value of Nona Biosciences’ antibody discovery platform and flexible collaboration model has been fully validated through a series of partnerships since its establishment in 2022. Building on this foundation, Harbour BioMed continues to strengthen global collaborations, offering one-stop solutions to academic institutions, biotech startups, and multinational pharmaceutical companies, and unlocking the full potential of its platforms through business partnerships. Looking ahead, Harbour BioMed will continue to advance its globalization strategy. As its preclinical products mature, the company expects to welcome more global collaboration opportunities in 2025.

Accordingly, Harbour BioMed will further optimize internal resource allocation, focus on advancing self-developed assets from its proprietary platforms, and continue expanding Nona Biosciences’ collaboration network—injecting fresh momentum into the Company’s long-term sustainable growth.

On August 27, 2025 Northwest Biotherapeutics, Inc. (OTCQB:NWBO) (the "Company" or "NWBio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that it has entered into an agreement to acquire Advent BioServices Ltd. from its owner, Toucan Holdings LLC (Press release, Northwest Biotherapeutics, AUG 27, 2025, View Source [SID1234655528]). The transaction is expected to close as soon as certain legal conditions are fulfilled. At closing, Advent will become a wholly owned subsidiary of the Company, and this is expected to enable the Company’s operations to become fully integrated. The acquisition is also expected to enhance the Company’s positioning for scale-up of operations, and yield important synergies and cost savings.

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As part of the acquisition, the Company will receive all of Advent’s fixed assets, including extensive cryostorage and other equipment purchased by Advent over the last several years. In addition, 19 million NWBio securities that were previously issued to Advent as payment for contract services will revert back to the Company (13.5 million shares and 5.5 million options). Certain intellectual property and other intangibles that Advent has acquired will also transfer to the Company.

As reported in the Company’s recent Form 10-Q, the Company and Advent have been doing strategic planning for some time to consolidate the operations of the London GMP facility and the Sawston GMP facility. The parties have also been planning for increased focus on ramp-up of manufacturing in Sawston, now that years of intensive product and process development work have been completed by Advent for the Marketing Authorization Application (MAA) and the DCVax-Direct program. Joining the two companies is expected to facilitate implementation of these plans.

The consideration for the acquisition will be paid in installments over two years, beginning 90 days after the acquisition agreement, with potential acceleration after regulatory approval of the Company’s DCVax-L product. The consideration will include a payment of £1.4 million, and payment of the net amount of accounts payable ("Net AP") due from the Company to Advent as of the date of the acquisition agreement for services already performed by Advent under the existing service contracts and Statements of Work (SOWs) that have been reported in the Company’s public filings. The Net AP payable by the Company will be the outstanding accounts payable on the agreement date reduced by certain adjustments between the parties.

"This is an exciting day for the Company, entering into an agreement to bring its manufacturing and product development operations in-house," commented Linda Powers, the Company’s CEO. "We believe this is an opportune time to join forces under one roof, integrating our teams, streamlining our processes, increasing our efficiency and preparing for potential substantial scale-up of our capacity."

On August 27, 2025 10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, reported that members of its management team will participate in a fireside chat at the Morgan Stanley 23rd Annual Global Healthcare Conference on Wednesday, September 10, at 11:30 a.m. Eastern Time (Press release, 10x Genomics, AUG 27, 2025, View Source [SID1234655527]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Interested parties may access a live webcast of the fireside chat on the "Investors" section of the company’s website at: View Source The webcast will be archived and available for replay for at least 30 days after the event.