On August 28, 2024 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), reported its operating performance for the first half of 2024 (the "Reporting Period") (Press release, Fosun Pharma, AUG 28, 2024, View Source [SID1234646173]). During the Reporting Period, Fosun Pharma achieved revenue of RMB20.46 billion, an increase of 5.31% YoY after excluding COVID-related products. The net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss amounted to RMB1.3 billion. In the second quarter of 2024, the net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss was RMB646 million, a quarter-on-quarter increase of RMB37 million.

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As a global innovation-driven pharmaceutical and healthcare industry group, Fosun Pharma continuously advance its innovation transformation and the development and commercialization of innovative products. In the first half of 2024, Fosun Pharma’s revenue from key innovative products in pharmaceuticals business grew steadily, exceeding RMB3.7 billion.

In 2024, Fosun Pharma continued to boost operational efficiency and profitability, laying the foundation for long-term sustainable development. During the Reporting Period, the gross margin minus the selling and distribution expense ratio increased by 1.72 percentage points YoY; excluding the impact of newly acquired companies, the management expense decreased by about RMB0.2 billion. During the Reporting Period, Fosun Pharma ensured stable free cash flow through measures including optimizing operating cash flow, supply chain management, and controlling capital expenditures, achieving operating cash flow of RMB1.9 billion, a period-on-period increase of 5.36%, exceeding the growth of operating profit. In addition, the Group continued to optimize asset structure and improve asset efficiency. Since 2024, the cash inflow from asset disposals and the expected cash inflow from contracts signed by Fosun Pharma exceeded RMB2 billion in aggregate.

Revenue from innovative products maintains steady growth, with a further focus on innovative drugs and high-value devices
In the first half of 2024, Fosun Pharma further focused on innovative drugs and high-value devices. Four key innovative products with a total of 9 indications, independently developed and licensed-in by the Group, were approved for launch domestically and internationally. In addition to the key innovative products, Fosun Pharma also had 38 generic drug varieties approved for launch domestically and internationally.

In the first half of 2024, Fosun Pharma’s pharmaceutical manufacturing segment achieved revenue of RMB14.7 billion. The innovative drug business achieved breakthroughs in core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation, and realized multiple innovative achievements in hematologic tumors, breast cancer and lung cancer, benefiting patients worldwide.

Han Si Zhuang (serplulimab injection), Fosun Pharma’s first self-developed biopharmaceutical innovative drug, as well as the world’s first anti-PD-1 monoclonal antibody (mAb) approved for the first-line treatment of small cell lung cancer (SCLC), was commercialized in the domestic market in March 2022. Up to now, it has been approved for 4 indications, broadly covering high-incidence tumours including lung cancer and gastrointestinal cancer, benefiting over 75,000 patients globally. Additionally, the 5th NDA of Han Si Zhuang for the first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA) in China.

During the Reporting Period, Fosun Pharma’s self-developed biosimilar Han Da Yuan (adalimumab injection) received 4 new indications approval from the NMPA. It has now been approved for eight indications in China, covering all indications of originator adalimumab in China, providing more treatment options for adult and pediatric patients with autoimmune diseases.

Fosun Pharma adheres to an open innovation strategy, and actively expands its pipelines through BD in addition to independent R&D. In June 2024, Su Ke Xin (avatrombopag malate tablets), which is exclusively commercialized by Fosun Pharma, received approval in Chinese mainland for a second indication for the treatment of adult patients with chronic primary immune thrombocytopenia (ITP) who have shown poor response to prior treatment, further benefiting ITP patients in China. Additionally, certain domestic innovative drugs licensed-in by the Group such as Bei Wen (keverprazan hydrochloride tablets) and Pei Jin (telpegfilgrastim injection), were officially included in the National Medical Drugs Catalogue in January 2024. This significantly enhanced the accessibility of drugs for relevant diseases within Chinese mainland and practically reduced the burdens of drugs on patients, aiming to improve the living and life quality of patients through regulated therapies.

In the field of vaccines, Fosun Pharma has established an independent R&D system centered on two major technical platforms: bacterial vaccines and viral vaccines. In March 2024, the rabies vaccine (Vero cell) for human use (freeze dried), which is independently developed by the Group, has been approved for launch in Chinese mainland. The production line has also passed the GMP compliance inspection.

Research progress on various pipelines develops rapidly to secure innovative development
To meet the unmet clinical needs, through diversified and multi-level cooperation models such as independent R&D, co-development, license-in and industrial investment, Fosun Pharma continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. In the first half of 2024, Fosun Pharma’s total R&D expenditure amounted to RMB2.7 billion, with R&D expenses totaling RMB1.9 billion. The R&D expenditure in the pharmaceutical manufacturing segment amounted to RMB2.4 billion, accounting for 16.4% of the segment’s revenue. In particular, R&D expenses were RMB1.6 billion, accounting for 10.7% of the segment’s revenue.

In the first half of 2024, 4 innovative drugs/biosimilars with a total of 9 indications independently developed, co-developed and licensed-in by the Group had entered the pre-launch approval/critical clinical stage. The pharmaceutical manufacturing segment of the Group submitted 124 patent applications, including 2 American patents applications, 8 PCT applications, and the Group has obtained 37 licensed invention patents authorization.

During the Reporting Period, the New Drug Application (NDA) of self-developed selective MEK1/2 inhibitor (project code: FCN-159) for two indications was accepted by NMPA in May and June 2024, both of which were included in the priority review procedure. The Marketing Authorization Application (MAAs) for five indications of the self-developed denosumab biosimilar HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection) was accepted by the European Medicines Agency (EMA).

Additionally, during the Reporting Period, the Phase 3 clinical trials for its self-developed Han Si Zhuang (serplulimab injection), in combination with bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC) patients, had commenced in the Chinese mainland. The combination dosing of OP0595 and cefepime or aztreonam, developed by Fosun Pharma in collaboration with Meiji Seika Pharma Co., Ltd., for the treatment of adults infected by aerobic gram-negative bacteria with limited options, had commenced two phase III clinical trials in China.

During the Reporting Period, clinical data from multiple pipeline products and marketed products of Fosun Pharma were presented at global industry conferences, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), American Association for Cancer Research (AACR) (Free AACR Whitepaper), and the European Hematology Association (EHA) (Free EHA Whitepaper), further demonstrating the Group’s innovative R&D capabilities on the international stage.

In addition to independent R&D, Fosun Pharma actively practices an open R&D model, engaging in the incubation and investment of R&D projects through initiatives such as the establishment and management of industrial funds, ensuring the sustainability of its innovation pipeline. During the reporting period, Fosun Pharma successfully completed the establishment and filing of Shenzhen Biopharma Industrial Fund with fundraising size of RMB5.0 billion

Continues to enhance global operation capabilities and gains international recognition for innovative products
Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, two-way license, production and operations as well as commercialization to enhance operational efficiency and strengthen global market layout while covering major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia. As at the end of the Reporting Period, the Group had formed an overseas commercialization team of approximately 1,000 employees. For the first half of 2024, overseas revenue reached RMB5.5 billion, an increase of 15.13% YoY, accounting for 26.93% of total revenue.

During the Reporting Period, Fosun Pharma’s self-developed Han Qu You (trastuzumab injection, trade name: HERCESSI in the U.S., Zercepac in Europe) received the U.S. FDA approval for three indications covering the treatment of breast cancer and gastric cancer, becoming the first domestic biosimilar approved for launch in China, the EU and the United States. Additionally, through collaboration with global renowned pharmaceutical companies, Fosun Pharma has established a presence in Europe, the United States, Canada, and numerous emerging markets. Up to date, Han Qu You has been approved in 48 countries and regions, benefiting 200,000+ patients, bringing affordable and high-quality treatment options to breast cancer and gastric cancer patients worldwide.

Self-developed biopharmaceutical innovative drug of Fosun Pharma, Serplulimab Injection (anti-PD-1 monoclonal antibody, Chinese trade name: Han Si Zhuang) completed the first international shipment in January 2024, making it the first Chinese anti-PD-1 mAb approved for launch in Southeast Asia. The marketing authorization application (MAA) of Han Si Zhuang has been accepted in March 2023 and its head-to-head bridging trial comparing to first-line standard of care with Atezolizumab for extensive-stage small cell lung cancer (ES-SCLC) had entered clinical enrollment stage in the United States. At the same time, Fosun Pharma has established an innovative drug team in the United States to advance the commercialization of Serplulimab Injection.

Fosun Pharma actively introduces leading international technologies and products into the Chinese market to benefit more patients. During the Reporting Period, the Headquarters Industrial Base of the joint venture Intuitive Fosun officially opened and was put into operation in Shanghai Zhangjiang International Medical Park. The base integrates R&D, production and training, and its operation will further accelerate the localization process of the Da Vinci Surgical System. As at the end of June 2024, the accumulated total installation volume of the Da Vinci Surgical Robot in Chinese mainland and Hong Kong S.A.R.and Macau S.A.R. was over 380 in more than 300 hospitals. More than 540,000 patients had benefited from the Da Vinci Surgical Robot’s precise treatment and returned to normal life. During the Reporting Period, Fosun Pharma’s joint venture with Insightec, Fosun Insightec, made steady progress in the commercialization, clinical application and research of magnetic resonance-guided focused ultrasound treatment system for neurological diseases (MRgFus brain therapy system) in Chinese mainland, Hong Kong S.A.R and Macao S.A.R..

As a global pharmaceutical and healthcare industry group, Fosun Pharma continues to promote the building of production system with international quality standard, with its quality management system and production capabilities recognized by leading international certification authorities, laying a solid foundation for the overseas distribution of preparations. As at the end of the Reporting Period, all production lines of the domestic subsidiaries under the pharmaceutical manufacturing segment of the Group obtained domestic GMP certifications and 10 production lines had passed GMP certification in major regulatory markets such as the U.S. and the EU.

"Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma consistently focuses on unmet clinical needs, prioritizes innovative R&D, adheres to technology-driven and product-driven approach, and strengthens global operation capabilities, ensuring steady and sustainable development." Wu Yifang, Chairman of Fosun Pharma, said, "Looking forward, Fosun Pharma’s internal operation will be further improved in quality and efficiency, continuing to enhance its leading position in hematologic tumors, breast cancer, lung cancer and other fields while expanding footprint in immunity inflammation, chronic diseases and central nervous system. We will also intensify industry-university-research strategic cooperation with world-class universities and research institutions to capture innovative products at an early stage. At the same time, we will actively promote the overseas export of high-quality products and promote global simultaneous development, aiming to become the global leading integrator of pharmaceutical and healthcare innovation."

On August 28, 2024 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 2024 interim results and major business updates (Press release, Innovent Biologics, AUG 28, 2024, View Source [SID1234646172]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "For the first half of 2024, our company’s strategy of sustainable growth and global innovation continue executing very well: we achieved strong revenue growth, improved operational efficiency in all areas, and reached significant milestones in our late-stage pipeline to support our sustained growth. We also reported promising data readouts from early-stage assets, reinforcing our confidence in achieving global innovation and contributing to new long-term opportunities. The successful first half of 2024 has laid a solid foundation for achieving our full-year’s growth. With strong commercial and financial execution, a high-value late-stage pipeline, and disciplined investments in next-generation innovation, we are well-positioned to deliver long-term value for patients, employees, shareholders and society."

Enhanced operational efficiency and strong financial performance

Strong revenue growth momentum: total revenue was RMB3,952.3 million in the first half of 2024, with a strong year-over-year growth of 46.3%, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model.
Significantly improved financial performance: EBITDA Loss was significantly reduced, driven by strong revenue growth, enhanced operational efficiency and notable financial improvement.
The gross profit margin of total revenue was 84.1%, a year-over-year increase of 1.8 percentage points
The selling and marketing expenses of product revenue was 48.6%, a year-over-year decrease of 5.9 percentage points
The administration and expenses of total revenue was 5.2%, a year-over-year decrease of 4.9 percentage points
R&D expenses were RMB1,293.9 million; cash and short-term financial assets were RMB10,112.3 million, or approximately over USD1.4 billion, which enables us to focus on the long-term sustainable development
EBITDA loss was RMB160.8 million, a notable year-over-year decrease of 39.9%
Note: The financial numbers mentioned above were based on non-IFRS measure. Detailed disclosure can be found at the Company’s 2024 interim results announcement.

Strong product revenue growth; preparing for CVM commercialization

Product sales revenue reached RMB3,811.4 million in the first half of 2024, a strong year-over-year growth of 55.1%.
Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage[1],[2] and patient access:
Eleven approved products: TYVYT, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE, Olverembatinib, CYRAMZA, Retsevmo, FUCASO , SINTBILO and DUPERT (new product, KRAS G12C inhibitor) .
TYVYT and PEMAZYRE were newly approved in the Macau market.
TYVYT and BYVASDA were included in the NRDL for the treatment of EGFR-mutated NSCLC.
Solidify oncology leadership; in active preparation for new commercial opportunities in general biomedicine.
Oncology: we strengthened our leadership with a robust product portfolio, including TYVYT (sintilimab injection), and expanded out oncology business with a 10th product, a ROS1 inhibitor, set for approval in the second half of 2024.
General biomedicines: Following the approval of the first CVM product SINTBILO (tafolecimab injection) in 2023, we have successfully submitted three new drug applications (NDA)—two for mazdutide, targeting obesity/overweight population and T2D, and one for IBI311 (IGF-1R) for thyroid eye disease (TED). As a key strategic priority, we are steadily building our commercialization capabilities in the CVM field with systematic approaches, aiming to unlock substantial commercial opportunities and drive sustainable growth.
Material innovation delivery supports strategic goals

7 new assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early-phase clinical studies

Substantial milestones delivered for key late-stage assets

Encouraging progress in the next wave innovation of "IO+ADC"
TYVYT (sintilimab): submitted an NDA for its eighth indication, 2L endometrial cancer (EMC). New registrational clinical trials for neoadjuvant therapy in colon cancer and perioperative therapy in NSCLC have been initiated. Additionally, we are exploring the potential of combination therapies through multiple collaborations with novel modalities.
IBI310 (CTLA-4)：initiated a Phase 3 clinical trial for IBI310 in combination with sintilimab as neoadjuvant therapy in treating colon cancer.
IBI343 (CLDN18.2 ADC)：Phase 1b positive data readout in GC and a Phase 3 trial is in preparation.
Accelerating new launch momentum in general biomedicine to unlock significant opportunities
Mazdutide (GLP-1R/GCGR) : first NDA for weight management in obese or overweight populations and second NDA for T2D treatment, both under NMPA review. We plan to develop new indications, including adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), obstructive sleep apnea (OSA), and heart failure with preserved ejection fraction (HFpEF).
Teprotumumab (IGF-1R) : the NDA for TED is under NMPA review. With a longstanding lack of innovative TED treatments in China, Teprotumumab is set to be a transformative therapy for this significant unmet need once approved.
Picankibart (IL-23p19) : the only IL-23p19 that reported over 80% subjects achieving ≥90% improvement in Psoriasis and Severity Index (PASI90) in 16 weeks of treatment, along with strong long-term skin clearance maintenance and quarterly dosing interval advantage. We plan to submit an NDA in the second half of 2024.
IBI128 (XOI) : potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is currently undergoing overseas Phase 3 clinical trials overseas with our partner LG Chem, and we have completed patient enrollment for a Phase 2 clinical trial in China.
IBI302 (VEGF/C) : Phase 3 study initiated for the treatment of nAMD, following stable and robust visual benefit observed with an extended dosing interval and potential macular atrophy inhibition in two Phase 2 studies.
Abundant early-stage pipeline to support long-term growth and global ambition

Encouraging data readouts from multiple oncology assets in Phase 1 studies, eyeing most difficult-to-treat cancers
IBI363 (PD-1/IL-2α-bias) : preliminary positive signals in multiple IO-failed/cold tumor types; further investigations across different rumor types are ongoing; a Phase 2 clinical trial in the U.S. has been initiated.
IBI343 (CLDN18.2 ADC) : encouraging positive signal in pancreatic cancer, with FDA fast track designation granted. Plans are underway for a clinical trial in the U.S.
IBI389 (CLDN18.2/CD3) : encouraging and differentiated signals in GC and PDAC in Phase 1 studies; Phase 1b study is continuing.
Multiple programs ongoing including IBI3003 (GPRC5D/BCMA/CD3), IBI115 (DLL3/CD3); IBI3004 (DR5/CEA); IBI3001 (EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC)
Develop next-generation general biomedicine programs to improve chronic disease treatment
IBI3016（AGT siRNA）: a new-generation siRNA drug candidate, entered into a Phase 1 clinical trial for hypertension.
IBI355 (CD40L), IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP) : innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases.
IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy.
Research innovation published in high-impact scientific journals and medical conferences, such as:

AACR, ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) GI and ESMO (Free ESMO Whitepaper) plenary for oncology pipeline innovation, including 10+ oral presentations
ADA, APAO, ICE, CSE for general biomedicine pipeline material progress, such as mazdutide and teprotumumab
Facilitates and Manufacturing capacity adhering to high-standard quality:

Shanghai R&D center (medical) is newly operational in August 2024
First manufacturing site: 60,000L antibody production capacity and ADC production lines in operation
Second manufacturing site: first phase of 80,000L completed construction to secure CDMO business
Devoted to responsible business practices and enhancing ESG management practices

We remain committed to sustainable development, corporate responsibility and
ethical business practices. We newly launched our ESG website to enhance our efforts in sustainability, corporate responsibility and ethical business conduct. The new platform highlights our initiatives, policies and performance in key ESG areas, including "Excellent Governance", "Enjoying Good Health", "Ensuring High-Quality Products", "Empowering Employees", and "Embracing Ecology".
Innovent is graded ‘A’ level in MSCI ESG rating, ranking at the forefront of the biotechnology industry.

On August 28, 2024 Asieris Pharmaceuticals reported its 2024 Semi-Annual Report, showcasing a strong growth momentum (Press release, Asieris Pharmaceuticals, AUG 28, 2024, View Source [SID1234646171]). The launch of its blockbuster product APL-1702 is progressing smoothly, while the Commercial Team continues to enhance revenue-generating capabilities. The company’s pipeline is advancing and broadening, currently with 13 major products and 18 ongoing research projects. As of the end of this reporting period, Asieris had approximately RMB 2.024 billion in cash, cash equivalents, and financial assets held for trading, ensuring ample capital for the company’s continued growth and expansion.

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Advancing Launch of APL-1702 to Meet Strong Demand for Non-Invasive Treatment of Precancerous Cervical Lesions

The new drug application for APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), was accepted by the National Medical Products Administration (NMPA) in May 2024. The review process is progressing smoothly.

APL-1702 is a groundbreaking product that combines innovative, clinical, and social value. As a first-in-class treatment to be debuted in China, backed by proven efficacy in an international phase III trial, it is poised to become the world’s first non-invasive therapy for HSIL. Clinically, APL-1702 is set to redefine the treatment paradigm of precancerous cervical lesions, moving beyond the one-size-fits-all approach of cervical resection. It aims to reverse disease progression while preserving the cervix, avoiding damage from resection, and supporting long-term management and recurrence prevention. From a societal perspective, managing HSIL patient is a crucial step in the "early diagnosis and early treatment" of cervical cancer. APL-1702 combines the value of early cervical cancer intervention and the promotion of a fertility-friendly society, and it is expected to contribute to the success of the Action Plan for Accelerating the Elimination of Cervical Cancer (2023-2030) and the Healthy China Initiative.

To support the commercialization of APL-1702, the company formally established the Women’s Health Business Unit in early 2024. This unit is responsible for the domestic commercialization of APL-1702 in the Chinese market and expanding the company’s gynecological pipeline. Key members, including the BU head and teams for marketing, government affairs, and regional commercialization, have already come on board, all bringing extensive experience in gynecology and multinational pharmaceutical companies. In the first half of this year, the Women’s Health Business Unit conducted thorough market and industry research, developed a key launch plan for APL-1702, and actively prepared the commercial supply chain to ensure the product’s rapid market availability following its approval.

The company has also convened three expert consultation meetings focusing on key topics such as review and dissimilation of phase III clinical data of APL-1702, the current state of HSIL diagnosis and treatment, and clinical needs. The meetings garnered strong endorsements from the principal investigators and leading national gynecologists, highlighting the innovation and clinical value of APL-1702. With this expert backing, the Women’s Health Business Unit is pursuing strategic partnerships with government departments and industry associations to advance cervical cancer control and help shape a long-term management framework for precancerous lesions. Preparations are well underway, and a cooperation agreement is expected to be signed and implemented in the second half of the year.

Given the scarcity of innovative drugs in gynecology, APL-1702 stands out with its solid clinical evidence and proven efficacy. Moving forward, the company will leverage APL-1702 and its drug-device combination platform to build a robust gynecological portfolio through external partnerships, indication expansion, and proprietary second-generation products.

Commercial Capabilities Continue to Strengthen: Operating Revenue Increased by 130.98% from Q1 to Q2

During this period, the company’s commercial team’s revenue-generating capabilities continued to strengthen. In the first half of 2024, the Oncology Business Unit optimized its marketing strategies and execution quality despite a shifting competitive landscape and policy environment. While effectively controlling sales expenses, the company generated operating revenue of RMB 80.4934 million yuan in the first half of 2024, with RMB 56.1739 million earned in the second quarter, a 130.98% increase from the previous quarter.

Alongside strong commercialization performance, the Oncology Business Unit is actively preparing for the launch of new products. The new drug application for APL-1706, a diagnostic and management agent for bladder cancer, was accepted in November 2023. Currently, APL-1706 is the world’s only imaging agent approved to assist bladder cancer diagnosis or surgery. It has passed inspection by the Center for Food and Drug Inspection (CFDI), with NMPA approval expected by the end of June 2025.

The Oncology Business Unit is refining a launch plan for APL-1706, exploring opportunities beyond surgical applications, such as outpatient examinations and strategic partnerships. The aim is to broaden market reach and benefit more patients. The team is developing strategies for post-launch access, pricing, expert endorsement, clinical collaboration, and dealer networks.

Additionally, the company will build on its strong brand positioning with a strategy that combines in-house research and in-licensing, will actively pursue external partnerships to further enhance its commercial competitiveness and strengthen its position in oncology.

Commit to Innovation and Drive Pipeline Expansion and Development Worldwide

Guided by its strategy, Asieris has made significant strides in multiple clinical development programs in the first half of the year, with a strong push for global presence.

In the field of women’s health, following the positive results of the international phase III trial for APL-1702 and recognizing the substantial unmet clinical needs, Asieris plans to submit a pre-submission to the European Medicines Agency (EMA) in the fourth quarter of 2024. It also aims to be in discussion with the US Food and Drug Administration (FDA) this year on the design of a pivotal clinical program for the North American market and will apply for a phase III trial in due course. The company has also begun development of the HPV clearance indication.

In the field of genitourinary tumors, the interim analysis for the phase II trial of APL-1202 with tislelizumab for neoadjuvant treatment of muscle-invasive bladder cancer has been completed, thus moving to the next evaluation stage. Data read-out from the phase II trial is expected in September 2024.

The company’s preclinical pipeline includes APLD-2304, AT-014, AT-020, AT-017, AT-018, and AT-021, with active R&D efforts underway. Notably, APL-2302 has advanced to the IND-enabling phase and is expected to receive IND approval within 2024. Compared to major competitors, APL-2302 offers potential advantages such as superior pharmacokinetics, a lower onset dose, and an optimal safety profile, supporting higher safe doses in humans.

Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, "We remain optimistic and confident about the future of Asieris. The launch of our two core products, APL-1702 and APL-1706, is on track and set to address critical unmet medical needs in their respective fields. This progress underscores our commitment to clinical value generation and ensures that patients will soon have access to our innovative products. We also saw strong growth in commercialization, reduced operational costs, and increased efficiency in the first half, showcasing our ability to meet strategic goals. Looking ahead, we will remain focused on genitourinary tumors and women’s health, aiming to deliver even greater value to both society and our shareholders."

On August 28, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported that it has received a patent grant from European Patent Office (EPO) covering the use of modified gamma delta cells for the treatment of cancer and viral indications (Press release, TC Biopharm, AUG 28, 2024, https://www.prnewswire.com/news-releases/tc-biopharm-announces-grant-of-european-patent-covering-use-of-modified-gamma-delta-cells-for-the-treatment-of-cancer-and-viral-indications-302233266.html [SID1234646170]).

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The Company intends to proceed with the patent process in specific European countries in line with the commercial strategy of TCBP.

"We are pleased to further expand our patent portfolio at TCBP with this European patent for Modified Gamma Delta t-cells" said Bryan Kobel, CEO of TC BioPharm. "TCBP continues to focus on our immediate applications for TCB008 while developing future high value gamma delta assets for other indications such as solid tumors. We believe gamma deltas can be a high impact therapeutic when modified with the potential to outpace current CAR and modified t-cells in safety and efficacy, patent protecting these approaches gives us a competitive moat and further value in a potential acquisition scenario."

On August 28, 2024 Akeso, Inc. (9926.HK) reported its interim results, highlighting the Company’s continued innovation and commercial execution (Press release, Akeso Biopharma, AUG 28, 2024, View Source [SID1234646169]). The Company has solidified its lead in cancer immunotherapy bispecific antibodies with the successful market approval of cadonilimab(PD-1/CTLA-4) and ivonescimab(PD-1/VEGF). In the first half of 2024, 4 new drugs were launched, and applications for market approval were submitted for 7 indications across 5 new drugs, and 12 products are in Phase lll clinical trials or commercial stage. Over 20 phase III clinical trials have been completed or are in progress.

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Akeso is propelling forward with innovative therapies to drive global oncology treatment advancements: 6 novel bispecific antibodies have entered clinical trials, and the Company’s first differentiated ADC, AK138D1, is now in clinical development. Upcoming are new drugs featuring ADCs, bispecific ADCs, trispecific antibodies, and other novel targets and mechanisms.

In the first half of the year, Akeso achieved strong commercial growth with innovative drug sales reaching RMB939.4 million, representing an increase of 23.96% for the same period last year. Cadonilimab remained strong and recorded approximately RMB705.7 million, representing an increase of 16.5% for the same period last year, despite having only one 2/3 line cervical cancer indication. Ivonescimab was successfully approved on May 24, 2024 with achieved net product sales exceeding RMB100 million. The Company’s total cash and short-term financial assets, including time deposits, are RMB5.69 billion.

Dr. Michelle Xia, Founder, Chairwoman, President, and CEO of Akeso, said: "In 2024, Akeso has become a major contributor to the field of cancer immunotherapy, outperforming our goals for the year’s first half. The approval of cadonilimab has affirmed our innovative strategy and efficiency in bispecific antibody development, setting a strong foundation for drug commercialization. The success of ivonescimab’s approval further demonstrates our consistent ability to innovate, providing essential support for its international launch and our global drug commercialization efforts.

We’ve launched over 50 clinical trials for combination therapies leveraging the clinical potential of cadonilimab and ivonescimab. Our ongoing exploration includes integrating our two cornerstone bispecific assets with ADCs/bispecific ADCs and innovative treatment approaches for multiple tumor types. This drive will enhance global cancer treatment standards and fuel our sustained, high-quality global expansion over the next five years.

In addition, we’re rapidly advancing research and clinical development across a diverse range of targets including ADCs, bispecific ADCs, tri-specific antibodies, and other innovative therapeutic modalities. Our robust clinical pipeline enhances our product portfolio, maximizes the clinical impact of our key offerings, and establishes a strong base for Akeso’s medium to long-term global growth."

Global Leading Bispecific Antibodies Achieve Major Breakthroughs

Ivonescimab (PD-1/VEGF Bispecific Antibody)

In May 2024, following the HARMONi-A study, ivonescimab was approved in China for the treatment of epidermal growth factor receptor ("EGFR") mutated locally advanced or metastatic non-squamous non-small cell lung cancer ("nsq-NSCLC"). HARMONi-A is the only phase III study that demonstrates significant benefit across all subgroups for PFS, and is also the only study to achieve the primary endpoint while showing a positive trend in OS benefit. Ivonescimab became the world’s first approved PD-1/VEGF bi-specific antibody.

Following the HARMONi-2 study’s positive interim analysis results, which demonstrated that ivonescimab monotherapy decisively beats pembrolizumab monotherapy head-to-head in patients with PD-L1 positive (TPS≥1%) locally advanced or metastatic NSCLC, ivonescimab has been recognized as the only drug to achieve this milestone in this setting. The interim analysis results have led to the NMPA’s priority review of the sNDA for ivonescimab for this indication. The ongoing Phase III studies are strengthening confidence in the HARMONi and HARMONi-3 trials’ outcomes and global market potential.Ivonescimab will become the new standard treatment for first-line lung cancer, offering patients a novel and superior "chemotherapy-free" option.

Currently, ivonescimab has 1 approved lung cancer indication in China, 1 under priority review, and 6 Phase III lung cancer trials completed or ongoing, including 4 head-to-head studies with PD-1. In addition, Akeso has launched or is about to launch 3 Phase III clinical trials for ivonescimab:

Ivonescimab combined with ligufalimab (CD47) for first-line treatment of PD-L1 positive head and neck squamous cell carcinoma (vs. pembrolizumab).
Ivonescimab combination therapy for first-line treatment of biliary tract cancer (vs. durvalumab combination ).
Ivonescimab combination therapy for first-line treatment of pancreatic cancer.
Ivonescimab has been involved in more than 25 clinical trials across 17 indications, including lung, pancreatic, breast, hepatocellular, colorectal, and other cancers.

Cadonilimab（PD-1/CTLA-4 Bispecific Antibody)

Since approval, cadonilimab has received widespread clinical and patient acclaim in cancer immunotherapy, backed by strong clinical evidence. Its role as a cornerstone drug in next-gen immunotherapy is becoming more apparent. Besides its approved use for 2/3 line cervical cancer, submissions for first-line advanced gastric and cervical cancer treatments are under regulatory review. Ongoing Phase III trials reveal substantial benefits for diverse PD-L1 expressing patients, offering new options to address critical unmet need in this patient population.

Additionally, cadonilimab has been involved in 8 ongoing or completed pivotal/Phase III clinical trials: Trials for postoperative adjuvant therapy in hepatocellular carcinoma, intermediate-stage hepatocellular carcinoma, and unresectable NSCLC are swiftly progressing. Trials for gastric cancer that has progressed after PD-1/L1 treatment and first-line treatment for PD-L1 negative NSCLC are also steadily enrolling patients, showcasing cadonilimab’s potential to offer unique clinical advantages and address the limitations of single-target antibody therapies. To date, cadonilimab as a monotherapy or in combination has been engaged in over 23 clinical trials for 16 indications, including gastric, lung, liver, cervical, and pancreatic cancers.

Ligufalimab (CD47 Monoclonal Antibody, AK117)

The Phase III trial of ligufalimab for first-line head and neck squamous cell carcinoma (vs. pembrolizumab) has begun, making it the first CD47 mAb to enter Phase III for solid tumors. The international multi-center Phase II trial of ligufalimab, AK117 for treating myelodysplastic syndromes (MDS) is also underway as part of AK117’s global approval process. Ligufalimab is also being investigated for acute myeloid leukemia (AML), and Phase I/II trials have also been initiated for ligufalimab combined with AK129 (PD-1/LAG-3) in classic Hodgkin lymphoma (cHL). Additionally, several clinical studies for solid tumors are underway.

The Phase III clinical trial for AK109, a novel VEGFR-2 monoclonal antibody, has been initiated in combination with cadonilimab for PD-1/L1-resistant gastric cancer. Clinical trials of other self-developed new drugs in combination with AK109 are also progressing efficiently.

Pursuing More Innovative Therapies

In the first half of the year, Akeso advanced over 10 new therapies into clinical trials, including bispecific antibodies like ivonescimab, cadonilimab, AK129 (PD-1/LAG-3), and AK130 (TIGIT/TGF-β), either in combination with each other or with other high-potential therapies. The Company also introduced its first differentiated ADC product, AK138D1 (HER3 ADC), as well as other innovative therapies into clinical research. Development is ongoing for preclinical candidates such as bispecific antibody AK137 (CD73/LAG-3), bispecific ADC trispecific antibody AK150, and new drug AK135 (IL-1RAP) for chemotherapy-induced peripheral neuropathy. Additionally, multiple candidates in ADC, mRNA, and cell therapies are actively advancing in development.

Non-Oncology Business Enters Commercialization Phase on a Large Scale

Ebdarokimab(IL-12/IL-23) for moderate to severe plaque psoriasis, ebronucimab (PCSK9) for primary hypercholesterolemia and mixed hyperlipidemia, and heterozygous familial hypercholesterolemia (HeFH), have been accepted by NMPA, with anticipated approvals in 2024-2025. Following positive Phase III outcomes, gumokimab (AK111, IL-17) for plaque psoriasis is ready for an NDA submission. Additionally, Phase III trials for gumokimab in ankylosing spondylitis and manfidokimab (AK120, IL-4R) for atopic dermatitis are progressing, with the latter having enrolled its first patient.