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Innovent Announces 2025 Annual Results and Business Updates

On March 26, 2026 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic, and other major diseases, reported its 2025 annual results and long-term strategic blueprint.

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Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "2025 marks the most successful year in Innovent’s history. We achieved historic breakthroughs across three areas: business scale, financial strength, and global innovation. We successfully upgraded our strategy from an oncology-focused leader to a ‘dual-engine growth model’ driven by oncology and general biomedicine portfolio.

Encouragingly, we delivered our first full year of net profit, marking a formal entry into an era of sustainable profitability. Our robust cash reserves and positive operating cash flow will provide strong support for strategic growth. On the innovation front, three global high-potential assets advanced into or near global registrational clinical development, targeting a combined addressable market value of over US$60 billion. Meanwhile, we accelerated the global value realization of our pipeline through multiple landmark strategic collaborations, laying a solid foundation for global expansion. Total deal value reached over US$22 billion in the past year, accounting for more than 10% of China’s innovative pharmaceutical sector outbound licensing value in 2025[1].

These achievements not only validate the foresight of our strategy but also highlight our uniqueness of strong growth and high certainty within China’s biopharma industry. Guided by our Vision 2030 to become a global premier biopharmaceutical company, we will continue to drive progress across four core pillars: revenue, profitability, innovative pipeline and organizational capabilities, creating sustainable value for patients, shareholders and society."

Revenue Set New Height, Achieved Full-Year Profitability with Strong Cash Position

Total revenue reached RMB 13.0 billion, representing a year-on-year increase of 38.4%. Product revenue amounted to RMB 11.9 billion, up 44.6% year-on-year. From the commercial launch of its first product in 2019 to 18 approved products and surpassing RMB 10 billion revenue milestone, Innovent accomplished this in only 7 years, setting a new growth benchmark for China’s innovative biopharmaceutical industry.

The Company achieved its first full year of net profit. IFRS net profit reached RMB 814 million, and Non-IFRS net profit rose to RMB 1.72 billion, marking a structural inflection in profitability and entry into a sustainable earnings era.

Operating efficiency continued to improve. Gross margin improved 2.3 percentage points to 87.2%. Selling and administrative expense ratio declined 2.9 percentage points to 48.0%. EBITDA surged to RMB 1.99 billion (2024: RMB 412 million). As of December 31, 2025, cash reserves totaled RMB 24.3 billion (~US$3.5 billion). Additionally, the Company also generated positive operating cash flow, providing strong financial support for long-term development. [2]

Dual-Engine Strategy Fully Implemented, Commercial Foundation Strengthened

China Leading Oncology Brand with Synergistic Value of Innovative Portfolio

Innovent has established a leading oncology brand in China. Cornerstone products including TYVYT (sintilimab injection), BYVASDA (bevacizumab injection) and HALPRYZA (rituximab injection) have benefited millions of Chinese cancer patients.

In addition, five small-molecule targeted oncology drugs—Limertinib (EGFR TKI), DOVBLERON (Taletrectinib, ROS1i), Dupert (fulzerasib, KRAS G12Ci), JAYPIRCA (Pirtobrutinib, BTKi), and Retsevmo (selpercatinib, RETi) — were successfully included in the 2025 National Reimbursement Drug List (NRDL), further strengthening the competitiveness and commercial performance of Innovent’s oncology portfolio.

General Biomedicine Franchise Emerged as a New Growth Engine

Benefiting from forward-looking strategic layout, Innovent’s general biomedicine portfolio delivered strong momentum in 2025.

SYCUME (Teprotumumab, IGF-1R antibody), China’s first innovative therapy for thyroid eye disease in 70 years; Mazdutide, the world’s first and only approved GCG/GLP-1 dual-receptor agonist for obesity and type 2 diabetes; and SINTBILO (tafolecimab injection), the first China-domestic PCSK9 inhibitor included in the NRDL—all exhibited robust performance. PECONDLE (picankibart injection, IL-23p19 antibody), the anchor asset in autoimmune diseases, was also approved at the end of 2025.

Within a single year, the general biomedicine portfolio has become a second core engine driving high-speed growth. Today, Innovent possesses one of the highest-quality commercial portfolio and pipeline in the industry, supported by a fully established commercial network, reinforcing its solid commercial foundation.

Year of Globalization: Pipeline Value Unlocked, Growth Potential Expanded

2025 marked a breakthrough year for the Company’s globalization strategy, unlocking substantial long-term growth potential. Innovent successfully advanced three core assets into or near global Phase 3 clinical trials. According to its partner estimates, these late-stage assets target a combined total addressable market (TAM) of over US$60 billion, including:

IBI363 (PD-1/IL-2α-bias): Next-gen IO cornerstone, potential TAM over US$40 billion for first wave of indications

In collaboration with Takeda, IBI363 is being advanced globally. The first global MRCT Phase 3 in IO-resistant squamous NSCLC has been initiated. PoC in IO-resistant non-squamous NSCLC is completed, with a new global Phase 3 planned subject to the PoC results and regulatory communications. A Phase 3 trial in 3L colorectal cancer (CRC) in China is planned for 2026. A Phase 2 trial in IO-naïve mucosal/acral melanoma is underway in China. PoC studies in 1L NSCLC and 1L CRC are ongoing.
IBI343 (CLDN18.2 ADC): Cornerstone for gastrointestinal cancers, potential TAM over US$8 billion

Interim analysis from the China-Japan Phase 3 clinical trial in 3L gastric cancer is expected in 2026. Phase 3 in 3L pancreatic cancer in China was initiated in 2025. PoC studies in 1L gastric and 1L pancreatic cancer are ongoing.
IBI324 (VEGF/ANG2): Potential best-in-class retinaltherapy, potential TAM US$15 billion

Our partner Ollin Biosciences reported positive top-line results from the Phase 1b JADE head-to-head study against faricimab in wAMD and DME patients in the US. Innovent is working closely with Ollin to engage global regulators in 2026 and advance IBI324 into global Phase 3 trials.
Diversified Partnerships to Accelerate Global Innovation

Total deal value from Innovent’s global collaborations reached over US$22 billion in 2025, representing over 10% of China’s innovative pharma outbound licensing value. These partnerships not only accelerate global pipeline development but also help build core capabilities for Innovent to become a truly world-class biopharma.

With Takeda: Landmark "IO + ADC" collaboration under a co-development and co-commercialization ("Co-Co") model for IBI363 to build its global R&D and commercialization capabilities.
With Eli Lilly: Seventh partnership with an end-to-end innovation model to jointly develop novel oncology and immunology molecules, enhancing full lifecycle R&D frameworks and decision-making from a multinational perspective.
With Roche: Leveraging global oncology resources to advance IBI3009 (DLL3 ADC) worldwide.
With Ollin: Utilizing global ophthalmology expertise to accelerate IBI324’s clinical development and market positioning.
High-Quality Manufacturing Standards

Total operational capacity of 140,000 liters, accounting for 20% of China’s total biologic manufacturing capacity. Site 1 houses 60,000 liters of antibody capacity and ADC commercial lines; Site 2 has 80,000 liters of antibody capacity, supporting global supply and CDMO services.
Sustainable Development and ESG Commitment

8,000 employees worldwide, with global R&D centers in San Francisco Bay Area, Shanghai and Suzhou.
Over 3,000 new cancer patients initiate Innovent therapies daily; more than 6 million patients have benefited to date.
Maintained MSCI ESG AAA rating, leading China’s biopharmaceutical industry.
First innovative biopharma constituent of the Hang Seng Index ("blue-chip" status).
Launched community health initiatives including the MV ‘Weight Management Made Easy’ and documentary ‘Down in Weight, Up in Life’ to promote science-based healthy weight management.
Published patient education materials on thyroid eye disease and weight management to enhance public health awareness.
Implemented multiple patient assistance programs, benefiting over 200,000 patients with drug donations valued at over RMB 3.6 billion.
Received honors including "Healthcare Public Welfare Pioneer" and "China Public Welfare Enterprise".
Created over 2,200 jobs for new graduates.
Cumulative taxes and contributions exceeding RMB 6 billion.
Vision 2030: From China Leader to Global Premier Biopharma

Entering 2026, Innovent celebrates its 15th anniversary. Building on its strong foundation, the Company reaffirms Vision 2030: to evolve into a global premier biopharmaceutical company.

Revenue: Target RMB 20 billion by 2027 with continued expansion thereafter. International revenue will become a new growth driver in the future.
Profitability: Maintain high-quality growth while steadily improving profit margins benchmarking industry-leading levels.
Pipeline: Focus on advancing high-value assets including IBI363, IBI343 and IBI324. Push next-generation oncology and general biomedicine molecules into global early-stage and PoC studies. Target at least 5 molecules in global MRCT Phase 3 by 2030.
Organization: Established a US R&D and operating team of nearly 100 people. Through deep partnerships with Takeda, Lilly, Ollin, Roche and others, Innovent is rapidly building global R&D, regulatory and commercial capabilities. These growing global competencies will further support independent development, enabling Innovent to leap forward into a fully independent, world-class biopharmaceutical enterprise.

(Press release, Innovent Biologics, MAR 26, 2026, View Source [SID1234663957])

Caris Life Sciences Advances Precision Oncology with New AI Insights Predicting Brain Metastases Risk in Breast and Lung Cancer

On March 26, 2026 Caris Life Sciences (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, reported the addition of two new Caris AI Insights signatures included in the Caris Molecular Tumor Board Report. These signatures assess the risk of patients developing brain metastases in breast and lung cancer. The addition of these two signatures brings the total number of proprietary Caris AI insights to seven, providing deeper insights to physicians and patients. This report, available upon request when ordering MI Cancer Seek at no additional cost, provides clinicians with additional insights across all tumor types with specific algorithms for treatment decisions for colon, breast, ovarian, pancreatic and lung cancer.

Caris Life Sciences is accelerating the future of precision oncology by utilizing the world’s most complete multimodal real‑world dataset through its proprietary CodeAI platform, now exceeding over half a million patients tested with Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS), H&E and IHC images with longitudinal follow-up clinical data. The novel Caris signatures for breast cancer and non-small cell lung cancer (NSCLC) predict a patient’s risk of brain metastases. Brain metastases are a common and serious complication for a subset of breast and lung cancer patients, so identifying the risk for this type of complication early is a meaningful step to support more informed clinical decision‑making.

"Insights from these proprietary Caris AI signatures give us a forward-looking view of which patients may be at elevated risk for brain metastases, allowing us to help guide clinicians to shift from passive surveillance to more proactive monitoring," said Caris President David Spetzler, MS, PhD, MBA. "Advanced clinical AI tools like Caris AI Insights are helping future-proof cancer care by integrating molecular intelligence into everyday decision making, so that we can personalize care earlier and with greater precision."

The brain metastases signatures were trained on a large set of 12,994 NSCLC cases and 3,371 breast cancer cases with matched survival outcomes. The signatures generate a personalized predictive score using each patient’s WES and WTS data. Results are visualized as Kaplan‑Meier curves, providing clinicians with an intuitive view of the likelihood and rate of brain metastasis development based on the patient’s molecular profile.

Caris received FDA approval in November 2024 for MI Cancer Seek. This tissue-based assay is the first and only simultaneous WES and WTS-based assay with FDA-approved companion diagnostic (CDx) indications for molecular profiling of solid tumors.

A study is in progress with collaborators of the Caris Precision Oncology Alliance (POA) to highlight how risk prediction for brain metastases in breast and lung cancer patients is achieved using Caris AI Insights. The Caris POA is a global network of leading cancer centers and research groups that collaborate to advance precision oncology and biomarker-driven research.

(Press release, Caris Life Sciences, MAR 26, 2026, View Source [SID1234663956])

C-Ray Therapeutics and SHINE Technologies Enter Strategic Partnership for Exclusive Distribution of No-Carrier-Added Lu-177 in Mainland China

On March 26, 2026 C-Ray Therapeutics (Chengdu, China), a global radiopharmaceutical CRDMO, reported the execution of a Master Radioisotope Supply Agreement with SHINE Technologies, LLC (Janesville, Wisconsin, USA), establishing a long-term, GMP-compliant supply of no-carrier-added lutetium-177 (n.c.a. Lu-177) and granting C-Ray exclusive distribution rights for this critical medical isotope across mainland China — excluding certain pre-existing SHINE partnerships.

Under the agreement, C-Ray will serve as SHINE’s exclusive distribution partner in mainland China, supplying n.c.a. Lu-177 to Chinese radiopharmaceutical developers, biotechnology companies, and healthcare institutions. C-Ray will leverage its integrated, 28,000-square-meter Chengdu facility to provide downstream services including isotope conjugation, fill-and-finish, and quality control — delivering an end-to-end, ready-to-use isotope solution that substantially lowers the barrier for domestic companies to access internationally benchmarked radioisotope supply.

A Critical Isotope, a Strategic Supply

Lu-177 is among the most widely used therapeutic radioisotopes in targeted radiopharmaceutical therapy (TRT) globally, with approved and investigational applications across prostate cancer, neuroendocrine tumors (NETs), and a growing range of oncology indications. Its favorable physical half-life, beta emission energy, and co-imaging capability have made it the cornerstone isotope of the RDC field.

Supply security has long been a practical constraint on pipeline development in China. This partnership addresses that gap directly: SHINE’s Cassiopeia facility — one of North America’s largest n.c.a. Lu-177 production sites — will supply C-Ray under terms meeting both Chinese and U.S. regulatory standards, while C-Ray’s on-the-ground infrastructure ensures reliable last-mile delivery to clients across mainland China.

Leadership Perspectives

"This partnership is a significant step in C-Ray’s strategic supply diversification. Stable, multi-source isotope access is a core competitive advantage for us and our clients. Building on our leadership in Ac-225 supply, securing a reliable, high-quality source of n.c.a. Lu-177 — along with exclusive distribution rights — directly strengthens our clients’ pipeline continuity and reinforces our commitment to building a resilient radiopharmaceutical ecosystem in China. With our integrated platform and deep project management experience, we are confident in our ability to translate premium isotope supply into real patient outcomes and accelerated clinical translation across the industry."
— Haitao Qiao, General Manager, C-Ray Therapeutics

"We are pleased to partner with C-Ray. This partnership reflects SHINE’s ability to serve growing demand for n.c.a. Lu-177 in China while maintaining strong supply for customers in the U.S. and other global markets. By combining C-Ray’s integrated development and manufacturing platform with our large-scale isotope production, we can help advance pipeline innovation and expand patient access to life-saving targeted radioligand therapies."
— Greg Piefer, Founder and CEO, SHINE Technologies

(Press release, C-Ray Therapeutics, MAR 26, 2026, View Source [SID1234663955])

CStone Updated Clinical Progress and Key Phase I/II Data for CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

On March 26, 2026 CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapeutics for oncology, immunology, inflammation, and other key disease areas, reported encouraging clinical progress for CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody.

Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "Based on the latest clinical data for CS2009, we are confident in its potential to transform treatment paradigms across a broad spectrum of tumor types. Driven by its unique molecular design, CS2009 offers key mechanistic differentiation. To date, approximately 200 patients have been enrolled, demonstrating an outstanding safety profile with no observation of the severe toxicities commonly associated with combination regimens containing CTLA-4 and PD-(L)1 inhibitors.

In terms of efficacy, CS2009 has delivered compelling results across multiple indications: as a monotherapy in first-line NSCLC, it achieved an ORR of 90% in patients with PD-L1 TPS ≥ 50%. Significant benefits were also observed in historically difficult-to-treat ‘cold tumors’, including IO-pretreated advanced NSCLC, non-clear cell renal cell carcinoma (nccRCC), and soft tissue sarcoma (STS). Furthermore, Phase II studies evaluating CS2009 in combination with standard chemotherapy for first-line NSCLC, CRC, and other indications have yielded high objective response rates.

We look forward to presenting additional Phase I and Phase II data at this year’s ASCO (Free ASCO Whitepaper) and/or ESMO (Free ESMO Whitepaper) congresses. Currently, we are engaged in advanced partnership discussions with several global multinational pharmaceutical companies and aim to initiate multiple Phase III MRCT by the end of 2026."

Rapid Patient Enrollment with Phase I/II Data Supporting Favorable Safety and Efficacy

The global multi-center Phase I/II clinical trial for CS2009 is actively ongoing in Australia and China, and its Investigational New Drug (IND) application for Phase II has been approved by the U.S. Food and Drug Administration (FDA). As of mid-March 2026, a total of 113 patients with advanced solid tumors have been enrolled in Phase I, with a median follow-up of approximately six months. 85 patients have been enrolled in Phase II.

1. Phase I Data Reinforces an Excellent Safety Profile:

CS2009 demonstrates a favorable safety and tolerability profile across all six dose levels evaluated, with no dose-limiting toxicities (DLTs) observed and the maximum tolerated dose (MTD) not reached.
The incidence of Grade ≥3 TRAEs was 23%; Grade ≥3 immune-related adverse events (irAEs) was 12.4%; and Grade ≥3 VEGF-related TRAEs was 4.4%. No excessive toxicities that typically occurred in combination therapies containing CTLA-4 and PD-(L)1 were observed.
2. Broad Antitumor Activity Observed in Heavily-Pretreated NSCLC and "Cold Tumors":
Antitumor activity was observed across all dose levels, with robust efficacy signals in multiple tumor types.

At the 30 mg/kg, Q3W, CS2009 monotherapy achieved an ORR of 25% (6/24) and a DCR of 58.3% (14/24) in AGA-negative, later-line NSCLC patients.
Across dose levels, CS2009 monotherapy resulted in an ORR of 40% and a DCR of 100% in patients with nccRCC (n=5).
Across dose levels, CS2009 monotherapy resulted in an ORR of 33.3% and a DCR of 66.7% in patients with STS (n=9).
Phase II Data Reveal Transformative Potential of CS2009: 90% ORR with Monotherapy in First-Line NSCLC and Excellent Tolerability in Combination Regimens for First-Line NSCLC and CRC

The global multi-center Phase II clinical trial employs a multi-cohort parallel expansion design to evaluate the efficacy and safety of CS2009 monotherapy and combination therapy across 15 cohorts in 9 solid tumor types, including NSCLC, CRC, extensive-stage small cell lung cancer (ES-SCLC), cervical cancer (CC), gastric or gastroesophageal junction cancer (GC/GEJC), esophageal squamous cell carcinoma (ESCC), platinum-resistant ovarian cancer (PROC), triple-negative breast cancer (TNBC), and hepatocellular carcinoma (HCC).

1. Monotherapy Shows Striking Efficacy in First-line NSCLC:
CS2009 monotherapy (20 mg/30 mg, Q3W) achieved an ORR of 90% (9/10) and a DCR of 100% (10/10) in first-line NSCLC patients with PD-L1 TPS≥50% (n=10).

2. Combination Therapies Demonstrate Favorable Tolerability and Promising Efficacy
Safety data from multiple cohorts of CS2009 combined with standard chemotherapy showed that the combinations were well-tolerated across tumor types, with CS2009 without increasing the incidence or severity of chemotherapy-related adverse events. Initial potent antitumor activity was observed with combination treatment in first-line NSCLC and first-line CRC.

Efficient and Clearly-Defined Global Development Strategy

CStone plans to initiate the first set of Phase III global MRCTs for CS2009 by the end of 2026, focusing on indications including NSCLC, CRC, and SCLC.

Additional Phase I and Phase II clinical data for CS2009 are expected to be presented at the 2026 ASCO (Free ASCO Whitepaper) and/or ESMO (Free ESMO Whitepaper) Annual Meetings.

About CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody)

CS2009, an innovative trispecific antibody designed and developed by CStone, with the potential to be first- or best-in-class. It combines three clinically validated targets—PD-1, VEGFA, and CTLA-4—and exerts multidimensional antitumor effects through synergistic actions. Specifically, anti-PD-1 activity reverses T cell exhaustion, anti-CTLA-4 activity promotes T cell activation and proliferation, while anti-VEGFA activity blocks tumor angiogenesis and improves the tumor micro-environment (TME). In the TME, anti-PD-1 and anti-CTLA-4 activities are significantly enhanced by crosslinking with VEGFA. Meanwhile, CS2009 preferentially blocks PD-1 and CTLA-4 on double-positive tumor-infiltrating T cells while minimizing interference with CTLA-4 regulation in peripheral T cells.

(Press release, CStone Pharmaceauticals, MAR 26, 2026, View Source [SID1234663954])

Keymed Biosciences Announces 2025 Annual Results and Business Updates

On March 26, 2026 Keymed Biosciences (HKEX: 02162) reported its 2025 annual results. The year marked the company’s 10th anniversary and a pivotal year in its transition from R&D to commercialization.

Revenue Leaps Forward, Supporting Long-Term Stable Growth

Since its founding in 2016, Keymed has built a pipeline of over 50 programs, with more than 10 in clinical development, three indications successfully launched, six core technology platforms continuously upgraded, over 10 external partnerships established, and planned production capacity exceeding 100,000 liters.

In terms of financial performance, the company achieved a significant revenue increase. Total revenue in 2025 was approximately RMB 720 million, a 67% year-on-year increase. This included around RMB 310 million from sales of the core product Kangyueda and approximately RMB 410 million from collaboration income. The company maintained steady R&D investment, with R&D expenses of approximately RMB 720 million. As of December 31, 2025, cash reserves stood at approximately RMB 1.96 billion, providing ample funding to support core pipeline development and long-term business growth.

Core Product Commercialization in Full Swing, Continuous Expansion of Indication Footprint

As of the date of this announcement, the new drug applications of Kangyueda for the treatment of moderate-to-severe atopic dermatitis (AD) in adults, chronic rhinosinusitis with nasal polyps (CRSwNP) and seasonal allergic rhinitis (SAR) have been approved by the National Medical Products Administration (NMPA). Since January 2026, all launched indications of Kangyueda and both of its packaging forms (vials and pre-filled auto-injector pens) have been included in the National Reimbursement Drug List of China, significantly enhancing affordability and accessibility for Chinese patients.

During the Reporting Period, revenue for sales of Kangyueda amounted to approximately RMB310 million. In January 2026, the new drug applications for Stapokibart for the treatment of adolescents with moderate-to-severe AD were accepted by the NMPA. Simultaneously, we are advancing a Phase III clinical study to evaluate the efficacy and safety of Stapokibart in child subjects with moderate-to-severe AD, and as of the date of this announcement, patient enrollment is in progress. Additionally, in 2025, we continuously proceeded with a Phase III clinical study of Stapokibart injection in patients with prurigo nodularis (PN). This clinical study has completed the patient enrollment in April 2025.

Global Partnerships Accelerate, Milestone Payments Validate Pipeline Value

In 2025, the company advanced several core pipeline programs through out-licensing deals, accelerating clinical development and unlocking overseas value for early-stage assets at an accelerated pace. Multiple business development achievements continued to validate the company’s platform innovation potential and diverse partnership model, providing sustained momentum for subsequent in-house R&D and pipeline advancement.

CMG901 (AZD0901, Claudin 18.2 ADC), a first-in-class Claudin 18.2 ADC globally, has received Fast Track and Orphan Drug Designations from the FDA, as well as Breakthrough Therapy Designation from the CDE. Following its out-licensing to AstraZeneca for global development, multiple global Phase III clinical trials are being rapidly advanced. In February 2026, the first subject was dosed in this clinical trial, triggering a milestone payment subject to the terms and conditions of the license agreement. In early March 2026, KYM Biosciences Inc. (a 70% non-wholly-owned subsidiary of the Group) received the relevant milestone payment totaling US$45 million.
CM336 (BCMA x CD3 bispecific antibody) was out-licensed to Ouro Medicines for global development (excluding Greater China). Open-label, multi-country basket studies are underway in the United States and Australia for relapsed/refractory autoimmune hemolytic anemia (AIHA), primary immune thrombocytopenia (ITP), and other autoimmune cytopenias, with the first cohort of patients having completed dosing. Basket studies have also been initiated for active, autoantibody-positive Sjögren’s syndrome and idiopathic inflammatory myopathy. In January 2026, CM336 was granted Fast Track Designation (FTD) by the FDA for the treatment of AIHA and ITP.
In March 2026, Ouro Medicines announced that Gilead Sciences would acquire Ouro Medicines through a merger. The Merger Agreement provides for an upfront payment at Closing of US$1,675 million, subject to customary adjustments, and contingent milestone payment of up to US$500 million, for a maximum total of US$2,175 million. It is expected that based on the Company’s equity interest in Ouro Medicines, the Group will receive an initial payment of approximately US$ 250 million, and contingent milestone payment of up to approximately US$ 70 million, for a maximum total of approximately US$320 million. The final consideration receivable by the Group is subject to the achievement of relevant milestones as well as the shareholders agreement amongst the Ouro Medicines shareholders.

CM355 (CD20 x CD3 bispecific antibody) : In January 2025, the company entered into a license agreement with Prolium, granting exclusive rights for global development in non-oncology indications and for oncology indications outside Asia. Keymed and its partner InnoCare received a combined upfront and near-term payment of $17.5 million, and are eligible for milestone payments and tiered royalties totaling up to $502.5 million, as well as a minority equity interest in Prolium. As of the date of this announcement, Prolium announced the initiation of dosing in healthy subjects in a single dose-escalation study of CM355/PRO-203, and expects to initiate an international multi-center Phase I/II clinical study for the treatment of systemic sclerosis (SSc) in the second quarter of 2026, and will also initiate therapeutic studies for other B-cell-driven severe autoimmune diseases within 2026. Additionally, in an investigator-initiated exploratory study, 5 patients with refractory advanced systemic lupus erythematosus (SLE) (all accompanied by lupus nephritis) are undergoing treatment evaluation.
CM313 (CD38 antibody) : In January 2025, the company entered into an exclusive license agreement with Timberlyne Therapeutics for global development (excluding Greater China), receiving $30 million in upfront and near-term payments, and became the largest shareholder of Timberlyne.
Promising Pipeline Data Highlights Best-in-Class Potential

CM512 (TSLP x IL-13 bispecific antibody) : The Phase I study has met all study endpoints. Data showed a half-life of up to 70 days, supporting the potential for extended dosing intervals. Notably, 50% of patients in the 300 mg group achieved EASI-75 at Week 6 post-first dose, compared to 7% in the placebo group. At Week 12, EASI-75 and EASI-90 response rates in the 300 mg dose group reached 58.3% and 41.7%, respectively, versus 21.4% and 0% in the placebo group. At Week 24, response rates remained stable across all endpoints and were significantly superior to placebo. Multiple Phase II studies for CM512 have been initiated across indications including chronic rhinosinusitis with nasal polyps (CRSwNP), moderate-to-severe atopic dermatitis (AD) in adults, moderate-to-severe asthma, moderate-to-severe chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria (CSU). Notably, the Phase II study in CRSwNP has completed enrollment of 120 target patients.
CM336 (BCMA x CD3 bispecific antibody) : Data from the Phase II dose-expansion cohort in relapsed/refractory multiple myeloma (RRMM) showed an objective response rate (ORR) of 95.2% in the target dose group, with a ≥ complete response (≥CR) rate of 76.2%, a minimal residual disease (MRD) negativity rate of 100%, and a 12-month progression-free survival (PFS) rate of 95.2%. The Phase III study was initiated in the second half of 2025.
In 2025, we continuously proceeded with a Phase I/II clinical study to assess CM336 injection for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). As of July 2025, in the Phase II dose-expansion stage, only 4.7% of subjects experienced Grade 2 cytokine release syndrome (CRS) events, with no immune effector cell-associated neurotoxicity syndrome (ICANS) events occurring. The objective response rate (ORR) in the target dose group was 95.2%, the rate of complete response (CR) or better was 76.2%, the minimal residual disease (MRD) negativity rate was 100%, and the 12-month progression-free survival rate was 95.2%. Concurrently, in the second half of 2025, we initiated a Phase III clinical study to evaluate CM336 monotherapy versus investigator’s choice (standard of care, SOC) in RRMM patients who previously have received at least second-line treatment.

Other Pipeline Programs Progressing Steadily:

CM518D1 (CDH17 ADC) : Initiated a Phase I/II clinical trial for advanced solid tumors.
CM383 (Aβ protofibril antibody) : Completed patient enrollment in a Phase Ib study for Alzheimer’s disease.
CM559 (N3pG Aβ antibody): A Phase I clinical study in healthy male subjects for the treatment of early Alzheimer’s disease was initiated in 2025, with the first subject enrolled in September.
CM326 (TSLP antibody) : Led by CSPC Pharmaceutical Group, clinical studies for multiple indications are underway. A Phase III clinical study for moderate-to-severe asthma completed enrollment of the first subject in March 2026, and a Phase III clinical study for CRSwNP was initiated in February 2026.
CM350 (GPC3 x CD3 bispecific antibody) : Phase I/II study in advanced solid tumors is in dose-escalation phase.
CM369/ICP-B05 (CCR8 antibody) : Phase I dose-escalation trials continue in advanced solid tumors and relapsed/refractory non-Hodgkin lymphoma.
Innovative Technology Platforms Continue to Evolve, Forward-Looking Positioning in Chronic Disease

The company has established a diverse set of technology platforms, including Antibodies Discovery Platform, KeyMedSTAR (Keymed Superior Topo1i ADC Reagents) ADC Platform, TCE Bispecific Antibodies Platform, VESIR (VEhicle for siRNA Delivery) Oligonucleotide Platform, Small Molecule Platform and KeyCND (Keymed Central Nervous System Delivery) – Blood-Brain Barrier-Penetrating Antibody Delivery Platform. Leveraging iterative and synergistic platform innovation capabilities, the company continues to efficiently generate high-quality, high-potential innovative medicines, pioneering a blue ocean in the broader chronic disease treatment landscape.

Talent and Organization Continuously Optimized, High-Standard Capacity Development Accelerates

As of December 31, 2025, the company had 1,625 full-time employees, including a commercialization team of over 400 and a drug discovery and clinical operations team of over 430, providing strong talent support for product commercialization and R&D. The Chengdu manufacturing facility currently has three pilot production lines and three commercial production lines, achieving a total capacity of 21,800 liters. A newly added 24,000-liter stainless steel production line has completed installation and commissioning and is about to come into operation. All facilities are designed in compliance with NMPA and FDA cGMP standards, with total planned capacity exceeding 100,000 liters in the future.

The 2025 annual results comprehensively demonstrate the company’s transformative progress in proprietary R&D, clinical advancement, and commercial operations, as well as its broad prospects across diversified technology platforms, innovative partnership-driven global expansion, and value realization on the world stage, underscoring the sustained and steady momentum fueled by original innovation. Keymed will continue to uphold its "patient-centric" philosophy, address unmet clinical needs, and remain committed to proprietary R&D and differentiated innovation, delivering high-quality, affordable innovative therapies to patients, while creating sustainable, long-term value for shareholders, partners, and society.

(Press release, Keymed Biosciences, MAR 26, 2026, View Source [SID1234663953])