Pheast Therapeutics Advances PHST001, an IgG4 Anti-CD24 Monoclonal Antibody, into Phase 1b Combination Cohorts

On March 31, 2026 Pheast Therapeutics, a clinical-stage biotechnology company advancing macrophage-directed immunotherapies for cancer, reported that the first patient has been dosed in the Phase 1b portion of its ongoing Phase 1 study of PHST001, an IgG4 anti-CD24 macrophage checkpoint inhibitor.

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"The initiation of the Phase 1b combination cohorts marks an important step forward for PHST001 and reflects the progress of our Phase 1 program," said Roy Maute, Ph.D., Co-founder and Chief Executive Officer of Pheast Therapeutics. "The safety and biological signals we have seen to-date support advancing PHST001 into combination cohorts with established therapies. Together with the preliminary data we will be presenting at AACR (Free AACR Whitepaper), we are building a strong foundation as we work toward our goal of bringing new options to patients facing cancers with significant unmet need."

The Phase 1b portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PHST001 in combination with established chemotherapy regimens using a suitable dose identified by the Phase 1a portion. To date, the observed safety profile supports continued monotherapy escalation and advancement into combination regimens. Preliminary clinical and translational findings from the Phase 1a portion of the study, along with supporting preclinical data, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22 in San Diego (see company announcement dated March 17, 2026).

Initial expansion cohorts are actively enrolling patients with advanced ovarian cancer, endometrial cancer, and cholangiocarcinoma. Additional tumor types and combination strategies may be explored as the study progresses.

"Advancing into combination therapy allows us to explore how macrophage activation may enhance the activity of existing treatment approaches," said Raphaël Rousseau, M.D., Ph.D., Chief Medical Officer of Pheast Therapeutics. "With a dose established for combination evaluation, Phase 1b enables us to further define the potential role of PHST001 across multiple tumor settings."

PHST001 is designed to block CD24, a macrophage checkpoint that enables tumor cells to evade innate immune clearance through engagement of Siglec-10. By targeting this pathway, PHST001 is intended to promote macrophage-mediated phagocytosis of cancer cells and support anti-tumor immune responses.

About CD24

CD24 is a cell surface protein that plays a key role in tumor immune evasion by engaging Siglec-10, an inhibitory receptor on macrophages. This interaction suppresses macrophage-mediated clearance of cancer cells, allowing tumors to escape destruction by the innate immune system. CD24 was identified as a novel macrophage checkpoint through foundational work by Dr. Amira Barkal, principal founder of Pheast. Along with other co-founders, Drs. Irving Weissman, Ravi Majeti, and Roy Maute, Pheast’s research opened the door to therapeutic strategies targeting CD24 to drive innate immune responses against cancer.

About PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor designed to overcome immune suppression in the tumor microenvironment. CD24 is highly expressed by many human cancers, and high expression of CD24 is a negative prognostic factor in multiple cancer indications. Pheast has engineered PHST001 to be a potential best-in-class antibody designed to induce macrophages to phagocytose cancer cells and initiate a powerful immune response. PHST001-101 is an open-label, multicenter Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT06840886). Primary objectives include safety, tolerability, and dose optimization, with secondary objectives evaluating pharmacokinetics and preliminary anti-tumor activity. PHST001 received FDA Fast Track Designation for the treatment of ovarian cancer in June 2025.

(Press release, Pheast Therapeutics, MAR 31, 2026, View Source [SID1234664105])

NJ Bio, Inc. and Ajinomoto Bio‑Pharma Services Enter into Collaboration to Strengthen Support for Antibody-Drug Conjugate Development

On March 31, 2026 NJ Bio, Inc. ("NJ Bio"), a leading provider of integrated drug discovery and development services and Ajinomoto Bio‑Pharma Services ("Aji Bio‑Pharma"), a leading provider of biopharmaceutical manufacturing services and platform technologies, reported a research collaboration to expand access to AJICAP, Aji Bio‑Pharma’s site‑specific conjugation platform for NJ Bio’s discovery‑stage and early development clients. This collaboration broadens NJ Bio’s advanced antibody conjugation and linker capabilities, supporting the development of next‑generation antibody–drug conjugates (ADCs) and other targeted therapeutics.

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Through the collaboration, NJ Bio will integrate the AJICAP platform into its discovery and development workflows, offering clients a robust and highly reproducible approach for site‑specific conjugation of cytotoxic and non‑cytotoxic payloads to antibodies. AJICAP enables precise chemical modification at defined lysine residues without the need for antibody engineering, preserving antibody structure and functionality while improving pharmacokinetics, therapeutic index, and overall developability. The platform supports a range of stable, hydrophilic linker systems and is readily incorporated into drug discovery and development programs.

AJICAP technology is widely recognized for its scalability, consistency, and compatibility with standard antibody production processes. By integrating this platform, NJ Bio strengthens its position as a comprehensive partner for biopharmaceutical companies seeking end‑to‑end support, from early drug design and discovery through preclinical development.

Clients will benefit from NJ Bio’s deep expertise in medicinal chemistry, bioconjugation, and biologics development, combined with the precision, reproducibility, and flexibility of the AJICAP platform. Based on prior technical experience working with AJICAP technology, NJ Bio anticipates that this collaboration will help reduce development risk, shorten timelines, and improve overall project outcomes.

"Expanding our capabilities with AJICAP aligns strongly with NJ Bio’s mission to deliver cutting-edge, high-value solutions that accelerate our clients’ discovery programs," said Julien Dugal-Tessier, the President and Chief Scientific Officer at NJ Bio. "This collaboration enables us to offer a proven, scalable site-specific conjugation platform, expand access to AJICAP capabilities, and support the development of novel antibody-based medicines with improved efficacy and safety profiles."

"AJICAP was developed to enable precise and scalable antibody conjugation, and we are excited to extend its reach through this collaboration with NJ Bio," said Yasuyuki Otake, Corporate Executive, General Manager, Bio-Pharma Services Dept., Ajinomoto Co., Inc. "Together, we are enhancing the tools available to biopharma innovators to design and develop next-generation targeted therapies for patients."

(Press release, Ajinomoto, MAR 31, 2026, View Source [SID1234664090])

Galapagos and Gilead Enter into Binding Agreement to Collaborate on Advancing First in Class T Cell Engager Program for Autoimmune Diseases

On March 31, 2026 Galapagos NV (Euronext & NASDAQ: GLPG) ("Galapagos" or the "Company") reported that it has entered into a binding agreement (the "Framework Agreement") with Gilead Sciences, Inc. ("Gilead") in connection with Gilead’s definitive agreement to acquire all of the outstanding equity interests of US-based Ouro Medicines, LLC ("Ouro"), a privately held biotechnology company focused on developing T cell engager therapies for autoimmune diseases.

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Gamgertamig (OM336) is a clinical‑stage BCMAxCD3 T cell engager designed to enable rapid and deep plasma and B‑cell depletion following a short duration, subcutaneously administered treatment course. In ongoing Phase 1/2 clinical studies, gamgertamig has demonstrated transformative efficacy and a differentiated safety profile after a single treatment cycle in severe antibody-mediated orphan diseases, including autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP). Gamgertamig has been granted both Fast Track and Orphan Drug Designation by the U.S. FDA for the treatment of AIHA and ITP and is expected to enter registrational studies as early as 2027.

BCMA‑targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. By redirecting a patient’s own T cells toward BCMA‑expressing plasma cells, clinical data suggest these agents can reduce inflammation, improve organ‑level disease, and in some cases enable durable, drug‑free remission without ongoing immunosuppression.

"Today marks an important milestone in the transformation of Galapagos as we are executing on our strategy," said Henry Gosebruch, Chief Executive Officer of Galapagos. "This collaboration brings a clinically meaningful, high‑potential asset into our portfolio, while preserving the majority of our cash for future opportunities. Additionally, the risk-adjusted potential financial return from this collaboration is attractive and leverages our partner’s capabilities. We are pleased to have a cash pool of $500 million that provides greater standalone flexibility, enabling additional strategic transactions and supporting a possible return of up to $150 million capital to shareholders."

Gosebruch continued, "We look forward to welcoming the talented and accomplished Ouro Medicines team to Galapagos and sharing several value enhancing catalysts this year for gamgertamig, as we further advance this potential first-in-class, best-in-class program for patients in indications with high unmet medical need."

"From the outset, we saw the potential for gamgertamig to redefine the standard of care for immune-mediated diseases," said Jaideep Dudani, PhD, Co-Founder and Chief Executive Officer of Ouro Medicines. "Since then, we’ve taken meaningful steps to advance that vision, with multiple trials now underway. With support from Gilead and Galapagos, we can build on the strong early foundation—leveraging its proven track record in late-stage development, launch, and commercialization to accelerate our programs and help deliver on the promise gamgertamig holds for patients with immune-mediated diseases, following our initial collaboration with Keymed Biosciences."

"We are excited about partnering with Galapagos to maintain the momentum that has been generated by the nimble and agile biotech approach to rapidly advance gamgertamig, while leveraging our global commercial capabilities," said Andrew Dickinson, Chief Financial Officer of Gilead.

Terms of the Framework Agreement with Gilead
On March 23, 2026, Gilead announced that it had entered into a definitive agreement to acquire all of the outstanding equity interests of Ouro for a total upfront cash consideration of $1.675 billion, subject to customary adjustments, and up to $500 million in contingent milestone payments (the "Acquisition"). In connection with the Acquisition, the Company has entered into the Framework Agreement with Gilead, which comprises the following components:

relief under the Option, License and Collaboration Agreement dated July 14, 2019 between the Company and Gilead (the "OLCA"), to enable the Company to deploy at least $500 million of its available cash independently from Gilead and outside the scope of the OLCA and the Ouro transaction, including up to $150 million for share buybacks (the "OLCA Waiver");
a binding term sheet granting the Company licenses to certain intellectual property rights relating to Ouro’s research programs, including Ouro’s lead program of gamgertamig for development purposes, and to the BCMAxCD19xCD3 T cell engager program and other preclinical programs for development and commercialization purposes (the "Licensing Term Sheet"); and
a binding term sheet pursuant to which the Company would acquire substantially all Ouro’s operational assets in connection with the Acquisition, including facilities and personnel, such that the Company would obtain an operating business (the "Asset Acquisition Term Sheet").

The Framework Agreement will only come into effect as from the completion of the Acquisition. The parties have agreed to enter into a collaboration agreement consistent with the terms of the binding term sheet.

Financial details of the Framework Agreement
Under the Framework Agreement, the Company’s share of the total consideration for the Acquisition amounts to 50% of the upfront consideration of $1.675 billion and 50% of any contingent milestone payments, which also includes the consideration under the Asset Acquisition Term Sheet.

Under the Licensing Term Sheet, the Company is required to fund its share of payments owed to KeyMed Biosciences Chengdu Co., Ltd ("KeyMed") under the head license agreement between KeyMed and Ouro (the "KeyMed Agreement"), comprising 25% of the milestone payments and 50% of the royalty payments that become due to KeyMed with respect to gamgertamig products. The Company will also bear all costs of development prior to registrational studies for gamgertamig pursuant to agreed-upon research plans and budgets, including Ouro’s current clinical trials, while costs of registration-enabling clinical development would be shared equally between the parties, with execution leadership divided by indication.

Galapagos is also eligible for up to $100 million milestones payments upon Gilead’s initiation of the first registrational trials for gamgertamig in certain other indications.

Gilead will be responsible for commercialization, including all related costs, globally outside of Keymed’s territories. Upon commercialization, Gilead will pay the Company tiered royalties between 20-23% on net sales of gamgertamig.

In addition, Galapagos will gain a preclinical portfolio of three additional autoimmune focused programs originally from Ouro, on which Gilead had the option to opt into a 50/50 profit split post clinical proof-of-concept for $75 million per program.

The OLCA Waiver allows the Company to spend $500 million of cash (and any additional cash generated from that amount) to acquire or develop research programs independently from Gilead and not subject to Gilead’s rights under the OLCA. In addition, the Company can elect to use up to $150 million of that $500 million for potential share repurchases, dividend payments and other distributions of Company’s capital stock, subject to certain limitations.

Related party procedure
Gilead, the counterparty to the Framework Agreement, is a related party to the Company within the meaning of IAS 24. As of December 31, 2025, Gilead Therapeutics A1 Unlimited Company, an indirect wholly-owned subsidiary of Gilead, owned 25.35% of the Company’s shares. Therefore, the Transaction has been subject to the procedure set out in Article 7:97 of the Belgian Code of Companies and Associations ("BCCA").

A committee of three independent members of Galapagos’ Board of Directors (the "Committee") has reviewed the terms and conditions of the Framework Agreement in accordance with the provisions of Article 7:97 of the BCCA and has issued a written, reasoned advice to the Board of Directors. In its advice, the Committee concluded that: "Having regard to the foregoing considerations, the Committee is of the view that the Transaction is not manifestly unlawful in nature and that it is unlikely that the Transaction would result in disadvantages to the Company that are not outweighed by benefits to the Company. The Committee therefore advises favorably on the Transaction." The Board of Directors has, in its decision-making, not deviated from the conclusion of the Committee.

The Company’s statutory auditor has carried out its assessment in accordance with Article 7:97, §4 of the BCCA, the conclusion of which reads as follows: "Based on our review, nothing has come to our attention that causes us to believe that the financial and accounting data reported in the advice of the Committee of independent directors dated on March 30, 2026 and in the minutes of the Board of Directors dated on March 30, 2026, which justify the proposed transaction, are not consistent, in all material respects, compared to the information we possess in the context of our mission. Our mission is solely executed for the purposes described in article 7:97 CCA and therefore our report may not be used for any other purpose."

Advisors
Morgan Stanley & Co., LLC is acting as financial advisor to Galapagos. Paul, Weiss, Rifkind, Wharton & Garrison LLP and Linklaters LLP are serving as legal counsel to Galapagos. The Committee has been assisted by MTS Health Partners, L.P. as independent financial expert to the Committee in connection with the Transaction.

Conference call and webcast presentation:
We will host a conference call and webcast presentation today, March 31, 2026, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call by using the conference access information provided in the email received after registration, or by selecting the "call me" feature. The live webcast is available on www.glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.

About gamgertamig
Gamgertamig (OM336) is an investigational BCMAxCD3 bispecific T-cell engager for the treatment of autoantibody driven autoimmune diseases. It has been granted both Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration for the treatment of autoimmune hemolytic anemia and immune thrombocytopenia purpura. The program is currently under an open Investigational New Drug (IND) in the U.S. and is expected to enter registrational studies in 2027. Gamgertamig is in-licensed by Ouro Medicines from Keymed Biosciences, which owns the rights to develop the program in Greater China.

(Press release, Galapagos, MAR 31, 2026, View Source [SID1234664106])

BioInvent International AB publishes Annual Report 2025

On March 31, 2026 BioInvent reported annual report 2025.

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(Presentation, BioInvent, MAR 31, 2026, https://www.bioinvent.com/sites/bioinvent/files/pr/20260331-2fe033aa-39f5-4c8c-acf3-4f188cfc6620-1.pdf?ts=1774950435 [SID1234669186])

3SBio Announces 2025 Annual Results: Dual Engines of Innovative R&D and Global Collaboration Propel Revenue Past RMB 10 Billion Milestone

On March 31, 2026 3SBio Inc. (01530.HK) reported its 2025 annual results announcement. Fueled by the dual core engines of breakthroughs in innovative R&D and strategic global collaboration, the company delivered a high-quality performance with both quantitative and qualitative growth: annual revenue hit RMB 17.7 billion, a historic breakthrough past the RMB 10 billion mark, representing a 94.3% year-on-year (YoY) increase; net profit attributable to shareholders of the parent company reached RMB 8.48 billion, surging 305.8% YoY; adjusted net profit attributable to shareholders of the parent company stood at RMB 8.45 billion, a 264.6% YoY rise. The company’s profitability achieved a leap-forward growth, demonstrating robust growth momentum.

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In 2025, the company’s R&D expenditure amounted to RMB 1.52 billion, a 14.6% YoY increase, providing solid support for the advancement of its innovative drug pipeline. As of the end of 2025, 3SBio’s total financial resources soared to RMB 20.4 billion, its interest-bearing debt ratio dropped to 9.8%, and comprehensive financial costs contributed a positive RMB 230 million to the company, further optimizing the asset-liability structure. Abundant cash flow and a sound capital structure have fortified the financial foundation for the company’s long-term development. Adhering to its stable dividend policy, the company declared a 2025 final dividend of HKD 0.25 per share, delivering solid shareholder returns to convey confidence in its long-term growth.

During the reporting period, 3SBio entered into a global licensing collaboration with Pfizer with a total deal value of over US$6 billion, receiving an upfront payment of US$1.4 billion and a US$100 million equity investment, setting a new record for the highest upfront payment in a single out-licensing transaction for a Chinese innovative drug. Its core product TPIAO secured approval for a new indication; three novel drugs were successively approved for marketing and three products entered the New Drug Application (NDA) stage. The company has built a multi-domain innovative pipeline matrix, further consolidating its global competitiveness and leading position in core therapeutic areas, and injecting strong impetus into its high-quality development.

I. Groundbreaking Global Collaboration with Pfizer Sets a New Record for Chinese Innovative Drug Out-licensing

2025 marked a pivotal breakthrough in 3SBio’s globalization strategy, as the company entered into a global collaboration with Pfizer for its proprietary PD-1/VEGF bispecific antibody SSGJ-707—a landmark event in China’s biopharmaceutical industry.

Under the collaboration agreement, 3SBio granted Pfizer exclusive global development and commercialization rights to SSGJ-707, with the total potential deal value exceeding US$6 billion. The company is also entitled to tiered double-digit royalties based on the product’s global cumulative sales. The US$1.4 billion upfront payment plus US$100 million equity investment has set a new record for the highest upfront payment in a single out-licensing transaction of a Chinese innovative drug to date. This landmark collaboration not only attests to the high recognition of international pharmaceutical giants for the R&D quality, standards and systems of Chinese innovative drugs, but also fully demonstrates the core global competitiveness of 3SBio and even China’s biopharmaceutical innovation as a whole.

Notably, 3SBio retains the right to supply SSGJ-707 bulk drug substance for clinical and commercial use in China and across the globe. To date, the first batch of SSGJ-707 bulk drug substance for global clinical development has been successfully delivered, marking the official entry of the collaboration into the substantive implementation phase and accelerating the global commercialization progress of the product.

Leveraging Pfizer’s world-class global clinical resources, the global clinical development of SSGJ-707 is progressing at a brisk pace. Nine international multi-center clinical trials have been initiated, covering a broad spectrum of high-incidence tumors including squamous/non-squamous non-small cell lung cancer, metastatic colorectal cancer, extensive-stage small cell lung cancer, gastroesophageal junction cancer, transformed small cell lung cancer, locally advanced/metastatic hepatocellular carcinoma, locally advanced/metastatic urothelial carcinoma, and locally advanced/metastatic renal cell carcinoma. Going forward, the two parties will continue to expand the product’s indications and combination therapy regimens, fully unlocking the global clinical value and commercial growth potential of this core innovative asset.

II. Fruition of Innovation at Scale Builds a New Growth Engine

From 2025 to early 2026, 3SBio entered a period of intensive product approvals. With three novel drugs launched successively, core products gaining new indication approvals, commercialized products included in the National Reimbursement Drug List and authoritative clinical guidelines, and multiple candidates advancing to the NDA stage, the company has accelerated the translation of multi-dimensional innovation value into growth drivers, fueling sustained performance growth.

Three Novel Drugs Approved, Enriching Clinical Treatment Options

Amdokitug Injection (Yisaituo): Approved in February 2026 for the treatment of moderate-to-severe plaque psoriasis. The product features rapid onset of action as early as Week 2, leading PASI100 response at Week 12, and sustained skin lesion clearance at Week 52. It has no neutralizing antibodies detected, with an anti-drug antibody (ADA) rate of only 0.7% and a lower infection risk. A simplified maintenance dosing regimen of once every 8 weeks significantly reduces the annual dosing frequency for patients, alleviating the burden and psychological stress of long-term treatment, and substantially improving treatment adherence.
Loncipoetin Alfa Injection (NuPIAO): Approved in March 2026 as the first domestic long-acting recombinant erythropoietin (EPO) biweekly formulation (a Class 1 innovative drug), indicated for hemodialysis patients with anemia caused by chronic kidney disease who are receiving erythropoietin therapy. Boasting an ultra-long half-life of 120 hours and low immunogenicity, the product is administered intravenously, making it more suitable for hemodialysis patients. Its biweekly dosing regimen drastically cuts down the dosing frequency, significantly improving patient treatment adherence and providing a more convenient therapeutic option for clinical practice.
Eltrombopag Ethanolamine Tablets: Approved in March 2026 for the treatment of immune thrombocytopenia (ITP) and severe aplastic anemia (SAA). The product provides a new oral treatment option for patients with hematological disorders, further improving 3SBio’s commercial product portfolio in the hematology field.
Core Product Expands to New Indication, Unlocking Incremental Market Potential

Recombinant Human Thrombopoietin(TPIAO), the world’s only commercialized recombinant human thrombopoietin product, obtained approval for a new indication in December 2025—for the treatment of chronic liver disease-related thrombocytopenia (CLDT) in patients scheduled to undergo surgery (including diagnostic procedures). This approval provides a rapid-acting, stable and safe platelet-boosting treatment for a large number of perioperative patients with chronic liver disease, further expanding the market coverage of this core product.

Commercialized Product Earns Authoritative Recognition, Accelerating Clinical Penetration

Paclitaxel Oral Solution (Liporaxel) was officially included in the 2025 CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer as a Grade I recommendation (Category 1A) for the second-line treatment of advanced gastric cancer, and was also added to the 2025 National Reimbursement Drug List. Adopting an innovative lipid self-emulsifying drug delivery technology, the product revolutionizes gastric cancer treatment from "hospital-based infusion" to "home-based oral administration", greatly improving medication convenience for patients. Its NDA for the indication of relapsed or metastatic HER2-negative breast cancer has been submitted and accepted, which is expected to further open up its market space.

Three Products in NDA Stage, Delivering Abundant Follow-up Growth Momentum

613 (Anti-IL-1β mAb): Its NDA for acute gouty arthritis was submitted and accepted in June 2025. The biologic penetration rate in China’s acute gout market remains extremely low; as the second domestic product of its class to file an NDA, it enjoys a favorable competitive landscape and is poised to address significant unmet clinical needs with promising market prospects. A Phase II clinical trial for intermittent gouty arthritis is currently underway.
611 (Anti-IL-4Rα mAb): Its NDA for moderate-to-severe atopic dermatitis in adults was submitted and accepted in February 2026. Non-head-to-head comparisons show its overall efficacy is superior to dupilumab. It supports long-acting dosing of once every two or four weeks, delivering stronger efficacy, higher patient adherence and better long-term disease control. Clinical development for additional indications including chronic rhinosinusitis with nasal polyps, chronic obstructive pulmonary disease, and adolescent and pediatric atopic dermatitis is well underway, continuously unlocking the pipeline’s growth potential.
601A (Anti-VEGF mAb): Its NDA for macular edema secondary to branch retinal vein occlusion (BRVO) was accepted in October 2025. The product demonstrates efficacy comparable to ranibizumab, with a favorable overall safety and tolerability profile, providing a new treatment option for ophthalmic clinical practice.
III. Building a Multi-Domain Innovative Pipeline Matrix to Consolidate Long-term Core Competitiveness

In 2025, 3SBio continued to ramp up R&D investment and built a rich and differentiated innovative pipeline matrix focusing on core therapeutic areas including hematology/oncology, autoimmune diseases, nephrology, dermatology, hair disorders and weight management. Multiple products are in key clinical stages with leading-edge target layouts, establishing solid technical and product barriers for the company’s long-term development.

Hematology/Oncology: Multi-pronged Layout of Bispecific/Trispecific Antibodies to Forge Differentiated Competitive Advantages

705 (Anti-PD-1/HER2 BsAb): Currently in Phase II clinical development for HER2-positive advanced solid tumors, it is the only candidate in China actively advancing clinical trials for this target, boasting significant differentiated advantages.
706 (Anti-PD-1/PD-L1 BsAb): Phase II clinical trials for advanced non-small cell lung cancer and advanced gastrointestinal tumors are ongoing, covering high-incidence tumor types with smooth clinical progress.
708 (Anti-PD-1/TGF-β BsAb), 709 (Anti-PD-1/LAG3 BsAb), SSS59 (Anti-MUC17/CD3/CD28 Tri-specific Ab) and SPGL008 (Anti-B7H3 Ab/IL15Rα sushi-IL15 Fusion Protein) for advanced solid tumors are all in Phase I clinical trials; SSS57 (Long-acting ActRIIB-Ig Trap) for myelodysplastic syndrome (MDS)-related anemia is also in Phase I. The hierarchical pipeline layout in hematology/oncology is continuously improved, reserving high-quality assets for the company’s long-term growth.
Autoimmune Diseases: Multiple Products in Key Clinical Stages, Leading Domestic R&D Progress

610 (Anti-IL-5 mAb): Under Phase III clinical development for eosinophilic asthma, it ranks first in China in terms of R&D progress for this target and is poised for early commercialization.
626 (Anti-BDCA2 Ab): Currently in Phase Ib clinical trial for systemic lupus erythematosus (SLE), addressing critical unmet clinical needs in the autoimmune disease field.
627 (Anti-TL1A mAb): Phase II clinical trial for ulcerative colitis (UC) has been initiated, laying out the company’s presence in the core inflammatory bowel disease (IBD) track.
A portfolio of early-stage pipeline assets is advancing rapidly, including 716 (Anti-OX40L/IL-31RA Bispecific Antibody for atopic dermatitis), 717 (CD3/CD19/BCMA for SLE/lupus nephritis/rheumatoid arthritis), 718 (TL1A/IL-23 for IBD), 719 (IL-4R/TSLP for asthma/chronic obstructive pulmonary disease) and 629 (IL-23R for psoriasis/IBD). These candidates fully cover mainstream and cutting-edge targets in the autoimmune disease field, building a deep technical moat for the company.
Nephrology: Focusing on Core Clinical Needs, Pioneering Domestic Layout of Emerging Targets

SSS55 (C3b-targeting Bi-functional Fusion Protein ): Phase I clinical trials have been initiated for paroxysmal nocturnal hemoglobinuria (PNH), complement-mediated kidney disease (CMKD) and periodontitis. 3SBio is the only company in China actively advancing R&D for this target, filling a critical clinical gap in the domestic market.
SSS68 (Long-acting anti-April/BAFF BsAb): Its Investigational New Drug (IND) application for IgA nephropathy has been approved in the US. As the only domestic long-acting bispecific antibody in clinical development targeting the APRIL/BAFF pathway, it features significant differentiated competitive advantages.
Dermatology, Hair Disorders & Weight Management: Forward-looking Layout in High-potential Tracks

WS2403 (Semaglutide Injection): Phase III clinical trials for the weight management indication are currently underway.
WS204 (Clascoterone): Phase III clinical trials for moderate-to-severe acne vulgaris in patients aged 12 and above are currently underway.
SSS67 (Anti-ActRIIA/ActRIIB BsAb): Its IND application for overweight/obesity has been approved in the US. As the only innovative biased bispecific antibody in China to enter the IND stage for this indication, it represents the company’s forward-looking layout in the blue ocean of metabolic disease treatment.
Remarks from Dr. Lou Jing, Chairman and CEO of 3SBio

"2025 marked the conclusion of the 14th Five-Year Plan period. Under the coordinated governance of medical insurance, healthcare and pharmaceuticals, China’s biopharmaceutical industry has witnessed several landmark changes: commercial health insurance has opened up multi-payment channels for innovative drugs, and Chinese innovative drug out-licensing deals have achieved remarkable results. Our proprietary SSGJ-707 set a new record with a 24% upfront payment ratio in its global out-licensing deal, a testament to the global competitiveness of Chinese biopharmaceutical innovation.

In 2026, the biopharmaceutical industry has been designated as a national emerging pillar industry in China. Driven by national policies, the industry is accelerating its transformation from a major pharmaceutical manufacturing country to a global pharmaceutical powerhouse, and 3SBio’s innovation potential has gained wide international recognition.

Building on over 30 years of industry expertise and accumulation, we remain committed to the principle of integrity and innovation. We will continue to deepen our layout in oncology, autoimmune diseases, nephrology and other core therapeutic areas, increase investment in cutting-edge innovation, continuously optimize our R&D pipeline, and accelerate the launch and market promotion of new products such as Liporaxel, Yisaituo and NuPIAO. Guided by our mission to ‘make innovative biopharmaceuticals accessible to all’, we will strive to bring more high-quality innovative drugs to the market at an early date, benefiting patients worldwide."

(Press release, 3SBio, MAR 31, 2026, View Source [SID1234664091])