This week’s China healthcare highlights include Eli Lilly’s partnership with Zonsen PepLib for peptide drug discovery, PrimeGene’s Hong Kong IPO for its JAK inhibitor, and Eisai’s US$ 388M licensing deal with Henlius for anti-PD-1 therapy Hetronifly. Sanegene Bio announced a US$ 1.7B RNAi collaboration with Genentech, while WuXi Biologics and Vertex advanced trispecific T-cell engagers for autoimmune diseases. Key clinical milestones include Henlius’ EU approval for serplulimab in ES-SCLC, Leaderna’s IND approval for siRNA obesity drug LDR2515, Ascentage’s clearance for BTK degrader APG-3288, Everest’s etrasimod NMPA approval for ulcerative colitis, and Akeso’s ivonescimab receiving its fifth breakthrough therapy designation for BTC. These developments underscore China’s growing innovation in drug development, regulatory approvals, and global collaborations.

Transactions

Eli Lilly (NYSE: LLY) Partners with Zonsen PepLib Biotech for Peptide Drug Discovery

Key Words: Eli Lilly, Zonsen PepLib, peptide drug discovery, peptide library, IND-enabling studies, radioligand therapy

The News: Zonsen PepLib has entered into a global research collaboration and license agreement with Eli Lilly to discover and develop novel peptide drug candidates. Under the agreement, PepLib will utilize its proprietary peptide library and discovery platform to identify and optimize lead molecules. Eli Lilly will take responsibility for IND-enabling studies, as well as clinical development and commercialization. PepLib will receive an upfront payment and is eligible for development, regulatory, and sales milestone payments, in addition to tiered royalties.

Key Highlights:

• PepLib’s Discovery Platform:
  • Leveraging a proprietary and diversified peptide library for drug discovery and optimization.
  • Focused on advancing lead molecules with potential for global applications.
• Eli Lilly is responsible for preclinical and clinical development, as well as global commercialization of resulting assets.
• Continued Momentum for PepLib:
  • In January 2026, PepLib licensed global rights to a peptide-based radioligand therapy asset to Novartis.
  • Consecutive partnerships with leading pharmaceutical companies validate PepLib’s platform and strategy of advancing innovation through external collaborations.

PrimeGene Files for Hong Kong IPO with First-in-Class Topical JAK Inhibitor

Key Words: PrimeGene, Hong Kong IPO, pumecitinib, JAK inhibitor, atopic dermatitis, allergic rhinitis, immune-inflammatory diseases

The News: China-based biotechnology firm PrimeGene has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange (HKEX). Established in 2016, the company specializes in immune-inflammatory diseases, with a focus on locally delivered targeted therapies. Its lead asset, pumecitinib, a JAK1/JAK2 inhibitor, is being developed in gel and nasal spray formulations for different indications.

Key Highlights:

• Pumecitinib Development:
  • The gel formulation, targeting atopic dermatitis, has successfully completed a Phase III trial. PrimeGene plans to submit a new drug application (NDA) in Q1 2026.
  • The nasal spray formulation, developed for seasonal allergic rhinitis, is in Phase III trials, with an NDA submission expected by Q4 2026.
• PrimeGene’s pipeline includes additional first-in-class candidates targeting unmet needs in immune-inflammatory diseases, positioning the company as a leader in locally delivered targeted therapies.
• PrimeGene reported R&D expenses of approximately RMB 97 million for the first nine months of 2025, highlighting its ongoing investment in innovation.

Eisai (4523.T) Secures US$ 388M Deal for Japanese Rights to Henlius’ (2696.HK) Anti-PD-1 Therapy Hetronifly

Key Words: Eisai, Henlius, Hetronifly, PD-1, serplulimab, ES-SCLC, oncology licensing

The News: Eisai has entered a licensing agreement worth up to US$ 388 million with Shanghai Henlius Biotech for the Japanese rights to Hetronifly (serplulimab), a differentiated anti-PD-1 monoclonal antibody (mAb). Under the agreement, Eisai will pay US$ 75 million upfront for the rights to develop and commercialize Hetronifly in Japan. Henlius is also eligible for up to US$ 80 million in regulatory milestones, US$ 233 million in sales milestones, and double-digit royalties on net sales.

Key Highlights:

• Hetronifly Overview:
  • Approved in China for multiple solid tumour indications.
  • Recently recommended by the European Commission as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) when combined with carboplatin and etoposide.
  • Holds the distinction of being the first anti-PD-1 therapy globally approved for frontline ES-SCLC.
• Development Plans in Japan:
  • Henlius is conducting a Phase II ES-SCLC bridging trial in Japan and plans to submit a new drug application in 2026.
  • Additional clinical trials are planned for perioperative gastric cancer in Japan, with Henlius serving as the marketing authorization holder.

Sanegene Bio Enters US$1.7 Billion RNAi Drug Development Collaboration with Genentech  

Key Words: Sanegene Bio, Genentech, RNAi, siRNA, drug development, US$1.7 billion deal, LEAD delivery technology

The News: Sanegene Bio, a clinical-stage biotechnology company specializing in RNA interference (RNAi) therapeutics, has announced a global research collaboration and licensing agreement with Genentech, a subsidiary of Roche. Under the agreement, Sanegene will grant Genentech the exclusive worldwide rights to develop and commercialize a novel RNAi therapy.

Sanegene will receive US$ 200 million in upfront payments and is eligible for up to US$ 1.5 billion in development and sales milestone payments, as well as tiered royalties. While Sanegene will lead early-stage development, Genentech will assume responsibility for global clinical development and commercialization.

Key Highlights:

• Strategic Collaboration:
  • The partnership leverages Sanegene’s proprietary RNAi drug development platform, which features innovative chemical modifications and tissue-targeting delivery technologies.
  • The platform enables the development of potentially breakthrough siRNA therapies across multiple disease areas.
• Sanegene Bio will receive a US$ 200 million upfront payment and is eligible for up to US$1.5 billion in development and sales milestone payments, along with tiered royalties on future product sales.
• Sanegene Bio, founded in 2021 and led by RNAi pioneers, focuses on developing “best-in-class” and “first-in-class” RNAi therapies. With R&D centers in Suzhou, Shanghai, and Boston, the company targets immune-mediated diseases, obesity, and cardiovascular/metabolic disorders, leveraging its proprietary LEAD™ delivery platform and advancing five clinical-stage programs.

WuXi Biologics (2269.HK) and Vertex (VRTX.O) Partner on Trispecific T-cell Engager for Autoimmune Diseases

Key Words: WuXi Biologics, Vertex Pharmaceuticals, T-cell Engager, trispecific TCE, autoimmune diseases, CRDMO

The News: WuXi Biologics has announced a license and research service agreement with Vertex Pharmaceuticals to advance a preclinical trispecific T-cell Engager (TCE) targeting B-cell mediated autoimmune diseases. Under the agreement, Vertex will obtain exclusive global rights to develop and commercialize the TCE program.

Key Highlights:

• WuXi Biologics will receive an upfront payment and is eligible for development, regulatory, and sales milestone payments, as well as royalties on future sales.
• In addition to the TCE program licensing, WuXi Biologics will provide Vertex with contract research and development services for next-generation TCEs, supported by WuXi’s integrated discovery and development platforms under its CRDMO model.

Clinical

Henlius’ (2696.HK) Serplulimab Approved in EU as First Anti-PD-1 Therapy for ES-SCLC

Key Words: Henlius, Serplulimab, Hetronifly, ES-SCLC, PD-1, EU approval, ASTRUM-005

The News: Henliu has announced that its anti-PD-1 monoclonal antibody (mAb) serplulimab, marketed as Hetronifly® in Europe, has been approved by the European Commission (EC) as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide. This makes serplulimab the first and only anti-PD-1 mAb approved in the European Union (EU) for ES-SCLC.

Key Highlights:

• Global First:
  • Serplulimab is the world’s first anti-PD-1 mAb approved for first-line ES-SCLC treatment.
  • The approval was based on data from the ASTRUM-005 Phase III trial, which enrolled 585 patients across multiple countries.
• European Expansion: The approval spans all 27 EU member states and European Economic Area countries, with commercialization in Europe to be managed by Accord Healthcare, a subsidiary of Henlius’ partner, Intas Pharmaceuticals.
• Henlius is currently conducting a U.S. bridging trial comparing serplulimab with atezolizumab to support its FDA submission, while its manufacturing facilities in Shanghai, which have passed EU GMP inspections, ensure a stable supply for the European market.

Leaderna Therapeutics Receives IND Approval in China for siRNA Obesity Drug LDR2515

Key Words: Leaderna Therapeutics, LDR2515, siRNA, obesity, IND approval, China, NMPA

The News: Leaderna, a biotech company based in Chengdu, China, has received implied approval from the National Medical Products Administration (NMPA) for the clinical trial application (IND) of its siRNA drug, LDR2515, for the treatment of obesity. The Phase I clinical trial will be conducted at Chengdu Third People’s Hospital and is designed as a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of LDR2515 in healthy subjects and obese patients.

Key Highlights:

• LDR2515 targets the INHBE gene, which primarily expresses Activin E protein in the liver, promoting lipid accumulation. Genomic studies show that loss-of-function mutations in INHBE improve waist-to-hip ratio, reduce abdominal fat, and lower the risk of metabolic disorders, cardiovascular diseases, and type 2 diabetes.
• Preclinical studies demonstrated LDR2515’s ability to reduce weight sustainably in obese mice without affecting food intake. When combined with GLP-1 receptor agonists, it enhances weight loss, mitigates muscle loss, and prevents weight regain after GLP-1 therapy discontinuation.
• LDR2515 is a subcutaneous injection designed to efficiently and sustainably suppress liver INHBE expression. It is expected to enable dosing once every six months to a year, offering a novel approach to high-quality weight loss and metabolic health.
• About Leaderna Therapeutics: Founded in 2022 by former executives of publicly listed companies and internationally recruited talents, Leaderna Therapeutics focuses on oligonucleotide drug innovation and development. The company has established robust platforms for small RNA modification, extrahepatic delivery, and dual-target interference. Its pipeline targets metabolic and cardiovascular diseases with the aim of developing best-in-class and first-in-class oligonucleotide therapeutics.

Ascentage Pharma (AAPG.O; 6855.HK) Secures IND Clearance in China for BTK Degrader APG-3288

Key Words: Ascentage Pharma, APG-3288, BTK degrader, IND clearance, hematologic malignancies, Phase I trial, China CDE

The News: Ascentage Pharma announced that its next-generation Bruton’s tyrosine kinase (BTK) degrader, APG-3288, has received Investigational New Drug (IND) clearance from the China Center for Drug Evaluation (CDE). This clearance follows an earlier IND approval by the U.S. Food and Drug Administration (FDA) and marks a significant milestone for the global clinical development of APG-3288. The IND will allow Ascentage Pharma to initiate a multicenter Phase I clinical study of APG-3288 in patients with relapsed/refractory hematologic malignancies.

Key Highlights:

• Phase I Study: The trial will be a multicenter, open-label study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of APG-3288 in patients with relapsed/refractory B-cell malignancies.
• BTK and APG-3288:
  • BTK is a critical kinase in the B-cell receptor (BCR) signaling pathway and is implicated in the progression of B-cell malignancies such as diffuse large B-cell lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia (CLL).
  • APG-3288, developed using Ascentage Pharma’s proprietary PROTAC technology, selectively degrades wild-type and mutant BTK proteins, addressing resistance to conventional BTK inhibitors.
• Unlike traditional BTK inhibitors, APG-3288 works through proteasome-mediated degradation, offering a novel mechanism of action to overcome resistance and providing a differentiated strategy for BTK-targeted therapies.

Everest Medicine (1952.HK) Announces NMPA Approval of Etrasimod for Ulcerative Colitis

Key Words: Everest, etrasimod, NMPA approval, ulcerative colitis, ENLIGHT UC, ELEVATE UC, China

The News: Everest announced that China’s National Medical Products Administration (NMPA) has approved etrasimod for the treatment of adult patients with moderate to severe active ulcerative colitis (UC). The approval is for patients who have responded inadequately to, lost response to, or are intolerant of conventional therapies or biologics.

Key Highlights:

• The approval was supported by positive results from the Asian Phase III ENLIGHT UC study, which demonstrated statistical significance and clinical relevance across all primary and secondary efficacy endpoints, along with a favorable safety profile.
• Additional data from the global Phase III ELEVATE UC studies (ELEVATE UC 52 and ELEVATE UC 12) also confirmed efficacy and safety, meeting all primary and key secondary endpoints.
• Etrasimod is recommended as a first-line treatment for UC in international guidelines, highlighting its potential as a key therapeutic option for patients.

HighTide (2511.HK) Completes Phase IIb Study of HTD1801 for MASH

Key Words: HighTide, HTD1801, MASH, Phase IIb, CENTRICITY study, liver disease, FDA consultation

The News: HighTide Therapeutics announced the completion of the global multicenter Phase IIb clinical trial (CENTRICITY study, NCT05623189) for HTD1801 in patients with metabolic dysfunction-associated steatohepatitis (MASH) and Type 2 diabetes (T2DM) or prediabetes.

Key Highlights:

• The CENTRICITY trial evaluated HTD1801 against placebo, with an initial analysis revealing a 48% placebo effect in NAS reduction or MASH resolution without fibrosis worsening, much higher than the typical 20% placebo effect observed in similar studies.
• Further analysis identified issues such as co-medication management and patient compliance that may have influenced results. After excluding these factors, the placebo effect decreased, and HTD1801 demonstrated improved efficacy trends across multiple liver histological indicators.
• HTD1801 maintained consistent long-term safety and tolerability throughout the study.

Sichuan Kelun’s (6990.HK, 002422.SZ) Sacituzumab Tirumotecan Receives NMPA Approval for Fourth Indication

Key Words: Sichuan Kelun, sacituzumab tirumotecan, SKB264, Acele®, HR+/HER2- breast cancer, NMPA approval, Phase 3

The News: Sichuan Kelun Pharmaceutical announced that its subsidiary, Sichuan Kelun Botai Biological Medicine Co., Ltd., has received approval from China’s National Medical Products Administration (NMPA) for sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870, branded as Acele®) for its fourth indication. The approval is for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer who have previously received endocrine therapy and at least one line of chemotherapy in the advanced setting.

Key Highlights:

• The approval was supported by data from the OptiTROP-Breast02 Phase 3 study, which showed a significant improvement in progression-free survival (PFS) assessed by BIRC for sac-TMT compared to chemotherapy (8.3 months vs. 4.1 months; HR: 0.35; p<0.0001).
• PFS benefits were consistent across all pre-defined subgroups. The drug also demonstrated a trend toward improved overall survival (OS) and significantly increased overall response rate (ORR: 41.5% vs. 24.1%).

Akeso’s (9926.HK) Ivonescimab Receives Fifth Breakthrough Therapy Designation for Advanced BTC

Key Words: Akeso, ivonescimab, Breakthrough Therapy Designation, BTC, PD-1, VEGF, Phase III

The News: Akeso announced that ivonescimab, its first-in-class bispecific antibody targeting PD-1 and VEGF, has been granted its fifth Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA). This latest designation applies to ivonescimab combined with chemotherapy as a first-line treatment for advanced biliary tract cancer (BTC).

Key Highlights:

• The Phase 1b/II study, presented at the 2024 ASCO Annual Meeting, reported an Objective Response Rate (ORR) of 63.6% and a Disease Control Rate (DCR) of 100%. Median Progression-Free Survival (mPFS) was 8.5 months, and Median Overall Survival (mOS) reached 16.8 months, demonstrating the potential of ivonescimab in advanced BTC.
• Phase III Study: A randomized, controlled, registrational Phase III trial (AK112-309/HARMONi-GI1) comparing ivonescimab plus chemotherapy to durvalumab plus chemotherapy has completed patient enrollment.
• This designation underscores ivonescimab’s promising clinical profile and is expected to accelerate its development and regulatory review. Ivonescimab has already received four prior BTDs in lung cancer and triple-negative breast cancer, highlighting its broad therapeutic potential across high unmet need indications.
• About Akeso: Founded in 2012, Akeso is a leading biopharmaceutical company with a robust pipeline of over 50 innovative assets, including 15 bispecific antibodies. With seven commercially available drugs and advanced R&D platforms, Akeso is committed to developing first- and best-in-class therapies for patients worldwide.

Prepared by the Selesta Research Team.

research@selesta.ai

Selesta is a healthcare and life science advisory firm dedicated to serving Asia’s emerging entrepreneurs and businesses.

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