This week’s China healthcare highlights include Zhejiang Jingxin Pharmaceutical’s submission of a Hong Kong IPO prospectus to fund its CNS and cardiovascular drug pipelines, Huadong Medicine’s initiation of a head-to-head Phase III trial for GLP-1/GIP dual agonist poterepatide against Innovent’s mazdutide, and Hansoh Pharmaceutical’s EU approval for third-generation EGFR-TKI aumolertinib (Ameile/Aumseqa) for advanced NSCLC. CSPC received FDA clearance for clinical trials of SYH2082, a long-acting GLP-1/GIP dual-biased agonist injection for weight management. These updates underscore China’s continued innovation and global expansion in CNS, oncology, and metabolic disorder therapies.

Clinical

Zhejiang Jingxin Pharmaceutical (002020.SZ) Submits IPO Prospectus for Hong Kong Listing

Key Words: Zhejiang Jingxin Pharmaceutical, Hong Kong IPO, CNS diseases, cardiovascular diseases, innovative drugs, generics, R&D pipeline

The News: Zhejiang Jingxin Pharmaceutical, an A-share listed company based in Zhejiang, China, has submitted its prospectus to the Hong Kong Stock Exchange for a proposed IPO on the Main Board. Jingxin, which went public on the A-share market in July 2004, had a market capitalization of approximately RMB 14.6 billion as of February 11, 2026.

Key Highlights:

• Jingxin specializes in central nervous system (CNS) and cardiovascular diseases, leveraging a diversified portfolio of generics, traditional Chinese medicines, biologics, APIs, and medical devices. The company has over 60 approved drugs and focuses on combining commercialization of marketed products with the advancement of its R&D pipeline.
• Innovative Drug Pipeline:
  • Key assets include Didasini®, an innovative drug for insomnia already commercialized in China, JX2201 for hyperlipoproteinemia (under development), and Karilazine capsules, currently under regulatory review in China.
  • The company’s pipeline focuses on CNS conditions such as schizophrenia, epilepsy, depression, and Parkinson’s disease, as well as cardiovascular and cerebrovascular diseases.
• Revenue reached RMB 39.99 billion in 2023, RMB 41.59 billion in 2024, and RMB 33.44 billion for the first 10 months of 2025, with gross margins of 49.2% in 2023 and 48.5% in 2024. Net profit amounted to RMB 6.24 billion in 2023 and RMB 7.19 billion in 2024.
• IPO Proceeds Utilization: Funds will be allocated to R&D activities, expansion of the marketing network, potential acquisitions or licensing deals, and general corporate purposes to support future growth.

Clinical

Huadong (000963.SZ) Tests GLP-1/GIP Dual Agonist Head-to-Head Against Mazdutide

Key Words: Huadong Medicine, poterepatide, GLP-1/GIP dual agonist, Innovent Biologics, mazdutide, GLP-1/GCGR dual agonist, type 2 diabetes, Phase III clinical trial

The News: Huadong Medicine has initiated its first head-to-head Phase III clinical trial for its GLP-1/GIP dual agonist, poterepatide. The multi-centre, randomised, open-label study will enrol 912 patients to compare the efficacy and safety of weekly subcutaneous injections of poterepatide against mazdutide, a GLP-1/GCGR dual agonist developed by Innovent Biologics. The primary endpoint is the change in haemoglobin A1c (HbA1c) from baseline in patients with type 2 diabetes (T2D) inadequately controlled by metformin alone or in combination with an SGLT2 inhibitor.

Key Highlights:

• In a Phase II study, poterepatide demonstrated significant weight loss efficacy, with participants losing over 13% of their body weight after 22 weeks of treatment.
• Study Design:
  • The Phase III trial will evaluate the efficacy and safety of poterepatide versus mazdutide in 912 patients with T2D.
  • The primary endpoint is the change in haemoglobin A1c (HbA1c) from baseline, targeting patients inadequately controlled by metformin alone or in combination with an SGLT2 inhibitor.
• Mechanisms of Action:
  • Poterepatide is designed to activate both GLP-1 and GIP receptors, improving glycaemic control and promoting weight loss.
  • Mazdutide, approved in China in September 2025, is a GLP-1/GCGR dual agonist targeting GLP-1 and glucagon receptors for T2D and weight management.

Hansoh (3692.HK) TKI Aumolertinib Gains Marketing Authorisation in EU

Key Words: Hansoh Pharmaceutical, aumolertinib, Ameile, Aumseqa, EGFR-TKI, NSCLC, EU approval, T790M mutation, EGFR exon 19 deletion, exon 21 L858R substitution, Glenmark Pharmaceuticals

The News: Hansoh Pharmaceutical has received marketing authorisation in the European Union (EU) for its third-generation EGFR tyrosine kinase inhibitor (TKI), Ameile/Aumseqa (aumolertinib). The approval covers two adult indications: the first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and the treatment of advanced EGFR T790M mutation-positive NSCLC. Aumolertinib is the first China-developed third-generation EGFR-TKI to gain approval in the EU.

Key Highlights:

• Approved for the first-line treatment of advanced NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as well as for advanced EGFR T790M mutation-positive NSCLC.
• Regulatory Milestones:
  • Aumolertinib is already approved in China for five indications, including adjuvant therapy and first- and second-line treatments for advanced NSCLC.
  • The EU approval comes after the drug’s marketing authorisation in the United Kingdom in June 2025.
• Global Expansion: In December 2025, Hansoh granted Glenmark Pharmaceuticals exclusive multi-region commercial rights to aumolertinib, signalling a strategic move to expand its global footprint.

CSPC’s (1093.HK) SYH2082 Receives FDA Approval for Clinical Trials as a Long-Acting GLP-1/GIP Dual Agonist

Key Words: CSPC, SYH2082, GLP-1/GIP dual agonist, long-acting injection, FDA approval, weight management, T2DM, metabolic disorders

The News: CSPC Pharmaceutical Group has received FDA approval for the clinical trials of SYH2082, a long-acting GLP-1/GIP dual-biased agonist injection. Developed using CSPC’s proprietary long-acting formulation technology platform, SYH2082 is designed for once-monthly administration, aiming to enhance patient compliance and convenience. The approved indication targets weight management for obesity or overweight patients with at least one weight-related comorbidity.

Key Highlights:

• SYH2082 selectively activates the cAMP pathway while reducing β-arrestin recruitment, minimizing receptor endocytosis and desensitization, thereby enhancing efficacy and prolonging action duration.
• Its long half-life modification and advanced formulation technologies support continuous weight loss benefits within the monthly dosing interval.
• Promising Preclinical Results:
  • Preclinical studies demonstrated superior efficacy in sustained weight loss and maintenance compared to marketed products, validating the once-monthly dosing regimen.
  • Toxicology studies showed good tolerability with no significant adverse effects observed.
• Beyond weight management, SYH2082 has potential to improve glycemic control in adults with type 2 diabetes (T2DM), offering additional clinical benefits.

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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