This week’s China healthcare highlights include Rapport Therapeutics licensing its Phase III-ready epilepsy drug RAP-219 to YuanYi Bio in a US$328M Greater China deal, and Eli Lilly’s US$3B investment in China to localize orforglipron production. In clinical advancements, 3SBio’s bispecific antibody SSS67 targeting ActRIIA/ActRIIB received US trial approval, Harbour BioMed’s long-acting bispecific antibody HBM7575 entered China trials for atopic dermatitis, and Essight Bio’s RAS G12V-targeting bispecific ES502 was FDA-cleared for solid tumors. DualityBio’s CDH17 ADC AMT-676 entered Phase II for colorectal cancer, Hansoh’s GLP-1/GIP dual agonist olatorepatide achieved 19.3% weight loss in Phase III, and Laekna’s ActRIIA inhibitor LAE102 showed muscle gain and fat reduction in Phase I. These milestones highlight China’s innovation in licensing and metabolic disorder therapies.

Transactions

Rapport Therapeutics (RAPP.O) Licenses TARPγ8-Targeting Epilepsy Drug RAP-219 to YuanYi Bio in US$ 328M Greater China Deal

Key Words: Rapport Therapeutics, YuanYi Bio, RAP-219, TARPγ8, AMPA receptor, epilepsy, licensing agreement, focal onset seizures

The News: Rapport Therapeutics has granted Shanghai YuanYi Bio exclusive rights to develop and commercialize RAP-219 in Greater China. The deal is worth up to US$328 million, including US$20 million upfront, up to US$ 308 million in milestones, and tiered royalties in the low- to mid-teens. RAP-219 is preparing to enter Phase III trials for drug-resistant focal onset seizures, with global registrational studies expected to begin in Q2 2026.

Key Highlights:

• Deal Details:
  • Total deal value: Up to US$ 328 million.
  • Upfront payment: US$ 20 million.
  • Additional payments: Up to US$ 308 million in development and commercial milestones.
• RAP-219: TARPγ8-selective AMPA receptor negative allosteric modulator designed to reduce pathological excitatory signalling.
• Clinical Progress:
  • Phase IIa: 85.2% of patients achieved ≥30% seizure reduction; 24% became seizure-free after eight weeks.
  • Demonstrated good tolerability with once-daily oral dosing.

Lilly (NYSE: LLY) Announces US$ 3 Billion Investment in China to Bolster Local Supply Chain

Key Words: Eli Lilly, Pharmaron, orforglipron, GLP-1 receptor agonist, supply chain

The News: Eli Lilly has announced plans to invest a cumulative US$ 3 billion over the next decade to expand its manufacturing and supply chain capacity in China. The investment will support the localization of production for its oral small-molecule GLP-1 receptor agonist orforglipron, whose new drug application (NDA) was accepted by China’s National Medical Products Administration (NMPA) in January 2026. As part of the initiative, Lilly has entered a strategic collaboration with Chinese CDMO Pharmaron (3759.HK), committing an initial US$ 200 million investment to strengthen the company’s manufacturing capabilities.

Key Highlights:

• Investment Details:
  • Total investment: Up to US$ 3 billion.
  • Initial commitment: US$ 200 million investment in Pharmaron.
• GLP-1 Pipeline Expansion:
  • The initiative aims to localise production of innovative medicines and improve supply chain resilience in China.
  • Reflects increasing collaboration between multinational pharma companies and Chinese manufacturing partners.
• The investment will support localized production of orforglipron, Lilly’s oral GLP-1 receptor agonist, whose NDA was accepted by the NMPA in January 2026 for cardiometabolic diseases.

Clinical

3SBio’s (1530.HK) Bispecific Antibody SSS67 Receives US Clinical Trial Approval

Key Words: 3SBio, SSS67, ActRIIA, ActRIIB, bispecific antibody, obesity, metabolic disorders, muscle mass, clinical trial

The News: 3SBio has received approval in the United States to initiate clinical trials for SSS67, a tetravalent bispecific antibody targeting ActRIIA and ActRIIB receptors. SSS67 is designed to simultaneously regulate pathways involved in fat metabolism and muscle synthesis. By modulating activin receptor signaling, the therapy aims to deliver dual therapeutic benefits—reducing adipose tissue while increasing muscle mass—addressing the growing global burden of obesity and metabolic disorders.

Key Highlights:

• Preclinical studies of SSS67 demonstrated simultaneous reductions in fat mass and increases in lean muscle mass through modulation of the activin receptor signalling pathway.
• SSS67 is designed to improve overall body composition rather than GLP-1–based therapies, leading the loss of lean muscle during weight reduction.

Harbour BioMed’s (2142.HK) Long-Acting TSLP Bispecific Antibody HBM7575 Receives Clinical Trial Approval in China

Key Words: Harbour BioMed, HBM7575, TSLP, bispecific antibody, atopic dermatitis, long-acting antibody, H2L2 platform, clinical trial

The News: Harbour BioMed has received clinical trial approval in China for HBM7575, a long-acting bispecific antibody targeting TSLP and an undisclosed immune pathway for the treatment of atopic dermatitis. The candidate, co-developed with Kelun-Biotech, is engineered to inhibit TSLP-driven Th2 inflammation while blocking an additional immune target, with the aim of improving efficacy beyond TSLP monoclonal antibodies. The antibody is designed with extended half-life properties that could enable dosing intervals exceeding three months.

Key Highlights:

• Clinical Development:
  • HBM7575 has entered clinical development following regulatory clearance in China.
  • The first-in-human study will assess safety, pharmacokinetics, and preliminary efficacy in patients with atopic dermatitis.
• HBM7575 simultaneously targets TSLP and a second undisclosed immune pathway to enhance anti-inflammatory activity beyond TSLP monoclonal antibodies.
• The approach reflects growing interest in multi-target biologics for Th2-driven diseases such as atopic dermatitis.

Essight Bio’s First-in-Class RAS G12V-Targeting TCRxCD3 Bispecific ES502 Cleared by FDA for Phase I Trial

Key Words: Essight Bio, ES502, TCRxCD3, T-cell engager, RAS G12V, pHLA complex, solid tumors, Phase I trial

The News: Shanghai-based Essight Biotechnology has received FDA clearance to initiate a Phase I clinical trial of ES502, a next-generation TCRxCD3 bispecific T-cell engager targeting RAS G12V mutations across advanced solid tumors. The therapy is designed to recognize the peptide–HLA (pHLA) complex formed by the RAS G12V neoantigen, enabling T-cell-mediated killing of tumor cells harboring this intracellular mutation.

Key Highlights:

• ES502 Profile:
  • ES502 is the first TCRxCD3 bispecific antibody globally to enter clinical development for the RAS G12V mutation.
  • Enable selective targeting of intracellular oncogenic mutations.
  • Received FDA clearance to initiate a Phase I clinical trial.
• Clinical Efficacy:
  • Over 100× higher affinity than CD3, enabling precise tumor recognition.
  • The approach leverages TCR-mimic targeting to access intracellular oncogenic drivers, traditionally considered “undruggable.”
• Potential to Address RAS Resistance:
  • RAS G12V mutations account for ~4-5% of all solid tumors, representing a large unmet clinical need.
  • TCR-based immune redirection may help overcome resistance mechanisms emerging from RAS inhibitor therapies.

DualityBio’s (9606.HK) CDH17-Targeting ADC AMT-676 Enters Global First Phase II Trial

Key Words: DualityBio, AMT-676, CDH17, ADC, colorectal cancer, exatecan, Phase II trial, antibody-drug conjugate

The News: DualityBio has initiated a Phase II clinical trial in China evaluating its CDH17-targeting antibody-drug conjugate (ADC), AMT-676, in combination with standard chemotherapy regimens for patients with advanced colorectal cancer. The study (CTR20260849) will assess the safety and efficacy of AMT-676 combined with 5-fluorouracil, leucovorin, and bevacizumab or cetuximab. The trial plans to enroll 180 patients and will be led by Prof. Ruihua Xu at Sun Yat-sen University Cancer Center.

Key Highlights:

• AMT-676 Profile:
  • AMT-676 is the first CDH17-targeting ADC into Phase II clinical development.
  • CDH17 is highly expressed in gastrointestinal malignancies, particularly colorectal cancer, making it a promising therapeutic target.
• Clinical Development:
  • Evaluate the safety and efficacy of AMT-676 combined in phase II study.
  • Approximately 180 patients will be enrolled across multiple sites in China.
• AMT-676 consists of a humanized CDH17-targeting IgG1 antibody linked to the topoisomerase I inhibitor exatecan via a protease-cleavable linker, with a drug-to-antibody ratio (DAR) of 4.

CirCode Bio’s Circular RNA Therapy HM2003 Receives FDA IND Clearance and Rare Pediatric Disease Designation

Key Words: CirCode Bio’s Circular RNA Therapy HM2003 Receives FDA IND Clearance and Rare Pediatric Disease Designationt

The News: Shanghai-based CirCode Bio announced that its circular RNA therapeutic HM2003 has received IND clearance from the US Food and Drug Administration (FDA), enabling the initiation of global clinical trials. The candidate has also been granted Rare Pediatric Disease Designation (RPDD) for an undisclosed indication and previously received Orphan Drug Designation (ODD) for thromboangiitis obliterans (TAO).

Key Highlights:

• Clinical Development:
  • FDA IND clearance enables HM2003 to enter global clinical trials.
  • The therapy is designed to stimulate collateral blood vessel formation and improve perfusion in ischemic tissues.
• HM2003 Profile:
  • Received both Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD).
  • RPDD eligibility could allow the company to obtain a transferable Priority Review Voucher (PRV) upon regulatory approval.
• HM2003 is developed using CirCode Bio’s covalently closed circular RNA platform, designed to improve RNA stability and reduce immunogenicity compared with linear RNA therapeutics.

Hansoh’s (3692.HK) GLP-1/GIP Dual Agonist Shows 19.3% Weight Loss in Phase III

Key Words:Hansoh Pharmaceutical, olatorepatide, GLP-1/GIP dual agonist, obesity, weight management, Phase III trial

The News: Hansoh Pharmaceutical has announced positive topline results from a Phase III trial of its GLP-1/GIP dual receptor agonist, olatorepatide, for weight management. The study enrolled 604 Chinese adults with overweight or obesity and met its co-primary endpoints. After 48 weeks of treatment, the highest dose achieved an average weight reduction of 19.3% from baseline, with 97.2% of participants achieving at least 5% weight loss. Olatorepatide is a once-weekly subcutaneous injection designed to regulate appetite, glucose metabolism, and energy balance.

Key Highlights:

• Clinical Data:
  • Average weight reduction of 19.3% at 48 weeks.
  • 2% of participants achieved ≥5% weight loss.
• Dual-Indication Development Strategy:
  • Olatorepatide is currently in Phase III trials for both obesity and type 2 diabetes (T2D).
  • The once-weekly injectable therapy targets GLP-1 and GIP pathways to regulate appetite, glucose metabolism, and energy balance.
• The therapy demonstrated favorable gastrointestinal tolerability, with lower rates of GI adverse events and treatment discontinuation compared with published data for other GLP-1-based dual agonists.

Laekna’s (2105.HK) ActRIIA Inhibitor Shows Promising Muscle Gain, Fat Loss

Key Words: Laekna Therapeutics, LAE102, ActRIIA inhibitor, monoclonal antibody, muscle mass, obesity, Phase I trial

The News: Laekna Therapeutics has reported positive results from a US Phase I single ascending dose study of LAE102, a selective ActRIIA-targeting monoclonal antibody designed to regulate muscle growth and fat metabolism. In the highest exposure cohort, participants achieved a mean increase of 5.06% in lean body mass and a mean reduction of 0.12% in fat mass following a single dose, while placebo participants experienced a decrease in lean mass and an increase in fat mass. The therapy was well tolerated with no serious adverse events reported.

Key Highlights:

• Preclinical and Clinical Data:
  • Preclinical: LAE102 may mitigate muscle loss associated with GLP-1–based weight loss therapies
  • Achieved a 5.06% increase in lean body mass following a single dose of LAE102 in Phase I.
  • Fat mass decreased by 0.12% in Phase I.
• LAE102 selectively inhibits ActRIIA, a key regulator of muscle regeneration and metabolic balance where the mechanism may enable simultaneous muscle gain and fat reduction.
• Laekna Therapeutics plans to advance Phase II trials combining LAE102 with incretin-based treatments.

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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