This week’s China healthcare and pharma roundup highlights Legend Biotech’s secondary listing plans, Rapafusyn’s USD 44M Series A, Betta Pharmaceuticals’ Hong Kong IPO, iRegene’s Series B+ for Parkinson’s iPSC therapy, and key updates including Junshi’s IL-17A psoriasis biologic, Henlius’ US denosumab biosimilars approval, Yangtze River’s reflux oesophagitis P-CAB launch, BioMarin’s achondroplasia drug filing, and Biokin’s NSCLC ADC showing 100% ORR.

Transactions & BD (In/Out Licensing)

Legend Biotech (NASDQAQ: LEGN) Plans Secondary Listing Amid Profitability Challenges

Key Words: Legend Biotech, CAR-T, secondary listing, profitability

• The News: Legend Biotech is exploring a secondary listing in Hong Kong, Singapore, or London, aiming to address profitability challenges in the competitive cell therapy market. Discussions with advisors have begun, but details remain undisclosed.
• Key Highlights:
• Founded in 2014 as a Genscript incubator project, Legend Biotech gained recognition with its BCMA CAR-T product Carvykti (ciltacabtagene autoleucel), approved by the FDA in 2022.
• Despite Carvykti’s strong performance, including USD 808 million in H1 2025 sales (+136% YoY in Q2), Legend remains unprofitable.
• The company reported a USD 177 million net loss in 2024 and USD 226.3 million in H1 2025, despite a 60.46% YoY revenue increase.

Rapafusyn Secures USD 44m Series A for Molecular Glue Platform

Key Words: molecular glue, oncology, FKBP12

• The News: Rapafusyn Pharmaceuticals raised USD 44 million in Series A funding, led by BioTrack Capital and Yonjin Capital, to advance its RapaGlue platform for non-degrading molecular glues targeting undruggable proteins.
• Key Highlights:
• Lead programs include an ENT1 inhibitor for renal disease, showing reduced inflammation in pre-clinical models.
• The platform uses DNA-encoded libraries and machine learning to design macrocyclic compounds with superior drug-like properties.
• Funding will support development in oncology, immunology, nephrology, and pain therapeutic areas.

Betta Pharmaceuticals (SZSE: 300558) Plans Hong Kong Listing

Key Words: Betta Pharmaceuticals, Hong Kong IPO, ensartinib

• The News: On September 11, Betta Pharmaceuticals announced plans to issue H-shares and seek a listing on the Hong Kong Stock Exchange to strengthen its capital base and accelerate internationalization.
• Key Highlights:
• The H-share issuance will be no more than 15% of the company’s total share capital post-issuance, targeting global investors.
• Proceeds will support R&D, pipeline expansion, global commercialization, potential acquisitions, and marketing network development.
• Betta reported H1 2025 revenue of RMB 1.731 billion (+15.37% YoY), with flagship products icotinib (Conmana®) and ensartinib (Bemena®) contributing over 10% of total revenue.
• This marks Betta’s renewed attempt after two prior Hong Kong listing applications in 2021, reflecting stronger confidence in its strategy.

iRegene Therapeutics Secures Series B+ Financing Following FDA Fast Track Designation for NouvNeu001

Key Words: iRegene Therapeutics, Series B+ financing, NouvNeu001, Parkinson’s disease

• The News: iRegene Therapeutics announced the successful completion of its Series B+ financing round, raising over RMB 300 million (~USD 40M), co-led by Northern Light Venture Capital, Chuangjing Capital, and OneHealth Haihe Capital.
• Key Highlights:
• NouvNeu001, iRegene’s flagship product and the world’s first allogeneic iPSC-derived cell therapy for Parkinson’s disease, received FDA Fast Track Designation (FTD) in August 2025.
• The financing marks the largest single funding in China’s iPSC sector in recent years, underscoring investor confidence in iRegene’s leadership.
• Proceeds will accelerate the global clinical development of NouvNeu001 for Parkinson’s disease and NouvSight001 for retinal degenerative diseases, while strengthening R&D, manufacturing, and operational capabilities.

Clinical Development

Junshi’s (HKEX: 01877) IL-17A Inhibitor Succeeds in Late-Stage Psoriasis Trial

Key Words: IL-17A, psoriasis, biologics

• The News: Junshi Biosciences reported positive Phase III results for its IL-17A monoclonal antibody JS005 in moderate-to-severe plaque psoriasis, meeting all co-primary endpoints including PASI 90 and sPGA 0/1 at week 12.
• Key Highlights:
• The trial enrolled 747 patients, demonstrating significant skin clearance and a favourable safety profile.
• Junshi plans regulatory submissions to China’s NMPA imminently.
• JS005 joins competitive IL-17 inhibitors like Novartis’ secukinumab and Lilly’s ixekizumab in a biologics-dominated market.

Henlius’s (HKEX: 02696) Denosumab Biosimilar Enter US Market

Key Words: denosumab, biosimilars, osteoporosis, bone metastasis

• The News: China-based Henlius Biotech has received US regulatory approval for its denosumab biosimilar Bildyos (60mg/mL) and Bilprevda (120mg/1.7mL). These products cover all eight indications of Amgen and GSK’s reference products, Prolia and Xgeva, for osteoporosis and bone metastasis complications.
• Key Highlights:
• This marks China’s first denosumab biosimilar approval overseas and Henlius’ third US-approved product.
• The approval follows its 2022 USD 541 million licensing deal with Organon for ex-China commercialisation rights.
• Henlius demonstrated full development and manufacturing capabilities with 48,000-litre capacity and a 100% regulatory inspection pass rate.
• Marketing applications are underway in the EU and Canada, with EMA approval anticipated by July 2025.

Yangtze River, Daewoong’s PPI Approved for Reflux Oesophagitis in China

Key Words: reflux oesophagitis, fexuprazan, proton pump inhibitor

• The News: Yangtze River Pharma has secured Chinese approval for fexuprazan, a potassium-competitive acid blocker (P-CAB) co-developed with South Korea’s Daewoong Pharmaceutical, for reflux oesophagitis.
• Key Highlights:
• Phase III trials demonstrated superior acid suppression and faster onset compared to traditional PPIs like esomeprazole.
• Yangtze subsidiary Haini Pharma licensed Chinese rights for up to USD 338 million in 2021.
• Fexuprazan introduces a new class of acid suppressants to challenge established PPIs in China’s gastrointestinal market.

BioMarin’s (NASDQAQ: BMRN) Vosoritide Becomes First Drug Filed for Achondroplasia in China

Key Words: vosoritide, achondroplasia, dwarfism

• The News: BioMarin Pharmaceutical has submitted vosoritide for Chinese approval, the first therapy for paediatric achondroplasia. This follows its 2021 accelerated US approval for children aged five years and older with open growth plates.
• Key Highlights:
• Vosoritide counteracts FGFR3 mutations, improving linear growth by 1.57 cm/year over placebo in Phase III trials.
• The therapy addresses unmet needs in dwarfism, affecting 50,000 patients in China, and expands access to regions where no pharmacological treatments existed.
• Approved in the US, EU, Japan, and South Korea, vosoritide is also being developed for Turner syndrome.

Biokin’s (688506.SH) Iza-Bren Plus Osimertinib Shows 100% ORR in EGFR-Mutated NSCLC in Phase II

Key Words: EGFR-mutated NSCLC, ADC, osimertinib

• The News: Iza-bren, a bispecific antibody-drug conjugate (ADC) developed by Sichuan Biokin Pharmaceutical Co., Ltd (Biokin), achieved a 100% objective response rate (ORR) in combination with osimertinib for EGFR-mutated NSCLC in a Phase II study presented at IASLC.
• Key Highlights:
• Median follow-up of 12.8 months showed a 95% confirmed ORR, with a 12-month progression-free survival rate of 92.1%.
• Most adverse events (AEs) were hematological, including anemia and neutropenia, but were manageable with supportive care and dose modifications.
• The combination offers a potentially transformative first-line treatment option for advanced NSCLC.

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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