This week’s China healthcare roundup highlights Kite Pharma’s US$1.64B in vivo CAR-T deal with Pregene, Xuanzhu Biopharma’s HKEX debut with a 172% grey market premium, Hansoh’s US$1.53B CDH17 ADC licensing to Roche, and Leads Biolabs’ US$1B autoimmune drug deal with Dianthus. Biokin secured a record US$250M milestone from BMS, while I-Mab rebrands as NovaBridge and plans an HKEX listing. Key clinical updates include Kelun’s ADC advances, Hemay’s PDE4 inhibitor approval, CSPC’s GLP-1 NDA, Qilu’s PROTAC progress, and RemeGen’s IgA nephropathy NDA.

Transactions & BD (In/Out Licensing)

Kite Pharma Partners with Pregene Biopharma for Next-Gen In Vivo CAR-T Therapies in US$ 1.64 Billion Deal

Key Words: Kite Pharma, Pregene Biopharma, in vivo CAR-T, oncology, partnership

The News: Gilead Sciences’ (GILD.O) Kite Pharma has partnered with China-based Pregene Biopharma to research and develop next-generation in vivo CAR-T therapies. The deal is valued at up to US$ 1.64 billion, including an upfront payment of US$ 120 million to Pregene and up to US$ 1.52 billion in milestone payments.

Key Highlights:

• The collaboration focuses on advancing in vivo CAR-T therapies for oncology, autoimmune diseases, and other areas requiring innovation. By integrating complementary technologies and expertise, the partnership aims to deliver clinical proof-of-concept studies for in vivo
• This agreement builds on Kite’s prior US$ 350 million acquisition of Interius BioTherapeutics to enhance its in vivo CAR-T platform capabilities, signaling an aggressive push into next-generation cell therapy technologies.

Xuanzhu Biopharma (2575.HK) Debuts on HKEX With 172% Grey Market Premium

Key Words: IPO, HKEX, oncology, Xuanzhu

The News: Xuanzhu Biopharm, a spin-off from Sihuan Pharmaceutical (0460.HK), has listed on the Hong Kong Stock Exchange (HKEX) at HKD 11.60 per share, achieving a market capitalization of HKD 6.01 billion. The IPO saw a record 3,960 times retail oversubscription and a 172% grey market premium.

Key Highlights:

• The company holds three drug approvals, including proton pump inhibitor KBP-3571 for digestive diseases, CDK4/6 inhibitor XZP-3287 for breast cancer, and ALK inhibitor XZP-3621 for non-small cell lung cancer (NSCLC). Its pipeline includes ten clinical-stage assets targeting oncology, metabolic diseases, and gastroenterology, with seven total new drug applications submitted or approved.
• Xuanzhu generated RMB 32.7 million in sales for its first commercialized product, KBP-3571, through March 2025. However, its net losses rose 26.5% to RMB 65.5 million in Q1 2025 due to elevated R&D investment, which accounted for 77.6% of operating expenses.

Hansoh (3692.HK) Licenses CDH17 ADC to Roche in US$ 1.53Billion Deal

Key Words: Hansoh, Roche, CDH17 ADC, colorectal cancer, licensing

The News: Hansoh Pharma has granted Roche (ROG.SW) global exclusive rights (excluding Greater China) for its CDH17-targeting antibody-drug conjugate (ADC) HS-20110 under a US$ 1.53 billion agreement. The deal includes an US$ 80 million upfront payment and up to US$ 1.45 billion in development and commercialization milestones. Hansoh retains rights in mainland China, Hong Kong, Macau, and Taiwan, with potential for tiered royalty payments on ex-China sales.

Key Highlights:

• HS-20110 is in global Phase I trials in colorectal cancer (CRC) and other solid tumours in China and the US, focusing on safety and preliminary efficacy.
• The candidate takes a novel approach by targeting CDH17 overexpression in gastrointestinal cancers, including gastric and colorectal malignancies, where advanced-stage treatment options remain limited.
• This partnership bolsters Roche’s oncology pipeline, complementing its ADC platforms, while Hansoh expands its global presence, building on previous out-licensing deals for its EGFR exon 20 inhibitor and B7-H3 ADC candidates.

Leads Biolabs (9887.HK) Licenses BDCA2/TACI Fusion Protein to Dianthus in US$ 1Billion Deal

Key Words: BDCA2, TACI, autoimmune diseases, Leads Biolabs, Dianthus

The News: Leads Biolabs has signed an exclusive global licensing agreement with Dianthus Therapeutics for its preclinical bispecific fusion protein LBL-047, targeting BDCA2 and TACI pathways in autoimmune diseases. The agreement is valued at up to US$ 1 billion, including US$ 38 million in upfront and near-term milestone payments. Leads retains rights in Greater China and will earn tiered royalties on ex-China net sales ranging from mid-single to low-double digits.

Key Highlights:

• LBL-047 is a first-in-class candidate designed to selectively deplete plasmacytoid dendritic cells to reduce type one interferon (IFN-I) production while simultaneously inhibiting BlyS and APRIL signalling. This dual mechanism addresses key drivers of autoimmune pathogenesis, including aberrant interferon activation and B-cell dysregulation, with potential applications in systemic lupus erythematosus (SLE), Sjogren’s syndrome, and other rheumatic conditions.
• The long-acting fusion protein design allows for sustained pathway inhibition with reduced dosing frequency compared to conventional monoclonal antibodies (mAbs).
• This deal enhances Dianthus Therapeutics’ portfolio, which focuses on complement pathway inhibitors, and supports Leads Biolabs’ globalisation strategy, following prior out-licensing deals for immuno-oncology assets.

Biokin Earns Record US$ 250 Million Milestone Payment for Bispecific ADC From BMS (BMY.N)

Key Words: bispecific ADC, milestone payment, BMS, izalontamab brengitecan

The News: Biokin will receive a US$ 250 million milestone payment from Bristol Myers Squibb (BMS) after achieving a clinical milestone in the global Phase II/III IZABRIGHT-Breast01 trial for EGFR/HER3 bispecific antibody-drug conjugate (ADC) izalontamab brengitecan. This marks the largest single milestone payment in Chinese innovative drug out-licensing history. The transaction stems from an US$ 800 million upfront payment in a December 2023 agreement, with a potential total value of US$4 billion, including development and commercialisation milestones.

Key Highlights:

• Izalontamab brengitecan is the first-in-class bispecific ADC to advance to Phase III development and has received breakthrough therapy designation (BTD) in the US for urothelial carcinoma.
• Biokin’s pipeline features 15 clinical-stage assets, including HER2-targeting ADC BL-M07D1, which is undergoing three Phase III trials in breast cancer, and CD33-directed ADC BL-M11D1 for acute myeloid leukemia (AML). The company is conducting 40 izalontamab brengitecan trials globally, including 11 Phase III studies in China, with seven BTDs and priority review for recurrent metastatic nasopharyngeal carcinoma.
• This milestone achievement highlights Biokin’s ability to create sustainable value beyond initial licensing deals, further validating China’s innovative drug development capabilities in targeted oncology therapeutics.

I-Mab (IMAB.O) to Rebrand as NovaBridge and Pursue Hong Kong Dual Listing

Key Words: I-Mab, NovaBridge, dual listing, HKEX

• The News: US-China biotech I-Mab has announced plans to rebrand as NovaBridge Biosciences and pursue a dual listing on the HKEX while retaining its Nasdaq position. Shareholders will vote on the rebrand during an extraordinary meeting on October 24.
• Key Highlights:
• The transition reflects I-Mab’s evolution into a global biotech platform, focusing on business development and translational clinical innovation. Executive Chairman Fu Wei emphasized the move as a strategy to accelerate access to innovation by forming global partnerships and unlocking new capital opportunities in Asia.
• I-Mab is launching Visara, a new subsidiary dedicated to ophthalmic therapies, which will acquire VIS-101—a bifunctional biologic targeting VEGF-A and Ang-2. Currently in Phase II trials, VIS-101 is expected to be Phase III-ready by 2026. The subsidiary will be funded with $37 million from I-Mab.
• The company’s strategic shift includes a focus on global business development and advancing innovative medicines. With a gross profit margin of 81.77% and a current ratio of 1.36, I-Mab appears financially equipped for this transformation.

Clinical Development

Kelun’s (002422.SZ) CLDN18.2 ADC Shows Promising Data in Gastric Cancer

Key Words: ADC, gastric cancer, ESMO 2025, CLDN18.2

The News: Kelun-Biotech presented Phase I data for its CLDN18.2-targeting antibody-drug conjugate (ADC) SKB315 at the 2025 ESMO congress. The drug achieved a 37.5% objective response rate (ORR) and a median progression-free survival (mPFS) of 8.2 months in heavily pretreated gastric/gastroesophageal junction cancer patients.

Key Highlights:

• SKB315 uses a novel topoisomerase I inhibitor payload with a pH-sensitive cleavable linker, enabling a bystander effect, stable circulation, and tumour-specific release to minimize gastric toxicity. The ADC showed a manageable safety profile with 39.7% grade three or higher treatment-related adverse events (TRAEs), mainly haematological, and no treatment-related deaths.
• The competitive landscape includes Innovent Biologics’ IBI343 (47.1% ORR) and Hengrui Medicine’s SHR-A1904 (25.0% ORR in high expressors). SKB315 offers differentiated design features, such as an optimized drug-to-antibody ratio (DAR) and superior pre-clinical affinity compared to zolbetuximab.
• Kelun-Biotech is planning combination studies with immunotherapy for first-line gastric cancer and expanding into pancreatic cancer and other CLDN18.2-positive malignancies.

Kelun (002422.SZ) Gains Third Approval for TROP2 ADC in EGFR-Mutant NSCLC

Key Words: TROP2, ADC, NSCLC, EGFR, NMPA

The News: Kelun-Biotech has received its third approval from China’s National Medical Products Administration (NMPA) for the TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan. The approval is for treating EGFR-mutant non-small cell lung cancer (NSCLC) patients who progressed after tyrosine kinase inhibitor (TKI) therapy. The Phase III OptiTROP-Lung04 trial demonstrated significant progression-free survival (PFS) improvement compared to pemetrexed-platinum chemotherapy, with a favourable safety profile.

Key Highlights:

• Sacituzumab tirumotecan features a novel linker technology with a 7.4 drug-to-antibody ratio (DAR), delivering a belotecan-derived topoisomerase I inhibitor payload with bystander effect potential.
• This approval follows prior indications for triple-negative breast cancer (TNBC) in November 2024 and non-squamous NSCLC post-chemotherapy progression in March 2025. The ADC has demonstrated broad utility across solid tumours, including gastric cancer and gynaecological malignancies, by targeting TROP2 overexpression in epithelial cancers.
• Kelun’s partnership with MSD strengthens its global development capabilities, aiming to address significant unmet needs in TKI-resistant lung cancer populations through a novel mechanism that overcomes resistance pathways.

Hemay Secures NMPA Approval for China’s First Domestic PDE4 Inhibitor

Key Words: PDE4 inhibitor, plaque psoriasis, NMPA, mufemilast

The News: Hemay Biological has received approval from China’s National Medical Products Administration (NMPA) for mufemilast, marking it as the first domestically developed PDE4 inhibitor for plaque psoriasis. The approval is based on Phase III trial results showing a 53.6% PASI-75 response rate compared to 16.0% for placebo with 60mg twice-daily dosing.

Key Highlights:

• Mufemilast is a small molecule that modulates cAMP and cGMP levels to control inflammatory cytokine production, with potential applications across various inflammatory conditions. Hemay is also conducting an additional Phase III trial in Behcet’s disease, following positive Phase II results that demonstrated reduced oral ulcer counts and accelerated healing compared to placebo.
• Safety data from the Behcet’s disease trial showed 6.7% to 6.9% treatment discontinuation rates due to adverse events, most of which were mild.
• This approval is a significant milestone for China’s innovative drug development in dermatology and autoimmune diseases, addressing treatment gaps in chronic inflammatory conditions through a novel mechanism of action.

CSPC (1093.HK) Files NDA for GLP-1 Analogue Targeting Obesity in China

Key Words: GLP-1 analogue, obesity, weight management, CSPC, NDA

The News: CSPC Pharma has submitted a new drug application (NDA) to China’s National Medical Products Administration (NMPA) for efmedaglutide alfa, a GLP-1 analogue designed as a weekly subcutaneous injection for long-term weight management in overweight or obese adults. The recombinant human GLP-1 Fc fusion protein achieved significant weight reduction and improvements in waist circumference, blood glucose, blood pressure, and lipid profiles in Phase III trials versus placebo.

Key Highlights:

• Efmedaglutide alfa demonstrated favourable gastrointestinal tolerability, lower treatment discontinuation rates due to adverse events, and a simplified four-week dose escalation protocol compared to existing GLP-1 receptor agonists.
• As a novel biological drug, efmedaglutide alfa offers appetite suppression and glucose-dependent glycaemic control. CSPC also submitted an abbreviated NDA for a semaglutide biosimilar in August 2025, reinforcing its position as a key player in China’s fast-growing metabolic disease market.
• The weight-management indication addresses a critical unmet need, with obesity treatment options remaining limited despite prevalence rates exceeding 50% among adults in China.

Qilu Reports First Data for PROTAC AR Degrader in mCRPC

Key Words: PROTAC, AR degrader, mCRPC, Qilu, ESMO 2025

The News: Qilu Pharmaceutical has unveiled initial Phase I data for its proteolysis-targeting chimera (PROTAC) androgen receptor (AR) degrader QLH12016 at the ESMO 2025 congress. The oral candidate achieved a median radiographic progression-free survival (rPFS) of 7.4 months in 36 patients with metastatic castration-resistant prostate cancer (mCRPC). At the 600mg dose level, rPFS extended to 9.0 months, showing activity in both ligand-binding domain wild-type and mutant populations.

Key Highlights:

• Safety data revealed a 91.7% incidence of treatment-related adverse events (TRAEs), with 38.9% being grade three or higher (primarily anaemia and fatigue). No dose-limiting toxicities were observed across the 100mg to 1200mg daily dose range.
• QLH12016 employs a novel PROTAC design, utilizing bifunctional molecules to recruit E3 ubiquitin ligase for AR ubiquitination and proteasomal degradation. This mechanism addresses AR resistance pathways more effectively than traditional receptor antagonists.
• Qilu’s candidate represents an emerging class of protein degraders targeting the limitations of current antiandrogen therapies like enzalutamide and abiraterone in mCRPC, offering new hope in overcoming resistance in advanced prostate cancer.

RemeGen (688331.SS) Files NDA for Telitacicept in IgA Nephropathy in China

Key Words: IgA nephropathy, telitacicept, NDA, RemeGen, BLyS/APRIL

The News: RemeGen has submitted a new drug application (NDA) in China for its BLyS/APRIL dual-target fusion protein telitacicept to treat primary immunoglobulin A (IgA) nephropathy. Phase III results showed a 55% reduction in urinary protein creatinine ratio versus placebo at 39 weeks in a 318-patient randomized double-blind study. The treatment met its primary endpoint with a favourable tolerability profile and has received priority review designation from China’s Centre for Drug Evaluation (CDE).

Key Highlights:

• Telitacicept works by simultaneously inhibiting the BLyS and APRIL cytokines, which drive pathogenic IgA production and immune complex deposition in glomeruli, addressing an unmet need in progressive kidney disease where 30% to 40% of patients progress to end-stage renal disease.
• The candidate already holds approvals for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and myasthenia gravis, while a primary Sjögren’s syndrome NDA was submitted in September 2025.
• With the global IgA nephropathy patient population projected to reach 10.16 million by 2030, including 2.37 million cases in China, telitacicept represents a significant market opportunity as a first-in-class disease-modifying therapy.

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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