This week’s China healthcare highlights include Pfizer’s US$2.1B licensing deal with Fosun Pharma for an oral GLP-1 agonist, Bao Pharmaceuticals’ 129% surge on its HKEX debut, and Juncell’s Hong Kong IPO filing targeting China’s first TIL therapy. Biocytogen listed on Shanghai’s STAR Market for its antibody discovery platforms, while Formation Bio launched Bleecker Bio with a US$605M deal for Lynk Pharma’s TYK2 inhibitor. Sobi acquired Arthrosi for up to US$1.5B, adding the Phase III gout drug pozdeutinurad. Clinical updates feature InnoCare’s zurletrectinib for NTRK-positive solid tumors, CSPC’s semaglutide obesity filing, Junshi’s progress in myelofibrosis and breast cancer, ImmuneOnco’s strong IMM0306 data in lymphoma, and Innovent’s trispecific antibody IBI3003 for multiple myeloma.

Transactions & BD (In/Out Licensing)

Pfizer (PPE.N) Commits US$ 2.1 Billion for Oral GLP‑1 Candidate from Fosun Pharma (2196.HK)

Key Words: Pfizer, Fosun Pharma, YaoPharma, oral GLP‑1 receptor agonist, YP05002, obesity, T2D, MASH, global licensing deal

The News: Fosun has entered into a global licensing agreement with Pfizer for an oral small‑molecule GLP‑1 receptor agonist, including the lead candidate YP05002. The deal, executed through Fosun’s subsidiary YaoPharma, grants Pfizer exclusive worldwide rights to develop, manufacture, and commercialize the product for all human and animal indications. YaoPharma will complete the ongoing Phase I trial of YP05002 in Australia, after which full development responsibilities will transfer to Pfizer.

Key Highlights:

• Deal Structure: Under the agreement, YaoPharma will receive an upfront payment of US$ 150 million and is eligible for up to US$ 1.935 billion in development, regulatory, and sales‑based milestone payments, bringing the total potential deal value to US$ 2.085 billion. In addition, YaoPharma will receive tiered royalties on future global net sales.
• YP05002, wholly owned and developed by YaoPharma, is an oral small‑molecule GLP‑1R agonist in Phase I clinical development. It is being advanced as a potential treatment for:
  • Long‑term weight management (obesity)
  • Type 2 diabetes (T2D)
  • Metabolic dysfunction‑associated steatohepatitis (MASH)
• Senior executives from YaoPharma and Fosun highlighted the partnership as:
  • External validation of their innovative small‑molecule GLP‑1 capabilities, and
  • A strategic move to leverage Pfizer’s global development and commercial infrastructure to accelerate the worldwide clinical development, regulatory approvals, and patient access for YP05002 and related oral GLP‑1 assets.

China-Based Bao Pharmaceuticals (2659.HK) Soars 129% on HKEX Trading Debut

Key Words: Bao Pharmaceuticals, HKEX, IPO, synthetic biology, recombinant biologics, assisted reproduction

The News: Bao Pharma has commenced trading on the Hong Kong Stock Exchange (HKEX), with its share price opening 129% higher at HKD 60.5, driven by strong pre‑market demand. The listing was supported by cornerstone investments totalling HKD 200.6 million (US$ 25.8 million). Founded in 2019, Bao Pharma is a clinical‑stage biotechnology company focused on developing recombinant biologic drugs using synthetic biology, targeting therapeutic areas with limited treatment options and complex manufacturing requirements.

Key Highlights:

• Bao Pharma’s pipeline includes 12 self‑developed candidates, of which three are core products:
  • SJ02 (Slonva) – the lead asset, approved in China in August 2025 for assisted reproduction; a long‑acting recombinant human follicle‑stimulating hormone carboxyl‑terminal peptide fusion protein (FSH‑CTP).
  • KJ017 – a recombinant human hyaluronidase currently under regulatory review in China.
  • KJ103 – an innovative recombinant immunoglobulin G (IgG)‑degrading enzyme in Phase III clinical development.
• Technology Focus: The company leverages synthetic biology and recombinant biologics to improve manufacturing efficiency and product quality in indications where existing therapies are limited and production is complex.

Juncell Files for Hong Kong IPO, Aims for China’s First TIL Approval

Key Words: Juncell, HKEX, IPO, TIL therapy, GC101, solid tumours, melanoma, NSCLC, cell therapy

The News: Juncell has submitted a listing application to the Hong Kong Stock Exchange (HKEX). The Shanghai‑based company, founded in June 2019, has raised nearly RMB 800 million (US$ 113.2 million) to date. Juncell focuses on developing innovative cell therapies for solid tumours, with a lead candidate that could become China’s first approved tumour‑infiltrating lymphocyte (TIL) therapy.

Key Highlights:

• Lead Asset GC101 is described as the world’s first TIL therapy that does not require high‑intensity lymphodepletion chemotherapy or co‑administration of IL‑2.
  • Currently in pivotal Phase II trials for melanoma, with a BLA submission anticipated in 2026
  • In Phase Ib development for non‑small cell lung cancer (NSCLC)
• Beyond GC101, Juncell’s pipeline includes:
  • GC203 – a genetically modified TIL therapy
  • An endogenous TIL platform in early development, designed to significantly lower manufacturing costs and simplify production
• Juncell aims to tackle the high cost and complexity that have constrained global TIL therapy adoption, by optimizing manufacturing and treatment regimens. The company is targeting a global oncology drug market projected to exceed US$ 700 billion by 2035, positioning its TIL portfolio for both China and international markets.

Biocytogen (2315.HK) Lists on Shanghai’s STAR Market Following Hong Kong Debut

Key Words: Biocytogen, STAR Market, SSE, HKEX, RenMice, human antibody mice, humanised models, antibody discovery

The News: China-based Biocytogen has commenced trading on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange (SSE), becoming one of the few biotech companies to list first in Hong Kong and subsequently in the A‑share market. The company issued 47.5 million shares at RMB 26.68 each, raising approximately RMB 1.3 billion (US$ 180 million). Its share price opened 117% higher at RMB 58, giving Biocytogen a market capitalisation exceeding RMB 25.9 billion (US$ 3.7 billion). The listing attracted strong investor interest, with an oversubscription rate of more than 5,383 times, underscoring market confidence in Biocytogen’s dual‑engine technology platform and its role as an enabler of global drug discovery.

Key Highlights:

• Biocytogen’s core value proposition is built on two proprietary platforms:

• • The RenMice® series of fully human antibody mice, capable of generating authentic human antibody sequences
  • An extensive library of over 1,700‑target humanised mouse models for pre‑clinical efficacy and safety evaluation

• Integrated Discovery and Validation: By combining fully human antibody mice with large‑scale humanised disease models, Biocytogen offers an end‑to‑end solution to accelerate antibody discovery, optimisation, and in vivo validation for pharmaceutical and biotech partners worldwide.
• Biocytogen’s strategy has been commercially validated through:

• • Robust revenue growth, particularly from overseas markets
  • Partnerships with nearly all of the world’s top ten pharmaceutical companies, including recent collaborations with Merck and Gilead Sciences, highlighting its position as a key platform provider in global biologics R&D.

Formation Bio Launches Bleecker Bio with US$ 605 Million Lynk Deal

Key Words: Formation Bio, Bleecker Bio, Lynk Pharmaceuticals, LNK01006, TYK2 inhibitor, CNS, immunology, AI-enabled drug development

The News: Formation Bio has unveiled a new subsidiary, Bleecker Bio, and signed a licensing deal worth up to US$ 605 million in biobucks with Lynk Pharmaceuticals for ex‑Greater China rights to a next‑generation immunology asset. Bleecker Bio will develop Lynk’s allosteric, CNS‑penetrant TYK2 inhibitor LNK01006, following a 10 December announcement.

Key Highlights:

• Deal Structure: Formation’s Bleecker Bio will obtain global rights (excluding Greater China) to LNK01006. In return, China‑based Lynk will receive a minority equity stake in Bleecker Bio, an upfront payment, and development, regulatory and commercial milestone payments for a total potential deal value of up to US$ 605 million, plus tiered royalties on future sales. The new subsidiary is also backed by venture capital firm Pacific Bridge NY.
• Asset Profile – LNK01006: LNK01006 is an allosteric TYK2 inhibitor designed to penetrate the central nervous system (CNS). It is intended to regulate immune‑signaling pathways in the CNS and potentially modify responses associated with multiple autoimmune and inflammatory conditions. Lynk recently secured FDA clearance to initiate first‑in‑human trials, and Formation plans to start a Phase I study in the first half of next year.
• LNK01006 as a prime example of the company’s “Known In New” strategy—applying validated mechanisms to novel areas of high unmet need. Formation in‑licenses or acquires all of its pipeline assets and leverages artificial intelligence, robust clinical data sets, and internal expertise to:

• • Address bottlenecks in clinical development
  • Improve trial efficiency and affordability
  • Identify novel therapeutic applications for clinically de‑risked asset classes

Sobi (SOBI.ST) to Acquire Arthrosi Therapeutics, Adding Phase III Gout Asset Pozdeutinurad

Key Words: Sobi, Arthrosi Therapeutics, acquisition, pozdeutinurad, AR882, URAT1 inhibitor, gout, Phase 3

The News: Sobi has entered into a definitive agreement to acquire Arthrosi, a private late‑stage biotech focused on next‑generation gout treatments. The deal adds pozdeutinurad (AR882), an oral once‑daily URAT1 inhibitor currently in two fully enrolled global Phase III trials for progressive and tophaceous gout, with pivotal readouts expected in 2026. The acquisition is expected to be highly accretive to Sobi’s mid‑ to long‑term growth and margin profile.

Key Highlights:

• The transaction expands Sobi’s gout franchise with a highly differentiated, late‑stage asset positioned as a potentially best‑in‑class URAT1 inhibitor for patients inadequately controlled on first‑line therapies. Pozdeutinurad is intended to improve serum uric acid control, dissolve tophi, and address persistent symptoms in progressive and tophaceous gout, reinforcing Sobi’s commitment to advancing treatment options for people living with gout.
• Transaction Structure and Financing:

• • Upfront consideration: US$ 950 million (approx. SEK 9.1 billion) in cash.
  • Milestones: Up to US$ 550 million (approx. SEK 5.3 billion) in clinical, regulatory, and sales‑based milestones.
  • The deal is subject to customary closing conditions and is expected to close in H1 2026.
  • Sobi plans to fund the upfront payment mainly through debt, drawing on existing credit lines and a new facility provided by Handelsbanken and Danske Bank.
  • The acquisition is expected to be highly accretive to Sobi’s mid‑ to long‑term growth and margins.

• Pozdeutinurad is an investigational, highly potent and selective next‑generation URAT1 inhibitor being developed for progressive and tophaceous gout:

• • Phase II data showed compelling efficacy, including sustained reduction in serum uric acid (sUA), dissolution of tophi, and a well‑tolerated safety profile.
  • Currently in two global Phase III trials—REDUCE 1 and REDUCE 2—both 12‑month, randomized, double‑blind, placebo‑controlled studies evaluating its ability to reduce sUA in patients with progressive and tophaceous gout.
  • Both Phase III studies are fully enrolled, with pivotal data expected in 2026.
  • Rights to pozdeutinurad in Greater China are held by ApicHope.

• About Arthrosi: Arthrosi headquartered in San Diego, California, is a late‑stage biotechnology company focused on developing pozdeutinurad as a next‑generation URAT1 inhibitor to reduce serum urate, flares, and tophi in patients with progressive gout. The acquisition brings Arthrosi’s team and late‑stage gout expertise into Sobi’s expanding specialty and rare disease portfolio.

Clinical

InnoCare (9969.HK) Advances Zurletrectinib as First Solid-Tumor Therapy and Prepares Pediatric NDA in China

Key Words: InnoCare, zurletrectinib, NTRK fusion, solid tumors, SPARK Program, pediatric, NMPA

The News: InnoCare announced that zurletrectinib, its third innovative drug and first solid‑tumor therapy, has been approved in China for NTRK fusion–positive solid tumors. The company plans to submit a new drug application (NDA) for pediatric patients aged 2–12 in the near future.

Key Highlights:

• Zurletrectinib is of significant clinical importance for NTRK fusion–positive solid tumor patients and enables earlier access to a new treatment option in China.
• Zurletrectinib has been included in the NMPA’s “SPARK Program”, a pilot initiative to promote pediatric anti‑tumor drugs, supporting InnoCare’s planned pediatric NDA.
• NTRK fusion genes have been identified in over 26 solid tumors, with an estimated 6,500 new NTRK fusion–positive cases annually in China. Patients often face rapid progression and poor outcomes, while limited use of NGS testing contributes to delayed diagnosis and substantial unmet clinical need.
• About InnoCare: InnoCare is a commercial‑stage biopharmaceutical company focused on first‑/best‑in‑class therapies for cancers and autoimmune diseases, with operations in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.

CSPC Pharmaceutical Group (1093.HK) Files New Semaglutide Indication in China, Widely Seen as Targeting Obesity

Key Words: CSPC, semaglutide, obesity, type 2 diabetes, NMPA, synthetic peptide, China

The News: CSPC Pharma has submitted a new drug application (NDA) to China’s National Medical Products Administration (NMPA) for an additional indication of its semaglutide injection, widely believed by industry analysts to be for the treatment of obesity. This follows CSPC’s initial NDA for type 2 diabetes (T2D) filed in August 2025 and comes after completion of a Phase III obesity trial in September 2025.

Key Highlights:

• Regulatory and Clinical Status:

• • Initial NDA for T2D submitted in August 2025.
  • A Phase III clinical trial in obesity was completed in September 2025, providing the clinical basis for the current filing.
  • The latest NDA is viewed by industry as CSPC’s move to formally enter the weight‑management / obesity market with semaglutide.

• CSPC emphasizes that its semaglutide is produced via a fully synthetic chemical process, rather than biological fermentation:

• • Achieves high product purity.
  • Avoids potential immunogenic substances associated with biologically derived products.
  • Maintains impurity levels comparable to or lower than recombinant DNA (rDNA)‑produced semaglutide.

• Pre‑clinical data reported by CSPC indicate that the synthetic semaglutide shows:

• • Similar biological activity to the originator biologic.
  • Comparable weight‑loss efficacy and metabolic profile.
  • A similar safety profile, supporting its use in T2D and obesity indications.

Junshi Biosciences (1877.HK) Posts Positive Early Data for JS110 in Myelofibrosis and Toripalimab in HR+/HER2- Breast Cancer

Key words: Junshi Biosciences, JS110, XPO1 inhibitor, myelofibrosis, JAK inhibitor, ruxolitinib, toripalimab, HR+/HER2- breast cancer, neoadjuvant therapy, ASH 2025, SABCS 2025

The News: Junshi reported positive early-stage clinical data for two key oncology assets at the 2025 ASH and SABCS meetings, highlighting progress in both hematologic malignancies and solid tumors.

• At the 2025 ASH meeting, Junshi presented preliminary Phase I results for JS110, an XPO1 inhibitor, in myelofibrosis (MF) patients previously treated with JAK inhibitors.
• At SABCS 2025, the company disclosed preliminary Phase II data from the NEOTORCH-BREAST01 study, assessing toripalimab plus neoadjuvant chemotherapy in HR+/HER2- breast cancer.

Key Highlights

• JS110 in Myelofibrosis (Phase I, ASH 2025)

• • JS110 (monotherapy and in combination with ruxolitinib) showed good tolerability in JAK inhibitor–treated MF patients, with no dose-limiting toxicities and mostly Grade 1–2 TEAEs, mainly mild gastrointestinal events.
  • In the 60 mg combination cohort, 100% of patients achieved SVR25 and 66.7% achieved SVR35, with responses sustained beyond 48 weeks.
  • TSS50 was reached in 100% of patients in this group, alongside rapid and durable reductions in WBC and LDH, supporting further development; Phase II trials are ongoing.

• Toripalimab in HR+/HER2- Breast Cancer (Phase II, SABCS 2025)

• • In the NEOTORCH-BREAST01 study, toripalimab plus neoadjuvant chemotherapy followed by surgery and adjuvant toripalimab plus endocrine therapy yielded a pCR rate of 44.9% (13/29) and an RCB 0/1 rate of 65.5% (19/29).
  • Subgroup analysis showed enhanced efficacy in patients with PD-L1 CPS ≥ 10 (11/15 achieved pCR) and in those with higher TILs, suggesting an immunologically enriched population may derive greater benefit.
  • Safety was manageable and consistent with known profiles, with 37.9% of patients experiencing Grade ≥ 3 TRAEs; long-term follow-up is planned to evaluate survival outcomes.

ImmuneOnco Biopharmaceuticals (1541.HK) Reports Strong Phase I/II Data for IMM0306 Plus Lenalidomide in R/R Follicular Lymphoma

Key words: ImmuneOnco, IMM0306, amulirafusp alfa, CD47, CD20, lenalidomide, relapsed/refractory follicular lymphoma, ASH 2025, Phase I/II, Phase III

The News: ImmuneOnco reported positive Phase I/II results for amulirafusp alfa (IMM0306) in combination with lenalidomide in relapsed/refractory CD20-positive follicular lymphoma (R/R FL) at the 2025 ASH Annual Meeting. The IMM0306–lenalidomide combination delivered high response rates, encouraging short-term PFS and a favorable safety profile with no CRS observed. Based on these data, a Phase III clinical trial of IMM0306 plus lenalidomide in R/R FL has been approved by the CDE.

Key Highlights

• Efficacy (overall and high-risk subgroups):

• • Among 34 evaluable patients who had failed at least one prior anti-CD20 monoclonal antibody treatment, the combination achieved an objective response rate (ORR) of 91.2% and a complete response (CR) rate of 67.6%.
  • In the high-risk anti-CD20 refractory subgroup (18 patients), the regimen delivered a ORR of 88.9% and a CR rate of 66.7%, indicating robust activity even in heavily pretreated, refractory disease.
  • The 6‑month progression-free survival (PFS) rate was 91.2%, suggesting early signals of durable disease control.

• Safety profile:

• • Across 47 patients, the safety profile of IMM0306 plus lenalidomide was generally manageable.
  • Importantly, no cytokine release syndrome (CRS) was observed, representing a notable safety advantage for a CD47‑targeting therapy, where CRS is typically a key concern.

• These Phase I/II results support further development in Phase III to confirm the benefit–risk profile of IMM0306 plus lenalidomide and potentially establish a new treatment option for patients with R/R FL.

Innovent Biologics (1801.HK) Presents First-in-Human Phase I Data for Trispecific Antibody IBI3003 in R/R Multiple Myeloma at ASH 2025

Key words: Innovent, IBI3003, trispecific antibody, GPRC5D, BCMA, CD3, relapsed/refractory multiple myeloma, R/R MM, ASH 2025, Phase I

The News: Innovent reported initial results from the first-in-human Phase I study of IBI3003, a trispecific antibody targeting GPRC5D, BCMA and CD3, in relapsed/refractory multiple myeloma (R/R MM) at the 2025 ASH Annual Meeting. IBI3003 showed a manageable safety profile and encouraging early efficacy, including in high-risk patients with extramedullary disease (EMD) or prior anti-BCMA and/or anti-GPRC5D therapies. Dose optimization is ongoing.

Key Highlights

• Study design and patients:

• • Ongoing Phase 1/2 trial (NCT06083207) in China and Australia; IBI3003 given subcutaneously weekly with step-up priming doses, with option to move to Q2W maintenance after sustained response.
  • Phase I enrolled 39 R/R MM patients (median 4 prior lines), all exposed to PI, IMiD and anti-CD38; 64.1% high-risk, 46.2% with EMD, 41% with prior anti-BCMA and/or anti-GPRC5D; 76.9% refractory to last regimen. Median follow-up was 3.25 months.

• Safety profile:

• • DLTs in 2 patients (Grade 4 thrombocytopenia), both recovered.
  • 97.4% had TEAEs; common events included CRS and cytopenias. Hematologic Grade ≥3 TEAEs were mainly during step-up and were manageable.
  • CRS and ICANS incidences were 64.1% and 6.1%, all Grade 1–2 and resolved; prophylactic tocilizumab may further mitigate CRS.
  • Infections occurred in 48.7% of patients (Grade ≥3: 28.2%); GPRC5D-related oral, skin and nail events were mostly Grade 1–2, with only 2 Grade 3 rashes and no Grade ≥3 oral events.

• Efficacy and pharmacodynamics (doses ≥120 μg/kg):

• • Among 24 patients treated at ≥120 μg/kg, ORR was 83.3% (4 sCR, 7 VGPR, 9 PR).
  • ORR was 80% in 10 patients with EMD and 77.8% in 9 patients with prior anti-BCMA and/or anti-GPRC5D therapy.
  • MRD negativity was 100% (4/4) among patients achieving CR or better.
  • Strong pharmacodynamic activity was evidenced by a profound, durable decline in soluble BCMA across key dose levels.

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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