This week’s China healthcare highlights include Lynk Pharmaceuticals and Bao Pharmaceuticals advancing IPO plans on HKEX, Crescent Biopharma entering a US$185M oncology partnership with Kelun-Biotech, and Proviva Therapeutics securing US$30M for its PD-1/IL-2 prodrug. Clinical developments feature Pfizer’s zavegepant nasal spray filing in China, Rhegen’s Phase II mRNA shingles vaccine, and Innovent’s approval of picankibart for psoriasis. Other key updates include Transcenta’s positive data on osemitamab in G/GEJ cancer, Apeiron’s promising Phase I results for GTA182 in MTAP-deficient NSCLC, and DualityBio’s FDA IND clearance for ADC DB-1324.

Transactions & BD (In/Out Licensing)

Lynk Pharmaceuticals Submits Application for HKEX IPO

Key Words: Lynk Pharmaceuticals, HKEX, IPO, JAK inhibitors, IsoNova platform, autoimmune diseases

The News: Lynk, a China-based clinical-stage biopharmaceutical company, has submitted a listing application to the Hong Kong Stock Exchange (HKEX). CITIC Securities and CCB International are serving as joint sponsors for the IPO. Founded in 2018, Lynk specializes in the discovery and development of differentiated small-molecule inhibitors targeting autoimmune and inflammatory diseases, with a strong focus on the JAK-STAT signaling pathway.

Key Highlights:

• Pipeline Assets: Lynk’s clinical-stage pipeline is led by LNK01001, a potentially best-in-class second-generation JAK1 inhibitor, and LNK01004, a potentially first-in-class third-generation soft pan-JAK inhibitor. Both assets aim to address autoimmune and inflammatory diseases with improved efficacy and safety profiles.
• Proprietary Technology: Lynk’s IsoNova protein degradation platform is a cornerstone of its R&D strategy. The platform enhances selectivity and safety by degrading inactive isomers and has generated several preclinical candidates targeting STAT6, VAV1, IRAK4, and NEK7. These candidates have potential applications not only in immunology but also in oncology and neurodegenerative diseases.
• Financial Overview: Lynk reported net losses of RMB 259.6 million, RMB 312.3 million, and RMB 145.4 million for 2023, 2024, and the first nine months of 2025, respectively. These losses were primarily attributed to its high R&D expenditures as the company advances its innovative pipeline.

Bao Pharmaceuticals Nears HKEX Listing with RMB 4.9 Billion+ Post-Money Valuation

Key Words: Bao Pharmaceuticals, HKEX, IPO, synthetic biology, recombinant biologics, autoimmune diseases

The News: Bao Pharma has passed the listing hearing of the Hong Kong Stock Exchange (HKEX) and is preparing for its IPO. CITIC Securities and Haitong International Securities Group are serving as joint sponsors. Founded in 2019, Bao Pharma is a clinical-stage biotech company leveraging synthetic biology to develop recombinant biologic drugs targeting conditions with limited treatment options and complex manufacturing processes.

Key Highlights:

• Pipeline Focus: Bao Pharma’s portfolio includes 12 self-developed candidates, with an emphasis on four strategic areas: high-volume subcutaneous delivery, antibody-mediated autoimmune diseases, assisted reproduction, and recombinant biologics. The pipeline is anchored by three core products.
• Financial Performance: The company reported revenues of RMB 6.9 million (2023), RMB 6.2 million (2024), and RMB 4.2 million (H1 2025), primarily from material sales and service fees. Despite the absence of commercially approved products, Bao Pharma incurred net losses of RMB 160 million (2023), RMB 364 million (2024), and RMB 183 million (H1 2025), driven by significant R&D and administrative expenditures.
• Funding and Valuation: Bao Pharma has raised approximately RMB 1.5 billion across six funding rounds. Its December 2024 Series C+ financing resulted in a post-money valuation exceeding RMB 4.9 billion, underscoring strong investor confidence in its pipeline and platform.

Crescent Biopharma (CBIO.O) Announces Transformational Partnership with Kelun-Biotech (6990.HK) and US$185 Million Private Placement

Key Words: Crescent Biopharma, Kelun-Biotech, CR-001, SKB105, ADC, PD-1 x VEGF, oncology

The News: Crescent has announced a strategic partnership with Kelun-Biotech aimed at accelerating the development of next-generation oncology therapeutics. The collaboration focuses on Crescent’s CR-001, a PD-1 x VEGF bispecific antibody, and Kelun-Biotech’s SKB105 (CR-003), an integrin beta-6-directed antibody-drug conjugate (ADC) with a topoisomerase payload. Crescent also announced a US$185 million private placement, expected to close by December 8, 2025, subject to customary conditions, to support clinical milestones and expand its pipeline.

Key Highlights:

• The partnership grants Crescent exclusive rights to research, develop, and commercialize SKB105 (CR-003) outside of Greater China, while Kelun-Biotech receives exclusive rights to CR-001 in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
• The collaboration includes the development of CR-001 and SKB105 as monotherapies, as well as their evaluation in combination therapies. Both companies retain the right to independently develop CR-001 with other proprietary ADC pipeline assets.
• CR-001, a PD-1 x VEGF bispecific antibody, is expected to enter a global Phase 1/2 trial for solid tumors in early 2026, with proof-of-concept data anticipated in Q1 2027. Combination trials of CR-001 and ADCs, including CR-003, are expected to generate initial data by the end of 2027.

Proviva Therapeutics Secures Over US$ 30 Million in Series A+ Financing

Key Words: Proviva Therapeutics, PTX-912, immuno-oncology, Series A+, OrbiMed, PD-1/IL-2 prodrug

The News: Proviva, a China-based clinical-stage biotech, has raised over US$ 30 million in a Series A+ funding round led by OrbiMed. The funding will accelerate the global clinical development of its lead candidate, PTX-912, and advance multiple pre-clinical assets. Proviva specializes in next-generation immuno-oncology therapies, utilizing its proprietary CROSSOVER (cytokine prodrug technology) and MUSICA (multifunctional effector cell activation) platforms to address systemic toxicity and limited precision in immune cell activation commonly observed with conventional therapies.

Key Highlights:

• PTX-912 Clinical Progress: PTX-912, a first-in-class PD-1/IL-2 prodrug fusion protein, is currently in Phase I dose-escalation trials, demonstrating promising safety data and an early confirmed partial response in non-small cell lung cancer (NSCLC). The molecule is designed to minimize systemic toxicity while enhancing tumour-targeted IL-2 delivery and immune cell activation.
• Proprietary Platforms: Proviva leverages its CROSSOVER and MUSICA platforms to develop innovative therapies that overcome the challenges of traditional immuno-oncology approaches.
• Strategic Focus: The financing will support the expansion of clinical development for PTX-912, pre-clinical pipeline advancements, and potential global partnerships.

Hemay Pharmaceuticals Aims for HKEX Listing with RMB 3.9 Billion Post-Money Valuation

Key Words: Hemay Pharmaceuticals, HKEX, IPO, autoimmune diseases, oncology, small-molecule drugs

The News: On December 1, the Hong Kong Stock Exchange (HKEX) disclosed that Ganzhou Hemay Pharmaceuticals Co., Ltd. (“Hemay Pharmaceuticals” or “Hemay”) has submitted its prospectus. SDIC Securities International is the sole sponsor. Founded in 2002, Hemay is a biopharmaceutical company focused on developing small-molecule drugs for autoimmune diseases and cancer.

Key Highlights:

• Hemay’s pipeline includes seven small-molecule candidates, with two core products:
  • Mufemilast: Approved in China for moderate-to-severe plaque psoriasis (Ps) and in Phase III trials for Behçet’s disease (BD). Other trials target ulcerative colitis (UC), atopic dermatitis (AD), and more.
  • Hemay022: A dual-target EGFR/HER2 inhibitor in Phase III trials for advanced ER+/HER2+ breast cancer.
• Funding and Valuation: Hemay has completed seven funding rounds, with a post-money valuation of RMB 3.9 billion after its Series E round. Key investors include Shanghai Qianji Capital, Tigermed Investment, and Efung Capital.

Clinical Development

Pfizer (NYSE: PFE) Files Third-Generation Migraine Nasal Spray in China

Key Words: Pfizer, zavegepant, migraine, CGRP receptor antagonist, nasal spray, NMPA

The News: Pfizer has submitted a new drug application (NDA) to China’s National Medical Products Administration (NMPA) for zavegepant nasal spray, targeting the acute treatment of migraine with or without aura. Zavegepant, a CGRP receptor antagonist, gained US regulatory approval in 2023 as the first nasal spray of its kind for this indication. The submission is backed by positive Phase II/III and Phase III trial results, which demonstrated significantly greater pain relief at 2- and 3-hours post-dose compared to placebo. This is Pfizer’s second CGRP-targeting migraine therapy seeking approval in China, following the approval of the orally disintegrating tablet rimegepant in 2024.

Key Highlights:

• First-in-Class Nasal Spray: Zavegepant is a third-generation CGRP receptor antagonist and the first of its class to offer a non-oral administration route for acute migraine treatment.
• Clinical Efficacy: Phase II/III and Phase III trials showed that zavegepant provided rapid pain relief, with significant efficacy observed at 2- and 3-hours post-dose compared to placebo.
• Strategic Expansion: Following the approval of rimegepant in China in 2024, Pfizer continues to expand its migraine portfolio with zavegepant, addressing an unmet need for patients who experience nausea or vomiting during migraine attacks.

Rhegen Advances mRNA Shingles Vaccine into Phase II

Key Words: Rhegen, RH110, mRNA vaccine, herpes zoster, shingles, Phase II, immunogenicity

The News: Rhegen, a China-based biotech specializing in mRNA technology, has initiated a Phase II clinical trial for RH110, its lyophilised mRNA vaccine targeting herpes zoster (shingles). The randomised, double-blind, multicentre study will assess the vaccine’s immunogenicity and safety in adults aged 40 and above. RH110, administered as a lyophilised injection, exhibited strong safety profiles during Phase I trials. Primary endpoints include geometric mean titres and seroconversion rates of anti-gE and anti-VZV antibodies 30 days post-vaccination.

Key Highlights:

• Phase II Design: The trial focuses on adult participants aged 40+ and will evaluate both the vaccine’s immunogenicity and safety, critical for advancing RH110 as a preventive shingles therapy.
• mRNA Expertise: Rhegen is a leader in mRNA technology, leveraging its proprietary platform to develop innovative treatments for infectious diseases, oncology, and autoimmune disorders.
• Market Potential: RH110 addresses a significant unmet need in the shingles vaccine market by offering a differentiated, lyophilised mRNA-based preventive option.
• Subsidiary Support: Rhegen’s subsidiary, Enobiology, provides end-to-end mRNA development solutions, further strengthening the company’s position as a key player in the mRNA field.

Innovent Biologics (1801.HK) Gains China Approval for Novel Autoimmune Drug Picankibart

Key Words: Innovent, picankibart, IL-23p19, psoriasis, NMPA, autoimmune therapy

The News: Innovent has secured approval from China’s National Medical Products Administration (NMPA) for picankibart injection, a recombinant anti-IL-23p19 subunit monoclonal antibody (mAb) developed for the treatment of moderate-to-severe plaque psoriasis. Picankibart targets the IL-23 signaling pathway to reduce inflammation and has been shown to deliver significant clinical benefits in psoriasis patients.

Key Highlights:

• Clinical Efficacy: Approval is supported by data from the Phase III CLEAR-1 registrational trial, which achieved a global first for IL-23p19 antibodies in Phase III, with over 80% of participants attaining a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) by week 16.
• Dosing Advantage: Picankibart features the longest maintenance dosing interval in its class, requiring administration only once every 12 weeks, offering greater convenience for patients.
• Market Context: Psoriasis affects an estimated 7 million people in China. Picankibart enters a domestic IL-23p19 inhibitor market that already includes products from Johnson & Johnson, China Medical System/Sun Pharma, and Boehringer Ingelheim.

Transcenta Therapeutics (6628.HK) Presents Updated Efficacy Data from Phase I/II Transtar102 Trial at ESMO Asia

Key Words: Transcenta Therapeutics, sometimes, CLDN18.2, PD-L1, G/GEJ cancer, ESMO Asia

The News: Transcenta announced updated efficacy data from the Phase I/II Transtar102 trial of osemitamab combined with nivolumab and CAPOX in first-line Gastric/Gastroesophageal Junction (G/GEJ) cancer. The findings were presented at the ESMO Asia Congress 2025 in Singapore.

Key Highlights:

• Efficacy Data:
  • In 26 patients with CLDN18.2 expression ≥40%, ≥2+, and known PD-L1 CPS, the median PFS was 16.6 months, ORR was 68%, and median DoR was 18 months.
  • Better PFS outcomes were observed in patients with higher CLDN18.2 expression, regardless of PD-L1 CPS level.
• Safety: The safety profile of osemitamab combined with nivolumab and CAPOX was consistent with previously reported data.
• About Osemitamab: Osemitamab is a humanized anti-CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) activity. It has been granted Orphan Drug Designation by the FDA for gastric, gastroesophageal junction, and pancreatic cancers.

Apeiron Therapeutics Presents Promising Phase I Data for GTA182 in MTAP-Deficient NSCLC at ESMO Asia 2025

Key Words: Apeiron Therapeutics, GTA182, PRMT5 inhibitor, MTAP-deficient, NSCLC, ESMO Asia

The News: Apeiron announced promising Phase I clinical trial data for GTA182, an oral brain-penetrant PRMT5 inhibitor, in MTAP-deficient advanced solid tumors. The data was presented at the ESMO Asia Congress 2025 in Singapore, highlighting notable efficacy in non-small cell lung cancer (NSCLC) patients.

Key Highlights:

• Efficacy Results: As of October 9, 2025, 41 patients with MTAP-deficient advanced solid tumors were enrolled in the study. GTA182 demonstrated:
  • An overall ORR of 30.0% and DCR of 83.3%.
  • In the NSCLC subgroup (n=14), an ORR of 57.1% and DCR of 85.7%.
  • Intracranial tumor shrinkage in 2 out of 3 patients with brain metastases, showcasing its brain-penetrant properties.
• Safety Profile: GTA182 was well tolerated, with common treatment-related adverse events including anemia (51.2%), decreased appetite (43.9%), and fatigue (39.0%). Grade ≥3 adverse events were reported in 26.8% of patients.
• Pharmacokinetics and Pharmacodynamics: Drug exposure increased proportionally with dose levels up to 450 mg, and PRMT5 pathway inhibition was confirmed by a 71.8% reduction in plasma SDMA levels at active doses (100-450 mg).
• About GTA182: GTA182 is a brain-penetrant PRMT5 inhibitor designed for MTAP-deficient tumors. It has shown potent anti-tumor activity in preclinical models, including glioblastoma and other MTAP-deficient cancers.

DualityBio’s (9606.HK) ADC DB-1324 Receives FDA IND Clearance for Clinical Trial in the United States

Key Words: DualityBio, DB-1324, FDA IND, ADC, gastrointestinal tumors

The News: DualityBio announced that FDA has cleared the Investigational New Drug (IND) application for its next-generation antibody-drug conjugate (ADC) DB-1324. This clearance allows DualityBio to initiate a phase 1/2 clinical trial in the United States to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1324 in patients with advanced or metastatic gastrointestinal tumors.

Key Highlights:

• Global Development Progress: DB-1324, developed using DualityBio’s proprietary DITAC (Duality Immune Toxin Antibody Conjugates) platform, received prior approvals in October 2025 from Australia’s Human Research Ethics Committee (HREC) and the Therapeutic Goods Administration (TGA).
• Exclusive Licensing Agreement: DualityBio entered an ex-China licensing agreement with GlaxoSmithKline (GSK) in 2024 for the global development of DB-1324.
• About DB-1324: DB-1324 is a next-generation ADC leveraging DualityBio’s DITAC platform, designed to deliver precise antitumor effects while minimizing off-target toxicity. It holds significant promise as a new treatment option for patients with gastrointestinal tumors and other cancers.

Antengene (6996.HK) Announces XPOVIO® Approval in Hong Kong for Two Additional Indications in Multiple Myeloma and Diffuse Large B-Cell Lymphoma

Key Words: Antengene, XPOVIO®, selinexor, XPO1, multiple myeloma (MM), diffuse large B-cell lymphoma (DLBCL)

The News: Antengene announced that the Department of Health of the Hong Kong Special Administrative Region has approved two supplemental New Drug Applications (sNDAs) for XPOVIO® (selinexor). The approvals include:

• Combination therapy (XVd): XPOVIO® with bortezomib and dexamethasone for adult patients with multiple myeloma (MM) who have received at least one prior therapy.
• Monotherapy: XPOVIO® for adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), including cases arising from follicular lymphoma, after at least two prior lines of systemic therapy for patients not eligible for hematopoietic cell transplant.

Key Highlights:

• XPOVIO® is now approved in Hong Kong for three indications, including its previously approved regimen (Xd) for relapsed/refractory multiple myeloma (R/R MM).
• XPOVIO® is the first XPO1 inhibitor approved in Hong Kong, expanding treatment options for MM and DLBCL patients.
• The drug has been approved in ten APAC countries and regions, with national insurance coverage in five markets: Mainland China, Taiwan, Australia, Singapore, and South Korea.
• About XPOVIO®: XPOVIO® (selinexor) is the world’s first oral, selective XPO1 inhibitor with a unique mechanism of action. It offers novel treatment options for patients with significant unmet medical needs in hematological malignancies and solid tumors.

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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