This week’s China healthcare updates highlight advancements across IPOs, licensing deals, radiopharmaceutical innovation, and clinical milestones. TenNor Therapeutics achieved over 120x margin subscription ahead of its HKEX IPO, spotlighting its antibacterial Rifasutenizol. Full-Life Technologies and Bivision raised RMB 1B+ and RMB 400M, respectively, driving radiopharmaceutical pipelines targeting mCRPC and solid tumors. Henlius Biotech in-licensed EGFR-TKI FHND9041 with first-line NSCLC data showing 26.05-month PFS, while TransThera Sciences secured HK$152M to advance cholangiocarcinoma therapy Tinengotinib. Rongcan Bio’s therapeutic HPV mRNA vaccine became the first domestic candidate accepted by China’s CDE, and Hengrui’s HER3 ADC SHR-A2009 met its Phase III endpoint in NSCLC. MediLink reported the first positive Phase III readout for a B7-H3 ADC, CSPC gained approval for budesonide capsules in IgA nephropathy, and Akeso’s PD-1/VEGF bispecific ivonescimab achieved global prominence with OS data for squamous NSCLC at ASCO 2026. These milestones emphasize China’s growing leadership in pharmaceutical innovation, global partnerships, and breakthrough therapies.

Transactions & BD (In/Out Licensing)

TenNor Therapeutics (6872.HK) IPO Receives Over 120x Margin Subscription Ahead of HKEX Listing

Key Words: TenNor Therapeutics, HKEX, IPO, margin subscription, antibacterial therapies, microbiome metabolism

• The News: TenNor Therapeutics closed its Hong Kong public offering with margin subscription reportedly exceeding 120x ahead of its planned HKEX listing on May 22, 2026. The company plans to offer 8.28 million H shares at HK$ 75.70 per share.
• Key Highlights:
• Deal Details:
  • Offering size: 8.28 million H shares.
  • Offer price: HK$ 70 per H share.
  • Margin subscription: Reportedly exceeded 120x.
• Product Profile – Rifasutenizol:
  • Rifasutenizol: A triple-target antibacterial candidate being developed for Helicobacter pylori infection and other bacterial infections.
  • Indication: Helicobacter pylori infection and other bacterial infections.
  • Mechanism: Dual-targeted approach that disrupts bacterial protein synthesis and has strong bactericidal properties even against persistent “coccoid” forms of the bacteria
  • Highly effective against multidrug-resistant strains while producing fewer adverse events than traditional therapies.
• TenNor Therapeutics is a China-based biotech focused on differentiated therapies for bacterial infections and microbiome-metabolism-related diseases.

Full-Life Technologies Raises Over RMB 1 Billion to Advance Radiopharmaceutical Pipeline and Belgium Manufacturing Site

Key Words: Full-Life Technologies, financing, Vivo Capital, SK Biopharmaceuticals, radiopharmaceuticals, actinium-225, FL-020, FL-261, UniRDC

• The News: Full-Life Technologies completed over RMB 1 billion in financing, including approximately RMB 750 million in Series D equity financing and RMB 270 million in debt financing. The round was led by Vivo Capital, with participation from SK Biopharmaceuticals and existing investors including Chengwei Capital, Sequoia China, Janchor Partners, LYFE Capital, Plaisance, Sky9 and TSG Capital.
• Key Highlights:
• Deal Details:
  • Financing size: Over RMB 1 billion, including approximately RMB 750 million Series D equity financing and RMB 270 million debt financing.
  • Lead investor: Vivo Capital.
  • Advance clinical-stage radiopharmaceutical pipeline development and support GMP-grade actinium-225 production at the company’s Belgium manufacturing facility.
• Product Profile – [225Ac]Ac-FL-020:
  • [225Ac]Ac-FL-020: A best-in-class PSMA-targeted actinium-225 radioligand therapy being developed for metastatic castration-resistant prostate cancer (mCRPC).
  • Currently in global Phase I clinical development and granted FDA Fast Track Designation.
  • Mechanism: Designed to deliver alpha-emitting actinium-225 selectively to PSMA-expressing prostate cancer cells, aiming to induce targeted tumor cell killing while limiting systemic exposure.
  • Clinical data: In preclinical models, radiolabeled FL-020 showed sustained tumor uptake, rapid systemic clearance and anti-tumor activity in LNCaP xenograft models; early Phase I data have shown a favorable safety profile.
• Full-Life Technologies is a private clinical-stage radiopharmaceutical company, focused on integrated radiopharmaceutical discovery, development and manufacturing.

Bivision Raises Nearly RMB 400 Million in Series B Financing to Advance Targeted Radiopharmaceutical Pipeline

Key Words: Bivision, Series B financing, targeted radionuclide therapy, TRT, radiopharmaceuticals, JH02, JH04, theranostics

• The News: Bivision completed nearly RMB 400 million in Series B financing to support confirmatory clinical development of its core pipeline, platform iteration and expansion of differentiated radiopharmaceutical programs. The round was co-led by Pudong Venture Capital, Zhangjiang Technology Investment and IDG Capital, with participation from existing investor Gaorong Ventures and other institutions.
• Key Highlights:
• Deal Detail:
  • Financing size: Nearly RMB 400 million Series B financing.
  • Lead investors: Pudong Venture Capital, Zhangjiang Technology Investment and IDG Capital.
• Core Product – JH02:
  • JH02: A targeted radionuclide therapy candidate for solid tumors, designed as an integrated theranostic radiopharmaceutical.
  • Mechanism: Designed to combine tumor-targeting molecular recognition with radionuclide-mediated radiation delivery, enabling integrated tumor imaging and targeted tumor cell killing.
  • Clinical stage: Proceeds from the Series B financing will support confirmatory clinical development of JH02.
• Bivision is a China-based biotech focused on targeted radionuclide therapy and theranostic radiopharmaceutical development.

Henlius Biotech (2696.HK) In-Licenses China Commercial Rights to Third-Generation EGFR-TKI FHND9041

Key Words: Henlius Biotech, Chia Tai Fenghai, Jiangsu Chuangte, FHND9041, aumolertinib, EGFR-TKI, NSCLC, commercialization rights, licensing

• The News: Henlius Biotech entered into a strategic collaboration with Chia Tai Fenghai and its subsidiary Jiangsu Chuangte for FHND9041, an oral third-generation EGFR-TKI developed by Jiangsu Chuangte. Henlius will obtain exclusive commercialization and development rights in mainland China and Macau across all human disease indications, as well as priority cooperation rights in the U.S. and Japan.
• Key Highlights:
• Deal Detail:
  • Financial terms: Jiangsu Chuangte will receive upfront payment, sales milestones and tiered royalties based on future product sales.
  • Rights granted: Exclusive commercialization and development rights for all human disease indications.
• Product Profile – FHND9041:
  • FHND9041: An oral third-generation EGFR-TKI being developed for first-line treatment of EGFR exon 19 deletion NSCLC.
  • China NDA accepted by CDE in February 2026.
  • Mechanism: Designed to selectively inhibit EGFR-mutant signaling, including third-generation EGFR-TKI-sensitive mutations, with reported high brain penetration and lung-targeted distribution.
• Clinical Data:
  • Phase III study: Registrational Phase III trial in first-line EGFR 19del NSCLC met its primary endpoint.
  • Efficacy: BICR-assessed median PFS reached 26.05 months, extending PFS by 9.52 months versus control.
  • In a Phase I/II study after EGFR-TKI progression, FHND9041 showed cORR of 49.5%, DCR of 96.3%, median PFS of 15.1 months, mDOR of 19.4 months and mOS of 29.8 months.
  • Safety: Most adverse events were Grade 1-2; no patient required dose reduction, interruption or discontinuation due to QT prolongation.

TransThera Sciences (2617.HK) Raises HK$ 152 Million Through Discounted H-Share Placement

Key Words: TransThera Sciences, HKEX, H-share placement, Tinengotinib, biotech financing, cholangiocarcinoma

• The News: TransThera Sciences announced an H-share placement of 3.836 million new shares at HK$ 40.83 per share, representing an 18.01% discount to the previous closing price. The company expects to raise net proceeds of approximately HK$ 152 million to support development of new indications for Tinengotinib.
• Key Highlights:
• Deal Details:
  • Placement size: 3.836 million new H shares.
  • Placement price: HK$40.83 per share, approximately 18.01% to the previous closing price of HK$ 49.8.
  • Net proceeds: Approximately HK$ 152 million.
  • Approximately 90% for development of new indications of Tinengotinib and 10% for working capital and general corporate purposes.
• Product Profile – Tinengotinib:
  • Tinengotinib: A multi-kinase inhibitor being developed for cholangiocarcinoma and other solid tumors, with a Phase III study initiated in April 2026.
  • Mechanism: Targeting tumor growth and resistance-related signaling pathways.
  • Clinical data: Achieved an ORR of 30%, DCR of 93% and median PFS of 6.0 months in FGFR inhibitor-pretreated cholangiocarcinoma patients.
• TransThera Sciences is a Hong Kong-listed clinical-stage biotech focused on developing small-molecule therapies for oncology, inflammatory and fibrotic diseases.

Longbio Pharma Clears HKEX Listing Hearing

Key Words: Longbio Pharma, HKEX, IPO, autoimmune diseases, allergic diseases, IgE antibody, C5/C3b bispecific antibody

• The News: On May 21, 2026, Longbio Pharma, a clinical-stage biopharma company based in Changshu, Suzhou, Jiangsu Province, announced the disclosure of its post-hearing IPO prospectus on the Hong Kong Stock Exchange (HKEX). The company is set to list on the main board after filing in August 2025 and February 2026. Longbio focuses on innovative biologics for allergic and autoimmune diseases, leveraging its proprietary high-affinity antibody discovery and bispecific antibody platforms.
• Key Highlights:
• LP-003: A next-generation anti-IgE antibody with best-in-class potential designed for allergic diseases, including allergic rhinitis (AR), chronic spontaneous urticaria (CSU), and allergic asthma.
  • Phase III trial for seasonal AR in China; BLA submission expected by Q3 2026.
  • Phase II head-to-head trial vs. omalizumab for CSU; Phase III to follow in H1 2026.
  • Phase II trial for allergic asthma ongoing; additional trials for other allergic diseases to begin in Q4 2026.
  • Market Outlook: According to Frost & Sullivan, LP-003 is the most advanced next-generation anti-IgE therapy globally.
• LP-005: A bispecific antibody targeting C5 and C3b designed for complement-mediated diseases such as paroxysmal nocturnal hemoglobinuria (PNH), IgA nephropathy (IgAN), lupus nephritis (LN), and others.
  • Phase II trial for PNH ongoing in China.
  • Phase II trials for complement-mediated kidney diseases to begin in 2026.
  • Exploratory studies planned for other complement-mediated diseases, including generalized myasthenia gravis (gMG) and ALS.
• Pipeline Expansion, developing additional bispecific antibodies for allergic and autoimmune diseases:
  • LP-00A: Dual-function antibody for allergic diseases.
  • LP-00C: B-cell inhibitor for autoimmune diseases.
  • LP-00D: Complement-focused bispecific antibody for specific organ-related conditions.
• About Longbio Pharma: Established in 2020, Longbio Pharma focuses on innovative biologics for allergic and autoimmune diseases, supported by proprietary technology platforms and strong R&D capabilities.

Whitehawk Therapeutics Partners (WHWK.O) with DAC Biotechnology on Cross-Border ADC Collaboration

Key Words: Whitehawk Therapeutics, DAC Biotechnology, ADC, CPT113, CrossConju™, strategic BD agreement

• The News: On May 22, 2026, Whitehawk Therapeutics, a U.S.-based biopharma company, and Hangzhou DAC Biotechnology announced a new strategic collaboration. Under this agreement, Whitehawk will develop up to five novel antibody-drug conjugates (ADCs) utilizing DAC’s proprietary CPT113 linker-toxin and CrossConju™ site-specific conjugation technology. DAC retains the right to receive milestone payments and sales royalties under future licensing agreements for these products.
• Key Highlights:
• Collaboration Background:
  • This marks the second partnership between the two companies. In December 2024, DAC out-licensed global rights to three ADC candidates developed on its CPT113 platform to Whitehawk through WuXi Biologics.
  • Of the three, two ADC candidates are currently in clinical trials, with the third nearing clinical entry.
• Proprietary Technology:
  • CPT113: A Topo 1 inhibitor-based linker-toxin technology.
  • CrossConju™: A site-specific conjugation method for precision ADC development. Both have been clinically validated in multiple collaborations and in-house programs.
• About DAC Biotechnology: With years of cross-border collaboration experience, DAC is advancing its proprietary ADC platform technologies while actively pursuing external partnerships and accelerating clinical development of its internal pipeline.

Clinical

Rongcan Bio’s Therapeutic HPV mRNA Vaccine Accepted by China CDE

Key Words: Rongcan Bio, therapeutic HPV vaccine, mRNA vaccine, HPV16, LNP delivery, CDE, cervical cancer

• The News: Rongcan Bio’s therapeutic HPV mRNA vaccine has been accepted by China’s CDE for clinical trial review, becoming the first domestic therapeutic HPV mRNA vaccine to reach this regulatory stage in China. The candidate previously reported early IIT data in persistent HPV16 infection.
• Key Highlights:
• Clinical Data:
  • IIT study enrolled 9 patients with persistent HPV16 infection for more than one year.
  • Efficacy: 8 of 9 patients achieved complete HPV clearance at 3 months after treatment, corresponding to an 88% negative conversion rate.
  • Safety: No Grade ≥2 adverse events were reported.
• Drug Profile – Therapeutic HPV mRNA Vaccine:
  • Indication: Persistent HPV16 infection and HPV-associated cervical precancerous lesions.
  • Mechanism: Designed to induce HPV-specific cellular immune responses to recognize and eliminate HPV-infected cells.
  • Development stage: Accepted by China CDE for clinical trial review; previously cleared by the U.S. FDA for clinical study in March 2025.
• Rongcan Bio is a China-based biotech focused on nucleic acid therapeutics, with proprietary mRNA and LNP delivery technology platforms spanning vaccine and gene therapy applications.

Hengrui’s (600276.SH) HER3 ADC SHR-A2009 Meets Primary Endpoint in Phase III NSCLC Trial

Key Words: Hengrui, SHR-A2009, HER3 ADC, EGFR-mutant NSCLC, EGFR TKI resistance, Phase III, PFS

• The News: Hengrui Medicine announced that SHR-A2009 met the primary endpoint at interim analysis in a randomized, open-label, multicenter Phase III trial in EGFR-mutant advanced or metastatic NSCLC after EGFR TKI failure. SHR-A2009 significantly improved PFS versus platinum-based doublet chemotherapy. The company plans to submit a pre-NDA communication request to China CDE.
• Key Highlights:
• Clinical Data:
  • Study design: Phase III trial enrolled 498 patients across 65 centers, randomized 1:1 to SHR-A2009 monotherapy or platinum-based doublet chemotherapy.
  • Primary endpoint: BICR-assessed PFS.
  • Efficacy: Significantly prolonged PFS v platinum-based doublet chemotherapy at interim analysis.
• Drug Profile – SHR-A2009:
  • SHR-A2009: A HER3-targeted ADC composed of a fully human HER3 monoclonal antibody conjugated to a DNA topoisomerase I inhibitor payload.
  • Indication: EGFR-mutant advanced or metastatic NSCLC after EGFR TKI resistance, with first-line EGFR-mutant NSCLC also in Phase III development.
  • Mechanism: Designed to bind HER3-expressing tumor cells, internalize and release a TOPO1 inhibitor payload to induce DNA damage and tumor cell death.
  • First Phase III study met primary endpoint; pre-NDA communication with China CDE planned.

Vincentage Pharma’s Oral GLP-1 Agonist VCT220 Reports Positive Phase III Topline Results in Weight Management

Key Words: Vincentage Pharma, VCT220, oral GLP-1 receptor agonist, obesity, overweight, weight management, Phase III, NDA

• The News: Vincentage Pharma announced positive topline results from a pivotal Phase III trial of VCT220, its once-daily oral small-molecule GLP-1 receptor agonist, in Chinese adults with obesity or overweight plus at least one weight-related comorbidity. The company plans to submit an NDA for the weight management indication to China’s NMPA.
• Key Highlights:
• Clinical Data:
  • Study design: Pivotal Phase III study enrolled 840 adults with obesity or overweight plus at least one weight-related comorbidity, randomized 1:1:1 to VCT220 120mg, VCT220 160mg or placebo once daily for 52 weeks.
  • Efficacy: At Week 52, mean body weight reductions were 12.2% for VCT220 120mg and 12.4% for VCT220 160mg, v 1.3% for placebo.
  • Safety: Treatment-related discontinuation rates were 1.8% in both VCT220 dose groups; common adverse events were mainly gastrointestinal and mostly Grade 1-2.
  • No Grade ≥3 nausea or vomiting and no liver safety signal were reported.
• Drug Profile – VCT220:
  • VCT220: A once-daily oral, non-peptide small-molecule GLP-1 receptor agonist being developed for weight management in adults with obesity or overweight.
  • Mechanism: Designed to activate the GLP-1 receptor to reduce appetite, improve glucose metabolism and support body weight reduction.
  • Corxel Pharmaceuticals holds ex-Greater China rights and is developing VCT220 as CX11 in U.S. Phase II obesity and global Phase II type 2 diabetes studies.
• Vincentage Pharma is a clinical-stage Chinese biotech company developing novel small-molecule drugs for metabolic diseases like obesity, type 2 diabetes, and MASH.

CSPC’s (1093.HK) Budesonide Enteric-coated Capsules Approved in China for IgA Nephropathy

Key Words: CSPC, budesonide enteric-coated capsules, IgA nephropathy, IgAN, NMPA approval, renal disease

• The News: CSPC Pharmaceutical Group announced that its budesonide enteric-coated capsules 4mg received drug registration approval from China’s NMPA for the treatment of adults with primary IgA nephropathy at risk of disease progression, aiming to reduce kidney function loss. The approval further expands CSPC’s nephrology portfolio and introduces another domestic budesonide-based option into China’s IgAN market, following the commercial validation of Everest Medicines’ Nefecon.
• Key Highlights:
• Regulatory Milestone:
  • Approval: Received NMPA approval for budesonide enteric-coated capsules 4mg.
  • Indication: Adults with primary IgA nephropathy at risk of disease progression, to reduce kidney function loss.
• Drug Profile – Budesonide:
  • Budesonide: A corticosteroid with strong glucocorticoid activity and weak mineralocorticoid activity.
  • Administration: Oral enteric-coated capsule, 4mg.
  • Suppressed mucosal B-cell proliferation and plasma-cell differentiation in Peyer’s patches in the ileum, reducing production of galactose-deficient IgA1 and downstream immune-complex deposition in the kidney.
  • Differentiation: Uses delayed-release / sustained-release formulation design to target intestinal immune tissue, with lower systemic exposure and improved safety profile versus broader systemic corticosteroid exposure.

MediLink’s B7-H3 ADC YL201 Hits Phase III ORR Endpoint in Nasopharyngeal Cancer

Key Words: MediLink Therapeutics, YL201, tam-peli, B7-H3 ADC, nasopharyngeal carcinoma, Phase III, Roche

• The News: MediLink Therapeutics announced that its B7-H3 ADC YL201 / tam-peli met one of the co-primary endpoints in a pre-planned interim analysis of the Phase III TAISHAN-301 study for recurrent or metastatic nasopharyngeal carcinoma. The study achieved a positive result in BICR-assessed objective response rate, while the other co-primary endpoint, overall survival, remains immature. This marks the first positive Phase III result reported for a B7-H3 ADC.
• Key Highlights:
• Clinical Data:
  • Study design: TAISHAN-301 is a randomized, controlled, multicenter Phase III study in recurrent or metastatic nasopharyngeal carcinoma.
  • Primary endpoint: YL201 met one co-primary endpoint of BICR-assessed ORR at the pre-planned interim analysis.
  • OS Status: The other co-primary endpoint, overall survival, remains immature.
  • Significance: First reported positive Phase III readout for a B7-H3 ADC.
  • Clinical Stage: Three Phase III registrational studies are ongoing in China for nasopharyngeal carcinoma, small cell lung cancer and esophageal squamous cell carcinoma.
• Drug Profile – YL201 / tam-peli:
  • YL201 / tam-peli: A B7-H3-targeting antibody-drug conjugate.
  • Mechanism: The ADC targets B7-H3-expressing tumor cells and delivers a camptothecin-based cytotoxic payload through MediLink’s tumor microenvironment-cleavable linker platform, TMALIN®.
  • Indication: Recurrent / metastatic nasopharyngeal carcinoma, with broader development across multiple solid tumors.
• MediLink Therapeutics is a China-based biotech focused on developing next-generation ADC therapies for solid tumors, with core capabilities in linker-payload design, tumor-targeted delivery and global oncology drug development.

Akeso (9926.HK) and Summit (SMMT.O) Present Ivonescimab OS Data in 1L Squamous NSCLC at ASCO 2026

Key Words: Akeso, Summit Therapeutics, ivonescimab, PD-1/VEGF bispecific antibody, squamous NSCLC, ASCO 2026, HARMONi-6, tislelizumab

• The News: Akeso and Summit Therapeutics presented data from a head-to-head study evaluating ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer. The study was selected as a Late-Breaking Abstract / LBA4 at the ASCO 2026 plenary session, highlighting the global attention around PD-1/VEGF bispecific antibodies as a next-generation immuno-oncology strategy.
• Key Highlights:
• Clinical Data:
  • Study: HARMONi-6 / LBA4, evaluating ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in first-line advanced squamous NSCLC.
  • Readout focus: The ASCO 2026 presentation focused on overall survival data, following prior evidence of PFS benefit for ivonescimab-based regimens.
  • Phase III study: Significantly improved PFS vs. pembrolizumab, reducing the risk of disease progression or death by 49%; median PFS was 11.14 months with ivonescimab vs. 5.82 months with pembrolizumab.
  • Clinical significance: OS is the key endpoint to validate whether ivonescimab’s PFS benefit can translate into a more meaningful survival advantage in first-line squamous NSCLC.
• Drug Profile – Ivonescimab:
  • Ivonescimab: A first-in-class PD-1/VEGF bispecific antibody.
  • Mechanism: Combine immune checkpoint blockade through PD-1 inhibition with anti-angiogenic activity through VEGF-A blockade, aiming to enhance antitumor immunity while suppressing tumor vascular growth.
  • Indication: Non-small cell lung cancer, including first-line squamous NSCLC and other advanced NSCLC settings.
  • Administration: Intravenous infusion.

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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