This week’s China healthcare highlights include Novlead Biotechnology filing for a Chapter 18A IPO on HKEX, Everest Medicines signing an LOI to acquire Haisco’s Singapore unit, and Excalipoint Therapeutics closing a US$ 68.7M seed round for TCE platforms. R1 Therapeutics raised US$ 77.5M in Series A and licensed AP306 from Lebang Pharmaceutical, while AstraZeneca announced plans to build a cell therapy center in Shanghai, and CSPC’s SYH2082 received NMPA trial approval. In clinical advancements, Kintor’s pyrilutamide met Phase III endpoints for androgenetic alopecia, Biokin’s bispecific ADC achieved 88% ORR in ES-SCLC, and Sino Biopharma’s TQB3454 showed Phase III success in BTC. Other milestones include Dizal’s ZEGFROVY® Phase III results in NSCLC, Hengrui’s Aidata® approval for HER2+ breast cancer, and Ractigen’s RAG-01 IND approval for NMIBC. These milestones showcase China’s growing strength in biopharma innovation.

Transactions

Novlead Biotechnology Filed for HKEX IPO Under Chapter 18A with 33x Valuation Growth

Key Words: Novlead Biotechnology, IPO, HKEX 18A, nitric oxide, iNOwill, medical device, financing

The News: Novlead Biotechnology has filed for a Chapter 18A IPO on the Hong Kong Exchange. Focused on nitric oxide (NO) therapy, its core product, iNOwill, is the world’s first approved electrochemical NO device, breaking the dominance of imports in China. Its valuation has grown ~33-fold to ~RMB 1.65 billion since 2021.

Key Highlights:

• Core Product – iNOwill:
  • First-in-class electrochemical NO therapy device
  • Approved in China (2022) and received EU CE mark (2025).
  • Entered 80+ hospitals in China with leading domestic market share.
• Financials Details:
  • Generated revenue of RMB 45.5 million (~US$ 6.3 million) in 2024
  • RMB 31.6 million (~US$ 4.4 million) in 9M25.
  • Medical device sales: contributed over 90% of total revenue.
• Capital & Valuation:
  • Raised ~RMB 418 million (~US$ 58 million) since 2021.
  • Valuation reached ~RMB 1.65 billion (~US$ 230 million).

Everest Medicines (1952.HK) Signs LOI to Acquire Haisco’s Singapore Unit

Key Words: Everest Medicines, Haisco Pharmaceutical, Singapore, LOI, acquisition, chronic diseases, cardiovascular, metabolic, APAC

The News: Everest Medicines has signed a non-binding letter of intent (LOI) to acquire 100% equity of Haisco Pharmaceutical (Singapore) Pte. Ltd. from Haisco Pharmaceutical (Asia) Ltd. The acquisition aims to expand Everest’s product pipeline, strengthen its commercial presence in the Asia-Pacific region, and accelerate its commercialisation platform for innovative drugs. Everest will pay a refundable deposit of RMB 200 million (~US$ 27.8 million), which can be applied towards the purchase price.

Key Highlights:

• Haisco (Singapore) focuses on commercializing prescription drugs for chronic and critical diseases, particularly in cardiovascular and metabolic areas, with marketing authorizations, trademarks, and rights for 14 products across multiple APAC markets.
• Expands Everest’s pipeline and aligns with its focus on chronic diseases, including cardiovascular, renal, and metabolic conditions.
• A six-month exclusivity period has been agreed upon for due diligence and negotiation of definitive terms.

Excalipoint Therapeutics Closes US$ 68.7m Seed Round for TCEs

Key Words: Excalipoint Therapeutics, T-cell engager (TCE), seed financing, TOPAbody, tri-specific antibody, solid tumors, autoimmune diseases

The News: Excalipoint Therapeutics, a Shanghai-based biotechnology company specializing in next-generation T-cell engager (TCE) therapies for cancer and autoimmune diseases, announced the closure of an oversubscribed US$ 68.7 million seed financing round. The funding will support the development of the company’s proprietary TCE platforms and a pipeline of six programs targeting solid tumors and immunological diseases.

Key Highlights:

• Funding Details:
  • Initial US$ 41 million seed round in August 2025, co-led by HSG, Apricot Capital, and Yuanbio Venture Capital.
  • US$ 27.7 million extension round co-led by MPCi and Centurium Capital, with participation from LAV, Eisai Innovation Inc., and returning investors.
• Pipeline Programs:
  • Lead candidate EXP011 (CTM012): A tri-specific antibody targeting DLL3, CD3, and 4-1BB, in Phase I/II trials for small cell lung cancer and DLL3-expressing tumors.
  • Additional candidates include EXP012 (CTM013) for gastric and pancreatic cancers and others from the company’s TOPAbody, Immune Shield, and Pro-TCE platforms.
• Technology Platforms:
  • TOPAbody: Tri-specific molecules for enhanced T-cell activation and persistence.
  • Immune Shield: Designed to counteract tumor microenvironment immunosuppression.
  • Pro-TCE: Conditionally activated molecules for improved safety profiles.

R1 Therapeutics Launched with US$ 77.5M Series A and Licensed AP306 from Lebang Pharmaceutical in Global ex-China Deal

Key Words: R1 Therapeutics, Lebang Pharmaceutical, AP306, licensing, Series A, CKD, hyperphosphatemia

The News: R1 Therapeutics raised an oversubscribed US$77.5 million Series A financing, co-led by Abingworth, F-Prime Capital, and DaVita Venture Group, and entered an exclusive licensing agreement with Lebang Pharmaceutical to develop and commercialize AP306 outside Greater China. Proceeds will support the global clinical development of AP306, including a planned Phase IIb study.

Key Highlights:

• Deal Details:
  • Granted exclusive global rights (ex-Greater China) for AP306.
  • Included over US$ 100 million.
• Raised US$ 77.5 million in Series A financing, co-led by Abingworth, F-Prime Capital, and DaVita Venture Group.
• Drug Profile:
  • AP306: first-in-class pan-phosphate transporter inhibitor.
  • Differentiated by blocking active phosphate transport vs. traditional binders.
• Clinical Progress:
  • Significant reduction in serum phosphate in Phase IIa.
  • Phase IIb study planned to initiate in the near term.

AstraZeneca (AZN.L) to Build Cell Therapy Centre in Shanghai

Key Words: AstraZeneca, cell therapy, CAR-T, AZD0120, Shanghai Pilot Free Trade Zone, Zhangjiang Hi-Tech Park, Shanghai-UK Life Sciences Innovation Ecosystem

The News: AstraZeneca (AZ) announced plans to establish a cell therapy manufacturing and supply base in the Shanghai Pilot Free Trade Zone, becoming the first global biopharma company to build end-to-end cell therapy capabilities in China. The facility will focus on autologous CAR-T cell therapies, including the BCMA/CD19 dual-target candidate AZD0120, for Chinese and broader Asian markets.

Key Highlights:

• New Facilities:
  • Commercial cell therapy manufacturing and supply base in the Shanghai Pilot Free Trade Zone.
  • Innovation centre in Zhangjiang Hi-Tech Park for early-stage research, vector development, analytical testing, and clinical manufacturing.
• Strategic Collaboration:
  • Linked to the Shanghai-UK Life Sciences Innovation Ecosystem Cooperation Plan.
  • Involves AZ, the Shanghai Science and Technology Commission, UK academic institutions, and financial partners.

Clinical

CSPC’s (1093.HK) GLP-1/GIP Dual-Biased Agonist SYH2082 Approved for Clinical Trials in China

Key Words: CSPC Pharmaceutical, SYH2082, GLP-1/GIP dual-biased agonist, long-acting injection, obesity, T2DM, clinical trials

The News: CSPC Pharmaceutical announced that its GLP-1/GIP receptor dual-biased agonist long-acting injection (SYH2082) has been approved by China’s National Medical Products Administration (NMPA) for clinical trials. This follows approval by the U.S. FDA in February 2026 for clinical trials in the United States. SYH2082, administered once monthly, is positioned as a leading candidate among long-acting GLP-1/GIP receptor dual-biased agonists in development.

Key Highlights:

• Mechanism of Action:
  • Selectively activates the cAMP pathway while reducing β-arrestin recruitment, minimizing receptor internalization and desensitization.
  • Designed to enhance efficacy, prolong duration of action, and sustain weight loss within monthly dosing intervals.
• Preclinical Data:
  • Demonstrated superior long-term weight loss and maintenance compared to marketed products.
  • Toxicology studies showed good tolerability with no significant adverse effects observed.
• Clinical Potential:
  • Approved for weight management in obese or overweight patients with at least one weight-related comorbidity.
  • Potential to improve glycemic control in adults with type 2 diabetes (T2DM).

Kintor’s (9939.HK) Pyrilutamide Hits Phase III Endpoint, NDA Submission Planned

Key Words: Kintor Pharmaceuticals, Pyrilutamide, KX-826, androgenetic alopecia, AGA, topical antiandrogen, Phase III, NDA

The News: Kintor Pharmaceuticals announced positive topline results from the Phase III trial of pyrilutamide (KX-826) tincture 1.0%, a potential first-in-class topical treatment for male androgenetic alopecia (AGA) in China. The trial met its primary efficacy endpoint, with the 1.0% dose increasing target area hair count by 10.65 hairs/cm² more than placebo.

Key Highlights:

• Clinical Efficacy:
  • Both the 1.0% and 0.5% twice-daily formulations showed statistically significant and clinically meaningful improvements in target area hair count compared to placebo.
  • The 1.0% formulation demonstrated superior efficacy with a 10.65 hairs/cm² increase over placebo.
• Safety:
  • Excellent safety profile with no drug-related serious adverse events reported.
  • Adverse event incidence was comparable to the placebo group.
• MOA: Pyrilutamide is a topical antiandrogen that locally blocks the androgen receptor to treat hair loss.
• Kintor plans to submit a new drug application (NDA) for the 1.0% formulation in China soon, aiming to deliver a groundbreaking non-systemic treatment for male pattern hair loss.

Biokin’s (688506.SS) Bispecific ADC Plus PD-1 Achieves 88% ORR in Front-Line ES-SCLC

Key Words: Biokin Pharmaceutical, BL-B01D1, izalontamab brengitecan, EGFR×HER3, ADC, PD-1, serplulimab, ES-SCLC, Phase II

The News: Biokin Pharmaceutical announced positive Phase II results for its EGFR×HER3 bispecific ADC, izalontamab brengitecan (BL-B01D1), combined with the PD-1 inhibitor serplulimab in first-line extensive-stage small cell lung cancer (ES-SCLC). The data, selected for presentation at the 2026 European Lung Cancer Congress (ELCC), mark the first clinical results of an ADC combined with a PD-1 inhibitor in this setting. The combination achieved an overall response rate (ORR) of 88.3% and a median progression-free survival (mPFS) of 8.2 months.

Key Highlights:

• Clinical Efficacy:
  • ORR of 88.3%.
  • mPFS of 8.2 months in the study population.
• Safety Profile:
  • Common haematologic adverse events included anaemia, thrombocytopoenia, and leukopoenia, all clinically manageable.
  • Low discontinuation rate due to adverse events at 7.3%.
• The 2.5 mg/kg dose (days 1 and 8 of a 21-day cycle) has been selected for further development in China based on the safety and efficacy profile.

Sino Biopharma’s (1177.HK) IDH1 Inhibitor TQB3454 Hits Phase III Milestone in BTC

Key Words: Sino Biopharmaceutical, TQB3454, IDH1 inhibitor, biliary tract cancer, BTC, Phase III, NDA

The News: Sino Biopharmaceutical reported positive interim Phase III results for its IDH1 inhibitor, TQB3454, in advanced biliary tract cancer (BTC) with an IDH1 mutation. The trial met its primary endpoints, showing statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to the control group.

Key Highlights:

• Clinical Efficacy:
  • Statistically significant improvement in PFS and OS.
  • First domestic IDH1 inhibitor in China to achieve successful Phase III results; second globally for BTC.
• Safety Profile:
  • Consistent with known risks; no new safety signals have been identified.
  • Detailed study results to be presented at an international scientific conference later this year.
• Received agreement from China’s Centre for Drug Evaluation (CDE) to submit a new drug application (NDA) for this indication.
• BTC is an aggressive malignancy with poor prognosis and no approved IDH1-targeted therapies in China.

Dizal’s (688192.SS) ZEGFROVY® Achieves Positive Phase III Results in First-Line NSCLC with EGFR exon20ins

Key Words: Dizal, ZEGFROVY, sunvozertinib, WU-KONG28, EGFR exon20ins, NSCLC, Phase III, PFS, chemo-free

The News: Dizal announced positive topline results from its multinational Phase III WU-KONG28 study, evaluating ZEGFROVY® (sunvozertinib) as a first-line treatment for non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (exon20ins). The study met its primary endpoint, showing statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to platinum-based chemotherapy.

Key Highlights:

• Clinical Efficacy:
  • ZEGFROVY significantly improved PFS over platinum-containing chemo doublet.
  • Superior results in all secondary endpoints, including confirmed overall response rate (cORR), duration of response (DOR), and disease control rate (DCR).
• ZEGFROVY was well-tolerated, with a safety profile consistent with previous studies and manageable treatment-emergent adverse events.
• Study Overview:
  • WU-KONG28 is the first and only Phase III study to demonstrate meaningful benefits with an oral, once-daily, chemo-free targeted therapy in this setting.
  • Conducted across 16 countries and regions in Asia, Europe, North America, and South America.
• Dizal plans to engage with regulatory authorities for potential new drug applications (NDAs) based on these results. Detailed data will be presented at an upcoming international scientific congress.

Hengrui’s (600276.SH) Aidata® Approved for Second Indication in HER2+ Breast Cancer

Key Words: Hengrui Pharmaceuticals, Aidata, HER2, ADC, breast cancer, mPFS, HORIZON-Breast01

The News: Hengrui Pharmaceuticals announced that its HER2-targeted ADC, Aidata® (SHR-A1811), has been approved in China for the treatment of HER2-positive breast cancer in patients who have received at least one prior anti-HER2 therapy. This marks its second approved indication.

Key Highlights:

• In the Phase III HORIZON-Breast01 study, Aidata® achieved a median progression-free survival (mPFS) of 30.6 months and an objective response rate (ORR) of 81.7%, the first HER2 ADC in China’s second-line setting to exceed 30 months mPFS.
• Demonstrated favorable tolerability with a low rate of interstitial lung disease (2.8%) and treatment discontinuation (<5%).
• About Aidata®:
  • Aidata® is an innovative HER2-targeted antibody-drug conjugate (ADC) developed by Hengrui Pharmaceuticals.
  • It features a cleavable tetrapeptide linker and optimized drug-to-antibody ratio (DAR) of 6:1, offering enhanced efficacy and safety by reducing premature toxin release.
  • In May 2025, Aidata® was approved in China for HER2-mutated non-small cell lung cancer (NSCLC) in patients who had received prior systemic therapy, making it the first domestically developed HER2-targeted ADC approved for NSCLC in China.

Ractigen Therapeutics Receives China NMPA IND Approval for Phase II Clinical Trial of RAG-01 in NMIBC

Key Words: Ractigen Therapeutics, RAG-01, saRNA, NMIBC, IND Approval, RNAa

The News: Ractigen Therapeutics, a clinical-stage biotechnology company pioneering small activating RNA (saRNA) therapeutics, announced that China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved its Investigational New Drug (IND) application to initiate a Phase II clinical trial of RAG-01 for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). This approval marks a significant milestone, making RAG-01 the second saRNA therapeutic to receive IND clearance in China, both of which were developed by Ractigen.

• Key Highlights:
• RAG-01 is a first-in-class saRNA therapeutic designed to activate the tumor suppressor gene p21 via RNA activation (RNAa). Delivered using Ractigen’s proprietary LiCO™ technology, it has demonstrated safety, target engagement, and efficacy in Phase I trials in Australia. In 2024, RAG-01 received IND clearance and Fast Track designation from the U.S. FDA.
• About the Trial:
  • The Phase II study will be a randomized, controlled, multi-center trial evaluating RAG-01 as monotherapy and in combination with chemotherapy in intermediate- and high-risk NMIBC patients.
  • The trial builds upon promising Phase I data from Australia, where RAG-01 demonstrated favorable safety, clear p21 target engagement, and encouraging complete response (CR) signals.
• Non-Muscle Invasive Bladder Cancer (NMIBC) is a bladder-lining malignancy often treated with TURBT and intravesical BCG or chemotherapy. High recurrence and treatment failure rates underscore the need for new therapies like RAG-01.
• Ractigen Therapeutics is a clinical-stage biopharmaceutical company focused on saRNA-based therapies using its proprietary RNAa technology. With advanced delivery platforms like SCAD™, LiCO™, and GLORY™, it is developing a pipeline targeting oncology, neurological, and genetic disorders.

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.

DISCLAIMER

This document is prepared by Selesta Partners Limited (“Selesta”) for information purposes only.  Neither Selesta nor the Directors of the company accept any responsibility whatsoever for the accuracy or completeness of the information provided by third parties contained in this document. It should not be copied or distributed to third parties without the written consent of Selesta.

The views expressed (if any) are the views of Selesta only and are subject to change based on market and other conditions. The information provided does not constitute investment advice and it should not be relied on as such. All material has been obtained from sources believed to be reliable at the date of presentation, but its accuracy is not guaranteed. This material contains certain statements that may be deemed forward-looking statements. Please note that any such statements are not guarantees of any future performance and actual results or developments may differ materially from those projected.

The information contained herein does not constitute an offer to sell or an invitation to buy any securities in any jurisdiction in which such distribution or offer is not authorized to any person. No part of this document, or any information contained herein, may be distributed, reproduced, taken or transmitted into jurisdiction or territories/ possession in which such activities are not permitted. Any failure to comply with the restrictions may constitute a violation of the relevant laws.

This document does not constitute a prospectus, an offer or an invitation to subscribe to any securities, or a recommendation in relation to any securities.

Investors should note investment involves risk and past performance is not indicative of future results.

© 2026 Selesta