This week’s biotech updates feature Braveheart Bio’s US$ 382.5M Nasdaq IPO backed by a US$ 1.09B Hengrui deal (myosin inhibitor), Vogenx’s US$ 75M filing for SGLT1 inhibitor, Mabworks’ third IPO attempt after NMOSD/PMN approvals, and Biokin’s renewed Hong Kong H-share listing application powered by ADC and ARC tech advancements.

Transactions & BD (In/Out Licensing)

Braveheart Bio (BRVE.O) Prices US$ 382.5 Million Nasdaq IPO with US$ 1.09 Billion Hengrui (600276.SH) Licensing Deal Backing Its HCM Drug

Key Words: Braveheart Bio, Hengrui Medicine, BHB-1893, hypertrophic cardiomyopathy, IPO, Nasdaq, licensing, myosin inhibitor

• The News: On August 6, 2026, Braveheart Bio, Inc. priced an upsized US$ 382.5 million IPO and began trading on Nasdaq under the ticker BRVE, raising funds to support global Phase III development of BHB-1893, an oral selective cardiac myosin inhibitor for hypertrophic cardiomyopathy (HCM). The company licensed global rights outside Greater China from Hengrui Medicine in September 2025, with a total potential deal value of up to US$ 1.09 billion.
• Key Highlights:
• Deal Details:
  • Total Deal Value: Up to US$ 1.09 billion, including a US$ 65 million upfront payment split equally between cash and non-voting Series A preferred stock.
  • Milestones: Additional US$ 10 million near-term milestone upon technology transfer completion, plus up to US$ 1.01 billion in clinical, regulatory, and commercial milestones.
• Product Profile – BHB-1893:
  • BHB-1893: An oral selective small-molecule cardiac myosin inhibitor discovered and developed by Hengrui through Phase II trials.
  • Mechanism: Targets myocardial hypercontractility to improve diastolic function and ventricular filling in HCM patients.
  • Indication Focus: Covers both obstructive and non-obstructive hypertrophic cardiomyopathy.
  • Clinical Data: Suggests BHB-1893 may minimize left ventricular ejection fraction reduction, a known limitation of approved myosin inhibitors.

Vogenx Files for US$ 75 Million IPO to Advance SGLT1 Inhibitor Mizagliflozin

Key Words: Vogenx, IPO, SGLT1, mizagliflozin, post-bariatric hypoglycemia, gastroparesis, Kissei Pharmaceutical

• The News: Vogenx, a clinical-stage biotech based in Raleigh, North Carolina, filed an S-1/A with the SEC on July 29, 2026, planning to offer 6.3 million shares at US$ 11 to US$ 13 each, targeting US$ 75 million in gross proceeds. The company, which operates with only five full-time employees and outsources all clinical and CRO work, expects a fully diluted valuation of US$ 173 million at the midpoint.
• Key Highlights:
• Deal Details:
  • IPO Size: 6.3 million shares at US$ 11–13 per share, targeting US$ 75 million gross proceeds.
  • Valuation: US$ 173 million fully diluted at midpoint.
  • Filing: Revised S-1/A submitted July 29, 2026.
• Product Profile – Mizagliflozin:
  • Mizagliflozin: An oral SGLT1 inhibitor licensed from Kissei Pharmaceutical and developed by Vogenx for gastrointestinal and metabolic diseases.
  • Mechanism: Blocks intestinal SGLT1-mediated glucose absorption, reducing postprandial glucose spikes and enhancing gut hormone signaling, including GLP-1 pathways.
  • Indication Focus: Post-bariatric hypoglycemia and gastroparesis.
  • Development Stage: Clinical-stage asset advancing in GI metabolic indications.
• Vogenx: A clinical-stage biopharma developing therapies for metabolic dysfunction, with a lean five-person team and fully outsourced operations.

Mabworks Files Third IPO Attempt on Beijing Stock Exchange After Securing First-in-World Kidney Disease Antibody Approval

Key Words: MIL62, primary membranous nephropathy, NMOSD, CD20 antibody, IPO, Beijing Stock Exchange

• The News: Mabworks submitted a prospectus to the Beijing Stock Exchange in August 2026, marking its third attempt at a public listing after prior failures on the STAR Market and Hong Kong Stock Exchange. The filing follows the 2026 approvals of MIL62 for neuromyelitis optica spectrum disorder (NMOSD) and primary membranous nephropathy (PMN), the latter being the world’s first approved therapy for PMN and ahead of Roche’s pipeline.
• Key Highlights:
• Deal Details:
  • IPO Status: Third listing attempt under BSE Rule 4, requiring expected market value of at least RMB 1.5 billion and cumulative R&D investment of RMB 50 million over the past two years.
  • Financing History: Company remains unprofitable with no scaled product sales as of end-2025, spending nearly RMB 200 million annually on R&D.
  • Licensing Income: 2025 revenue reached RMB 128 million, driven by a licensing fee, up from RMB 13.01 million in 2024.
  • Out-Licensing: Granted overseas rights for IgA nephropathy drug MIL116 to Nasdaq-listed Climb Bio for US$ 9 million upfront and up to US$ 880 million in milestones; also licensed Asia-Pacific rights for MIL62 to Everest Medicines (1952.HK).
• Product Profile – MIL62:
  • MIL62: A novel anti-CD20 monoclonal antibody with enhanced Fc glycosylation engineering for stronger B-cell killing, approved in China for NMOSD and PMN.
  • Mechanism: Targets CD20 on B lymphocytes, improving antibody-dependent cellular cytotoxicity versus earlier generations.
  • Indication Focus: NMOSD (China’s first domestic drug for the rare disease, reducing relapse risk by 93.1% in Phase 3) and PMN (49.4% complete remission at 76 weeks vs 3.9% for control).
  • Development Stage: Two additional Phase 3 trials ongoing for follicular lymphoma (NDA expected 2026) and systemic lupus erythematosus (NDA expected 2027).
• Mabworks: A Beijing-based biotech founded in 2003, led by former Genentech engineer Li Feng, developing third-generation antibody therapies for autoimmune and oncology indications with no commercial-stage revenue until 2026.

Biokin Pharmaceutical (688506.SH) Refiles for Hong Kong H-Share Listing After Withdrawing 2025 Offering

Key Words: Biokin, H-share, Hong Kong listing, ADC, ARC, TCE, iza-bren, commercialization

• The News: Biokin Pharmaceutical submitted a fresh H-share listing application to the Hong Kong Stock Exchange on August 6, after delaying its 2025 global offering and refunding subscription proceeds. The company, valued at RMB 124.6 billion on the STAR Market, is advancing 15 clinical-stage candidates with five in overseas development, anchored by its approved oncology drug iza-bren.
• Key Highlights:
• Deal Details:
  • Transaction Type: H-share issuance and listing application filed with Hong Kong Stock Exchange.
  • Company Valuation: RMB 124.6 billion market cap on Shanghai STAR Market.
  • Shareholding: Founder Zhu Yi holds 72.22%; OrbiMed holds 5.91%.
• Platform Profile – Biokin R&D System:
  • Biokin operates dual R&D centers in Chengdu and Seattle, with three proprietary platforms: ADC, antibody-radionuclide conjugates (ARC), and multispecific T-cell engagers (TCE).
  • Pipeline includes 15 clinical-stage candidates, five in development outside China.
  • Strategy combines large-scale killing plus precision targetingacross ADC, ARC, and TCE to convert malignancies into chronic, manageable diseases.
• Product Profile – Iza-bren:
  • Iza-bren: A first-in-class EGFR×HER3 bispecific antibody-drug conjugate (ADC), designed to simultaneously target EGFR and HER3 expressing tumor cells for precision oncology applications.
  • Mechanism: Dual targeting of EGFR and HER3 enables selective tumor cell binding and delivery of cytotoxic payloads, aiming to enhance anti-tumor activity across tumors with heterogeneous receptor expression.
  • Indication Focus: Multiple solid tumors, including NSCLC, breast cancer, esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, and head and neck cancer.
  • Development Stage: Late-stage clinical development ongoing, with NDA submissions/market approval progress in China for selected indications; Phase I–III studies ongoing across solid tumors.

Alphamab Oncology (9966.HK) Licenses First-in-Class TROP2/HER3 ADC to Pathos AI for Up to US$ 2.09 Billion

Key Words: Alphamab Oncology, Pathos AI, JSKN016, TROP2/HER3, ADC, license, first-in-class

• The News: Alphamab Oncology’s wholly-owned subsidiary Jiangsu Alphamab has granted Pathos AI an exclusive license to develop, manufacture, and commercialize JSKN016, a first-in-class TROP2/HER3 bispecific antibody-drug conjugate, outside mainland China, Hong Kong, Macau, and Taiwan. The deal includes a non-refundable upfront payment of US$ 125 million, potential milestone payments totaling up to US$ 2.09 billion.
• Key Highlights:
• Deal Details:
  • Total Deal Value: Up to US$ 2.09 billion in upfront and milestone payments.
  • Upfront Payment: US$ 125 million non-refundable.
  • Alphamab receives a warrant to subscribe for Pathos AI preferred shares at a total price of US$ 62.5 million, exercisable at Alphamab’s discretion.
• Product Profile – JSKN016:
  • JSKN016: A first-in-class TROP2/HER3 bispecific antibody-drug conjugate developed using Alphamab’s single-domain antibody, bispecific antibody, and glycan-site-specific conjugation platforms.
  • Mechanism: Binds tumor cell surface receptors to block oncogenic signaling pathways and releases a topoisomerase I inhibitor at the tumor site for targeted killing.
  • Indication Focus: Multiple solid tumors, including lung cancer, breast cancer, and triple-negative breast cancer.
  • Development Stage: Phase II studies ongoing for monotherapy and combination regimens; Phase III study underway for triple-negative breast cancer.

CSPC Pharmaceutical Group (1093.HK) and AstraZeneca (AZN.N) Form Joint Venture for Biologics Manufacturing in China

Key Words: joint venture, biologics manufacturing, CSPC, AstraZeneca, drug substance, GMP, supply chain

• The News: CSPC Pharmaceutical Group and AstraZeneca signed a joint venture contract to build a next-generation biologics manufacturing base in Shijiazhuang, China, with CSPC holding 51% and AstraZeneca 49% equity. The venture will initially produce and supply agreed biologic drug substance (DS) for global markets, pending customary closing conditions including regulatory approvals.
• Key Highlights:
• Deal Details:
  • Equity Structure: CSPC 51%, AstraZeneca 49%, with joint management of construction and daily operations.
  • Initial Scope: Production and supply of biologic drug substance (DS) for global markets.
• Product Profile – Joint Venture:
  • The venture combines CSPC’s AI-driven GMP systems, construction, and operational expertise with AstraZeneca’s global quality standards and supply chain management.
  • Marks CSPC’s internationalization extending from product and technology export to production system and supply chain capability export.

WuXi Biologics (2269.HK) to Acquire Transcenta (6628.HK) CDMO Assets for RMB 190 Million

Key Words: WuXi Biologics, Transcenta, CDMO, asset acquisition

• The News: Transcenta Holding Limited has entered into an asset purchase agreement with WuXi Biologics to sell its Hangzhou CDMO assets for RMB 190 million (approximately US$ 26.2 million). The deal enables Transcenta to exit physical manufacturing and focus on advancing its drug pipeline and proprietary bioprocessing technology licensing.
• Key Highlights:
• Deal Details:
  • Total Deal Value: RMB 190 million, payable in four tranches (50% upfront, 15% at Phase I completion, 20% at Phase II completion, and 15% final payment within six months after Phase II completion).
  • Asset Breakdown: Includes land use rights, building ownership, facilities, equipment, business contracts, and designated employees. Intellectual property, such as the HiCB continuous bioprocessing platform and ExcelPro CHO cell culture media, is excluded.
  • Transaction Background: The assets generated revenue of RMB 6.38 million but incurred a loss of RMB 58.25 million in 2025. The consideration reflects a modest discount to their appraised value of RMB 198.8 million.

Clinical

Hengrui Medicine (600276.SH) Reports Positive Phase III Head-to-Head Results for GLP-1/GIP Dual Agonist Ribupatide Against Semaglutide

Key Words: GLP-1, GIP, ribupatide, semaglutide, type 2 diabetes, Phase III, Hengrui Medicine

• The News: Hengrui Medicine announced positive topline results from the Phase III HRS9531-303 trial, where ribupatide injection 4mg and 2mg met the primary endpoint of non-inferiority in HbA1c change from baseline versus semaglutide injection 1mg in adults with type 2 diabetes. Based on these results, Hengrui plans to file a new drug application in China for ribupatide injection for glycemic control in adults with type 2 diabetes.
• Key Highlights:
• Clinical Data:
  • Study Design: multicenter, randomized, open-label, active-controlled Phase III trial (n=884) comparing ribupatide 4mg and 2mg versus semaglutide 1mg over 36 weeks in patients inadequately controlled on metformin alone or with SGLT2 inhibitors.
  • Primary Endpoint: HbA1c mean reductions of 2.78% (4mg) and 2.34% (2mg) versus 2.29% for semaglutide, both meeting non-inferiority.
  • Key Secondary Endpoint: 4mg dose showed HbA1c difference of -0.49% versus semaglutide, with superiority test one-sided p<0.0001.
  • Glycemic Control: HbA1c≤6.5% achievement rates of 85.0% (4mg) and 69.0% (2mg) v 64.3% for semaglutide; composite HbA1c<7.0% plus weight loss≥5% rates of 66.2% and 43.2% vs. 42.8%.
  • Safety Profile: generally well tolerated, with mostly mild-to-moderate gastrointestinal events consistent with prior data and other GLP-1 class drugs.
• Product Profile – Ribupatide:
  • Ribupatide: A dual agonist of glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR), developed as a once-weekly subcutaneous injection and once-daily oral tablet.
  • Mechanism: Dual GLP-1R and GIPR agonism for glycemic control and weight management.
  • Indication Focus: Type 2 diabetes and chronic weight management.
  • Development Stage: Injection filed in China in September 2025 for long-term weight management; oral tablet initiated first Phase III trial in July; NDA planned for type 2 diabetes.

Transthera’s (2617.HK) First Innovative Drug Wins Market Approval for Advanced Cholangiocarcinoma

Key Words: Transthera, tinengotinib, cholangiocarcinoma, FGFR inhibitor, NMPA approval, ESMO data

• The News: China’s NMPA approved Transthera’s tinengotinib tablets for adult patients with advanced, metastatic, or unresectable cholangiocarcinoma who have received at least one prior systemic therapy and an FGFR inhibitor. This marks Transthera’s first innovative drug to reach market, with pooled ESMO 2025 data showing a median PFS of 7.26 months and median OS of 15.93 months in 55 FGFR2-variant patients.
• Key Highlights:
• Clinical Data:
  • Study Design: Pooled analysis of 110 advanced cholangiocarcinoma patients as of October 16, 2024; 59.1% had received ≥3 prior lines, over 46% had prior FGFR inhibitor therapy.
  • Efficacy: In 55 FGFR2-variant patients, mPFS 7.26 months and mOS 15.93 months; in 35 patients with prior systemic and FGFR inhibitor treatment, mPFS 6.01 months and mOS 17.05 months.
  • Safety Profile: Noteworthy for a next-generation inhibitor designed to overcome acquired FGFR2 resistance mutations.
• Product Profile – Tinengotinib:
  • Tinengotinib: A self-developed multi-target small-molecule kinase inhibitor that targets tumor cells and improves the tumor microenvironment.
  • Mechanism: Higher affinity for FGFR compared with first-generation FGFR inhibitors, addressing resistance driven by acquired FGFR2 mutations.
  • Indication Focus: Advanced, metastatic, or unresectable cholangiocarcinoma.
  • Development Stage: Approved by NMPA; first innovative drug from Transthera to receive market authorization.

Sunshine Guojian (688336.SH) Files IND Application for First-in-Class IL-23/TL1A Bispecific Antibody SSGJ-718

Key Words: Sunshine Guojian, SSGJ-718, IL-23/TL1A bispecific antibody, IND, inflammatory diseases, 3SBio Pharmaceutical

• The News: Sunshine Guojian, a subsidiary of 3SBio, submitted an Investigational New Drug application to China’s Center for Drug Evaluation for SSGJ-718, a first-in-class IL-23/TL1A bispecific antibody. If approved, SSGJ-718 would become the first IL-23/TL1A bispecific antibody to enter clinical development globally.
• Key Highlights:
• Regulatory Milestone: SSGJ-718 submitted an IND application to China’s CDE, becoming the first IL-23/TL1A bispecific antibody candidate globally to advance toward clinical development.
• Product Profile – SSGJ-718:
  • SSGJ-718: A first-in-class IL-23/TL1A bispecific antibody developed by Sunshine Guojian, designed to simultaneously neutralize IL-23 and TL1A signaling pathways.
  • Mechanism: Dual blockade of IL-23, a key driver of Th17-mediated inflammatory responses, and TL1A, a cytokine involved in intestinal inflammation and immune regulation.
  • Indication Focus: Primarily focused on immune-mediated inflammatory diseases, including inflammatory bowel disease (IBD) such as Crohn’s disease and ulcerative colitis, where both IL-23 and TL1A pathways are implicated.
  • Development Stage: IND submitted in China; positioned as the first global IL-23/TL1A bispecific antibody candidate entering clinical development.

Luzhu Biotech (2480.HK) Reports Positive Phase III Results for Shingles Vaccine LZ901

Key Words: Luzhu Biotech, LZ901, shingles vaccine, Phase III, efficacy

• The News: On August 7, 2026, Luzhu Biotech announced that the Phase III clinical trial results for its core product, LZ901, were published in Nature Communications. The trial evaluated the efficacy and safety of LZ901 in adults aged 40 years and older for the prevention of shingles.
• Key Highlights:
• Study Design:
  • Multi-center, randomized, double-blind, placebo-controlled trial involving 26,039 participants.
  • A total of 25,577 participants completed two doses of LZ901 or placebo, administered 30 days apart.
• Efficacy Results:
  • Overall Vaccine Efficacy: 91.6% (95% CI: 86.3%–95.3%) within one-year post-vaccination.
  • Lab-Confirmed Cases: 92.1% (95% CI: 86.7%–95.7%) efficacy against lab-confirmed shingles cases.
  • Complication Prevention: 95.9% (95% CI: 63.9%–99.9%) efficacy against postherpetic neuralgia (PHN) and 92.6% (95% CI: 87.2%–96.1%) efficacy against severe acute pain related to shingles.
• Safety and Tolerability:
  • Adverse Events: Reported in 16.4% of the LZ901 group (vs. 9.0% in the placebo group; p<0.001) within 30 days post-vaccination.
  • Solicited Reactions (within 7 days):
  • Injection-site reactions: 11.6% in the LZ901 group vs. 3.7% in the placebo group (p<0.001).
  • Systemic adverse events: 5.2% in the LZ901 group vs. 4.3% in the placebo group (p<0.001).
  • Grade 3 Adverse Events: No significant difference observed (LZ901: 0.4%, placebo: 0.3%; p=0.672).

Hengrui’s (1276.HK; 600276.SS) HER2 ADC Trastuzumab Rezetecan Receives NMPA Approval for New Indication

Key Words: Hengrui, Trastuzumab Rezetecan, HER2 ADC, colorectal cancer, NMPA approval, new indication

• The News: On August 6, 2026, the NMPA approved a new indication for Hengrui’s HER2 ADC, Trastuzumab Rezetecan, for the treatment of adult patients with HER2-positive colorectal cancer who have failed prior treatments with oxaliplatin, fluoropyrimidine, and irinotecan (Application Number: CXSS2600018).
• Key Highlights:
• Approval History: this marks the third approved indication for Trastuzumab Rezetecan in China.
  • May 2025: Approved for HER2-mutant, locally advanced or metastatic NSCLC.
  • March 2026: Approved for HER2-positive, locally advanced or metastatic breast cancer following prior HER2 therapy.
• Key Clinical Trial (HORIZON-CRC01):
  • Phase III, multicenter, open-label, randomized controlled trial.
  • Enrolled 130 patients with HER2-positive (IHC 3+ or IHC 2+/ISH+), RAS/RAF wild-type, advanced colorectal cancer that had failed prior standard treatments.
  • Primary Endpoint: Progression-Free Survival (PFS), assessed by an Independent Review Committee (IRC).
• Results:
  • Median PFS: 5.5 months for the Trastuzumab Rezetecan group vs. 2.8 months for the SOC group (HR = 0.33, P < 0.0001).
  • ORR: 40.7% for the Trastuzumab Rezetecan group vs. 4.5% for the SOC group (P < 0.0001).
  • Safety: Well-tolerated with no new safety signals observed; no patients discontinued treatment due to TRAEs.

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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