This week, biotech highlights include ImmVira’s RMB 3.5B Hong Kong IPO filing (MVR-T3011, bladder cancer), Trinomab’s RMB 999M STAR Market debut (tetanus mAb), and Qilu-TYK’s RMB 2.76B EGFR-TKI partnership (NSCLC).

Transactions & BD (In/Out Licensing)

ImmVira Files for Hong Kong IPO at a Valuation of RMB 3.5 Billion

Key Words: ImmVira, IPO, Hong Kong, oncolytic virus, MVR-T3011, bladder cancer, engineering exosomes, Merz

• The News: ImmVira, a Shenzhen-based biotech developing oncolytic viruses and engineered exosomes, submitted a Hong Kong IPO prospectus. The company has raised over RMB 1 billion across seven funding rounds, with a post-money valuation of US$ 485 million in its last round.
• Key Highlights:
• Deal Details:
  • IPO Status: ImmVira filed a Hong Kong IPO prospectus, seeking to list as the “first oncolytic virus stock” in China.
  • Financing History: raised over RMB 1 billion across seven rounds; last round in January 2024 raised US$ 14 million at a US$ 485 million post-money valuation.
  • Cash Position: as of May 31, 2026, cash and equivalents were only RMB 17.04 million, with a monthly burn rate of approximately RMB 9.9 million.
• Product Profile – MVR-T3011:
  • MVR-T3011: a next-generation oncolytic herpes simplex virus type 1 (HSV-1) designed with a novel backbone that deletes approximately 10% of the viral genome and encodes anti-PD-1 antibody and IL-12.
  • Mechanism: engineered to selectively infect and lyse tumor cells while sparing normal tissue; replication capacity is 1,000-fold higher than T-VEC, the only FDA-approved oncolytic virus.
  • Indication Focus: bladder cancer; also, the first oncolytic virus globally to receive clinical approval for intravenous administration in both the US and China.
  • Clinical Data: in a Phase I/II bladder cancer study, high-dose group (1×10¹⁰ PFU) achieved 100% complete response rate in carcinoma in situ patients at all time points; low-dose group showed 74% 12-month recurrence-free survival, versus 44% for approved ADSTILADRIN.
• ImmVira: a clinical-stage biotechnology company focused on oncolytic virus therapies and engineered exosome platforms, headquartered in Shenzhen, China.

Trinomab Pharm (688806.SH) Debuts on the STAR Market, Rewriting a Century of Passive Immunity History in China

Key Words: IPO, STAR Market, Trinomab Pharm, passive immunity, tetanus, monoclonal antibody, RSV, HitmAb platform

• The News: Trinomab Pharm listed on the STAR Market on July 21, 2026, at an issue price of RMB 14.46 per share, raising RMB 999 million. The IPO marks the first time a Chinese-originated innovative antibody drug for tetanus prophylaxis has entered the capital market, replacing century-old equine serum and plasma-derived products.
• Key Highlights:
• Deal Details:
  • Total IPO proceeds: RMB 999 million, allocated to new drug R&D, antibody production base expansion, and working capital.
  • B round financing led by Yifeng Capital in 2023, supporting nationwide hospital access for the lead product.
  • First company to be accepted and successfully listed under the STAR Market’s revived fifth-set listing standards for pre-profit biotechs.
• Product Profile – Staidetumab (Newtituo):
  • Staidetumab (Newtituo): a first-in-class recombinant anti-tetanus toxin monoclonal antibody approved in China in February 2025 for adult tetanus emergency prophylaxis.
  • Mechanism: gene-recombinant, fully human monoclonal antibody targeting tetanus toxin, eliminating need for skin testing and animal/human plasma sourcing.
  • Indication Focus: tetanus prophylaxis; rapid onset within 12 hours, protection duration over 90 days.
  • Regulatory Status: included in China’s National Reimbursement Drug List (NRDL) effective January 1, 2026; post-launch coverage across 31 provinces, 1,200+ hospital terminals, and 150+ distributors.
• Trinomab Pharm: A China-based biopharmaceutical company developing fully human monoclonal antibody therapies, with a focus on blood-product replacement therapies and innovative biologics for infectious and immune-related diseases.

Qilu Pharmaceutical and TYK Medicines (2410.HK) Reach RMB 2.76 Billion Strategic Collaboration for EGFR-TKI TY-9591

Key Words: TY-9591, EGFR-TKI, NSCLC, Qilu Pharmaceutical, TYK Medicines, collaboration, commercialization, equity investment, milestone payments

• The News: TYK Medicines entered a three-part strategic collaboration with Qilu Pharmaceutical covering TY-9591 (edotinib mesylate, brand name Kadasha), including a technology license, supply and commercialization agreement, and an H-share subscription. The deal provides TYK with RMB 700 million in upfront payments and up to RMB 2.06 billion in milestones.
• Key Highlights:
• Deal Details:
  • Total deal value: up to RMB 2.76 billion, comprising RMB 300 million cash upfront, RMB 400 million equivalent H-share subscription, and up to RMB06 billion in regulatory and indication-expansion milestones.
  • Qilu’s wholly owned investment platform Anchor International Limited will subscribe to 63.22 million new H-shares at HK$ 7.30 per share, a 13.3% discount to the last closing price, for total consideration of approximately HK$ 462 million.
  • Post-transaction, Qilu will hold 14.26% of TYK’s enlarged share capital, with a six-month lock-up period.
  • Net proceeds from the subscription will be allocated 50% to TY-0540 Phase II/III trial in platinum-resistant ovarian cancer, 40% to TY-0540 plus fulvestrant Phase II/III trial in CDK4/6-resistant breast cancer, and 10% for working capital.
• Product Profile – TY-9591:
  • TY-9591: a next-generation, highly selective, irreversible EGFR-TKI designed with optimized pharmacokinetics to reduce toxic metabolite generation.
  • Mechanism: selectively inhibits mutant EGFR signaling, including activating mutations and T790M resistance mutations, blocking downstream pathways involved in tumor growth.
  • Indication Focus: EGFR-mutant non-small cell lung cancer, including brain metastases and L858R mutation subtypes.
  • Development Stage: NDA accepted by CDE in early 2026 with priority review; registration trial for combination with chemotherapy initiated.

Axiom Biosciences Plans Hong Kong IPO in 2027 as First US Biotech to Choose HKEX as Primary Listing Venue

Key Words: Axiom Biosciences, Hong Kong IPO, HKEX, cell therapy, mesenchymal stem cell, neonatal neurology, Partners Investment

• The News: Axiom Biosciences, a San Diego-based clinical-stage biotech, announced plans for a 2027 Hong Kong IPO under HKEX Chapter 18A, with a subsequent Nasdaq listing. If completed, it would be the first US biotech to use Hong Kong as its primary listing venue.
• Key Highlights:
• Deal Details:
  • IPO Status: planned 2027 Hong Kong IPO under HKEX Chapter 18A, followed by Nasdaq listing.
  • Financing History: US$ 11.7 million Series A in 2023 led by Partners Investment (Seoul), with participation from Asian and US investors.
  • Rights Granted / Deal Structure: HKEX 18A eligibility requires at least one Phase I-completed core drug; Axiom meets this with its MSC therapy co-developed with Korea’s Medinno.
• Product Profile – MSC Therapy:
  • MSC Therapy: an allogeneic mesenchymal stem cell therapy for neonatal intraventricular hemorrhage or hypoxic-ischemic encephalopathy.
  • Mechanism: effected through multiple mechanisms, including paracrine secretion of growth factors, anti-inflammatory cytokines, and extracellular vesicles, which promote tissue repair, regulate immune responses, and reduce neuroinflammation.
  • Indication Focus: initially focused on neonatal neurological disorders, including conditions associated with brain injury and developmental impairment.
  • Clinical Data: nine treated infants showed zero mortality at two-year follow-up, versus a 46% first-year mortality rate in untreated severe cases.
  • Development Stage: clinical-stage, Phase I completed.
• Axiom Biosciences: a clinical-stage US biotech founded in 2018, pivoted from regenerative medicine to cell therapy, targeted biologics, and AI-assisted drug design, with all pipeline assets in clinical development.

Byterna Raises Pre-Series A for In Vivo circmRNA CAR-T, Cancer Vaccines

Key Words: Byterna, Pre-Series A, circmRNA, in vivo CAR-T, cancer vaccine, Insilico Medicine, BR101

• The News: China-based Byterna closed a multimillion RMB Pre-Series A round with continued support from EFung Capital and new strategic participation from Insilico Medicine. Proceeds will accelerate clinical filing for BR101, a first-in-class dual-target circular mRNA in vivo CAR-T candidate in IIT and fund an AI-driven personalised circmRNA tumour vaccine pipeline.
• Key Highlights:
• Deal Details:
  • Total Deal Value: multimillion RMB Pre-A round.
  • Investors: EFung Capital (existing) and Insilico Medicine (new strategic).
  • Use of Proceeds: clinical filing for BR101, AI-driven personalised circmRNA tumour vaccine pipeline, and co-development of an AI-Native R&D engine with Insilico.
• Product Profile – BR101:
  • BR101: A first-in-class dual-target circmRNA-based in vivo CAR-T therapy designed to generate CAR-T cells directly within patients.
  • Mechanism: uses circular mRNA to transiently engineer patient T cells in vivo, enabling dual-antigen tumor targeting while avoiding permanent genomic modification and reducing manufacturing complexity.
  • Indication Focus: hematological malignancies and potentially solid tumors with unmet needs for accessible and durable CAR-T therapies.
  • Development Stage: clinical-stage program in IIT evaluation, with regulatory filing preparation underway.
• Byterna: Founded June 2023, specialises in next-generation RNA therapeutics combining circmRNA translational stability with AI-guided antigen prediction and sequence optimisation.

Clinical

Universal CAR-T Challenges Solid Tumors as Maximum Biotech’s MT027 Preliminary Human Data to Debut at World Conference on Lung Cancer

Key Words: B7H3, CAR-T, universal, brain metastasis, WCLC, MT027, Maximum Biotech

• The News: Maximum Biotech announced that preliminary human data for MT027, a universal B7H3-targeted allogeneic CAR-T candidate, will be presented at the 2026 World Conference on Lung Cancer (WCLC) in Seoul, South Korea, from September 12–15. The data, focused on brain metastases, marks the second international academic conference appearance for MT027.
• Key Highlights:
• Clinical Data:
  • Study Design: preliminary human data for MT027 in B7H3-positive brain metastases, using local intracavitary delivery.
  • Safety: local delivery strategy aims to minimize systemic exposure in the CNS.
• Product Profile – MT027:
  • MT027: a universal allogeneic CAR-T candidate targeting B7H3, delivered via local intracavitary injection for CNS tumors and solid tumor metastases.
  • Mechanism: targets B7-H3 expressed on tumor cells to activate CAR-T-mediated immune killing, while leveraging an off-the-shelf allogeneic platform.
  • Indication Focus: solid tumors with high unmet need, particularly B7-H3-positive cancers and brain metastases.
  • Development Stage: Phase II preparation ongoing in the US; IIT data for brain metastases accepted at WCLC.
• Maximum Biotech: a China-based biotech developing universal allogeneic CAR-T therapies with a local delivery platform for solid tumors, led by founder Dr. Shang Xiaoyun.

DualityBio’s (9606.HK) B7-H3 ADC DB-1311/BNT324 Granted Breakthrough Therapy Designation in China for mCRPC

Key Words: DualityBio, B7-H3, ADC, DB-1311, BNT324, breakthrough therapy, mCRPC, BioNTech, I/II trial, rPFS, OS

• The News: DualityBio’s B7-H3 ADC DB-1311/BNT324 was granted breakthrough therapy designation by China’s CDE for metastatic castration-resistant prostate cancer (mCRPC) after prior androgen receptor pathway inhibitor and taxane therapy.
• Key Highlights:
• Clinical Data:
  • Study Design: global Phase I/II, 146 mCRPC patients, DB-1311/BNT324 at 6 or 9 mg/kg Q3W.
  • Efficacy: median rPFS 11.3 months, median OS 22.5 months in 129 evaluable patients; in 84 patients without prior ¹⁷⁷Lu-PSMA-617, median rPFS 13.6 months; in 45 with prior ¹⁷⁷Lu-PSMA-617, median rPFS 11.3 month
  • Safety: most common TRAEs were grade 1–2 nausea and hematologic events; at 6 mg/kg Q3W (n=110), 20.0% grade 3 TRAEs, 5.5% TRAEs leading to discontinuation.
• Product Profile – DB-1311/BNT324:
  • DB-1311/BNT324: a next-generation B7-H3-targeted antibody-drug conjugate (ADC).
  • Mechanism: targets B7-H3-expressing tumor cells and delivers a TopoI inhibitor payload through ADC-mediated internalization, causing DNA damage and tumor cell death.
  • Indication Focus: initially targeting mCRPC after AR pathway inhibitor and taxane failure, with potential expansion across B7-H3-positive solid tumors.
  • Development Stage: Phase I/II clinical-stage ADC; received China CDE Breakthrough Therapy Designation for mCRPC.

Innovent Biologics (1801.HK) Initiates Phase III Trial of IBI363 in Colorectal Cancer Under Takeda Collaboration

Key Words: IBI363, PD-1/IL-2, bispecific antibody, colorectal cancer, Phase III, Innovent, Takeda

• The News: Innovent Biologics has registered a Phase III clinical trial evaluating IBI363 combined with bevacizumab in patients with advanced colorectal cancer who failed or are intolerant to standard therapy. The trial is the second Phase III study for IBI363, which is part of a US$ 11.4 billion global collaboration with Takeda that included a US$ 1.2 billion upfront payment.
• Key Highlights:
• Clinical Data:
  • Study Design: randomized, open-label, multicenter Phase III trial enrolling 550 subjects, comparing IBI363 plus bevacizumab against investigator’s choice.
  • Primary Endpoint: overall survival (OS).
  • Secondary Endpoints: investigator-assessed PFS, ORR, DoR, DCR, TTR per RECIST v1.1, plus safety, PK and immunogenicity.
• Product Profile – IBI363:
  • IBI363: a PD-1/IL-2α-bias bispecific antibody fusion protein that blocks PD-1/PD-L1 and activates IL-2 pathways.
  • Mechanism: engineered IL-2 arm retains IL-2Rα affinity while reducing IL-2Rβ/γ binding to lower toxicity; PD-1 arm enables simultaneous PD-1 blockade and selective IL-2 delivery.
  • Indication Focus: advanced colorectal cancer; also in global Phase III for immune-resistant squamous non-small cell lung cancer.
  • Development Stage: Phase III (second Phase III trial initiated).

Innovent Biologics (1801.HK) Files IND for INHBE siRNA

Key Words: INHBE, siRNA, obesity, GLP-1, combination, weight loss, IND

• The News: Innovent Biologics has submitted a clinical trial application to the NMPA for IBI3046, an INHBE siRNA. Preclinical data presented at ADA 2026 showed IBI3046 monotherapy achieved 13% weight loss and 50% fat reduction in a humanized mouse model, while combination with low-dose GLP-1 induced 20% weight loss with 70% fat reduction, matching high-dose GLP-1 efficacy.
• Key Highlights:
• Clinical Data:
  • Study Design: INHBE humanized mouse model, 9 mg/kg QW x 4 weeks.
  • Efficacy: 13% weight loss, 50% fat reduction (monotherapy); 20% weight loss, 70% fat reduction (combination with low-dose GLP-1).
• Product Profile – IBI3046:
  • IBI3046: an INHBE siRNA designed to target a conserved human-monkey sequence region.
  • Mechanism: silences INHBE expression through RNA interference to modulate liver-derived metabolic pathways, promoting fat reduction and enhancing weight-loss effects, particularly in combination with GLP-1 therapies.
  • Indication Focus: Primarily focused on obesity and weight management, with potential applications in broader metabolic diseases, including obesity-related metabolic dysfunction.
  • Development Stage: Preclinical; IND application submitted to China’s NMPA, with encouraging preclinical weight-loss data supporting further clinical development.

BriSTAR’s Allogeneic STAR-T Product YTS109 Clears US FDA IND for AIHA

Key Words: BriSTAR, YTS109, STAR-T, allogeneic, CD19, AIHA, IND, autoimmune

• The News: BriSTAR Immunotech received US FDA IND clearance for YTS109, a site-specific integrated allogeneic CD19 STAR-T cell therapy for autoimmune haemolytic anaemia (AIHA). The clearance follows a RMB 200 million (US$ 30 million) Series C financing and marks the platform’s expansion from oncology into autoimmune indications.
• Key Highlights:
• Clinical Data:
  • Study Design: prior exploratory data in severe autoimmune diseases; AIHA cohort showed 100% complete remission rate.
  • Efficacy: sustained responses over 18 months in systemic lupus erythematosus (SLE) with lupus nephritis.
  • Regulatory Status: US FDA IND cleared for AIHA.
• Product Profile – YTS109:
  • YTS109: a site-specific integrated allogeneic CD19 STAR-T cell therapy using CRISPR-based editing for precise TCR locus integration.
  • Mechanism: fuses CAR antigen recognition with natural TCR signalling to enhance tissue infiltration, sensitivity, and safety while reducing off-target activation.
  • Indication Focus: autoimmune haemolytic anaemia (AIHA).
  • Manufacturing: enables scalable, off-the-shelf production via CRISPR editing, avoiding random viral insertion risks.
• BriSTAR Immunotech: a China-based biotech developing allogeneic STAR-T cell therapies for oncology and autoimmune diseases using its proprietary Synthetic T-Cell Receptor and Antigen Receptor platform.

Vincentage Files First Domestic Oral GLP-1 Agonist in China

Key Words: GLP-1, obesity, oral small molecule, NDA, Phase III, weight reduction, Vincentage

• The News: Vincentage has submitted a New Drug Application to China’s CDE for VCT220, an oral non-peptide small-molecule GLP-1 receptor agonist, making it the first domestically developed candidate of its class to reach the NDA stage.
• Key Highlights:
• Clinical Data:
  • Efficacy: Mean weight loss 12.2% (120 mg) and 12.4% (160 mg) vs 1.3% placebo at week 52.
  • Safety: Mostly mild gastrointestinal events; discontinuation rates 1.8% in both active arms; no hepatic safety signals; no fasting, fixed timing, or cold-chain storage required.
• Product Profile – VCT220:
  • VCT220: an oral, non-peptide small-molecule GLP-1 receptor agonist for long-term obesity management.
  • Mechanism: Activates GLP-1R signaling to enhance insulin secretion, suppress appetite, delay gastric emptying, and improve metabolic control, while offering the convenience of oral dosing compared with injectable GLP-1 therapies.
  • Indication Focus: Obesity and potentially broader metabolic disorders, including type 2 diabetes.
  • Development Stage: NDA filed in China; Corxel Pharmaceuticals secured ex-Greater China rights in December 2025.
• Vincentage: a Chinese biopharmaceutical company developing oral small-molecule GLP-1 receptor agonists for metabolic diseases.

MediLink Therapeutics Files B7-H3 ADC as First Phase III-Proven Candidate Globally

Key Words: B7-H3, ADC, MediLink, tambotatug pelitecan, nasopharyngeal carcinoma, NDA, TAISHAN-301, Roche

• The News: MediLink Therapeutics submitted an NDA to China’s CDE for tambotatug pelitecan, a B7-H3-targeted ADC using the TMALIN linker platform, in recurrent or metastatic nasopharyngeal carcinoma after PD-1/L1 failure and ≥2 prior chemotherapies.
• Key Highlights:
  • January 2026 exclusive global licence (ex-China, Hong Kong, Macau) with Roche; US$ 570 million upfront and near-term milestones, plus development, regulatory, commercial milestones and tiered royalties.
• Product Profile – Tambotatug Pelitecan (YL201):
  • Tambotatug Pelitecan (YL201): a B7-H3-targeted ADC developed by MediLink Therapeutics using the TMALIN® linker-payload platform for advanced solid tumors.
  • Mechanism: targets B7-H3-expressing tumor cells and delivers a TopoI inhibitor payload through ADC-mediated internalization, inducing DNA damage and tumor cell death.
  • Indication Focus: recurrent/metastatic nasopharyngeal carcinoma after PD-1/L1 inhibitor and chemotherapy failure, with potential expansion across B7-H3-positive cancers.
  • Development Stage: Phase III validated; TAISHAN-301 achieved positive results, supporting NDA submission in China.
• Clinical Data:
  • Study Design: Phase III randomized controlled trial evaluating tambotatug pelitecan (YL201) in recurrent/metastatic NPC patients after PD-1/L1 inhibitor and chemotherapy failure.
  • Primary Endpoint: BICR-assessed ORR.
  • Key Result: demonstrated positive Phase III efficacy results, making YL201 the first B7-H3 ADC globally with pivotal Phase III validation.
  • Supports NDA filing in China and highlights the potential of B7-H3 ADCs as a new treatment strategy for advanced NPC.
• MediLink Therapeutics: China-based biotech developing ADCs with its proprietary TMALIN tumour-microenvironment-cleavable linker platform.

Innovent Biologics (1801.HK) and Gan & Lee Pharmaceuticals File Oral Weekly GLP-1 Agents for Human Trials

Key Words: GLP-1, oral weekly, small molecule, peptide, obesity, diabetes, IND

• The News: Innovent Biologics received NMPA IND acceptance for IBI3042, the first oral once-weekly small-molecule GLP-1 receptor agonist to enter clinical development, while Gan & Lee Pharmaceuticals filed a clinical trial application for GZC8072, an oral weekly formulation of its bofanglutide peptide backbone.
• Key Highlights:
• Product Profile – IBI3042:
  • IBI3042: an oral once-weekly small-molecule GLP-1 receptor agonist developed by Innovent for obesity and metabolic diseases.
  • Mechanism: activates GLP-1R signaling to enhance insulin secretion, suppress appetite, and improve metabolic control, offering a potential oral alternative to injectable GLP-1 therapies.
  • Indication Focus: obesity, weight management, and cardiometabolic diseases.
  • Development Stage: IND accepted by NMPA; first domestic oral weekly small-molecule GLP-1 candidate entering clinical development.
• Product Profile – GZC8072:
  • GZC8072: An oral once-weekly GLP-1 receptor agonist peptide formulation based on Gan & Lee’s bofanglutide platform.
  • Mechanism: Activates GLP-1R to regulate glucose metabolism and appetite while leveraging oral weekly dosing to improve treatment convenience.
  • Indication Focus: Type 2 diabetes and obesity.
  • Development Stage: clinical trial application filed.

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