Transactions & BD (In/Out Licensing)

Duality Biotherapeutics (9606.HK) Files for STAR Market IPO, Seeking to Raise RMB 4.1 Billion

Key Words: Duality Biotherapeutics, ADC, IPO, STAR Market, HER2 ADC, B7-H3 ADC, BioNTech, GSK

• The News: On June 12, 2026, Duality Biotherapeutics submitted its IPO application for the STAR Market, aiming to raise RMB 4.1 billion. Founded in 2019 in Suzhou BioBAY with a Cayman Islands registration, the company specializes in antibody-drug conjugates (ADC), often referred to as “biological missiles” for their tumor-targeting precision. Duality stands out globally with four proprietary ADC platforms and a pipeline of 10 clinical-stage candidates spanning 20 countries.
• Key Highlights:
• Pipeline Leadership:
  • DB-1303 (HER2 ADC): NDA accepted in China for HER2-positive breast cancer; global Phase III trial for HER2-low breast cancer is complete, positioning it as a likely first-in-class treatment.
  • DB-1311 (B7-H3 ADC): One of only two global B7-H3 candidates in Phase III trials, with Duality leading in China and holding global second place.
  • DB-2304 (B7-H3 for autoimmune diseases): Expanding ADC applications beyond oncology with the world’s first B7-H3 ADC targeting autoimmune conditions.
• Key Partners: BioNTech, GSK, BeiGene.
• Notable Deals:
  • DB-1303 and DB-1311 licensed to BioNTech for US$ 1.7 billion upfront with a total deal value of USD 16.5 billion.
  • CDH17 ADC (DB-1324) licensed to GSK for a US$ 30 million upfront payment.
  • B7-H4 ADC (DB-1312) licensed to BeiGene.
• Financial Overview:
  • Revenue relies heavily on partnership payments (BD income):
  • 2023: 98.86% of RMB 1.78 billion revenue derived from a single USD 170 million upfront payment from BioNTech.
  • 2025 revenue declined slightly due to fewer new deals being signed.
  • R&D investment: RMB 21.18 billion over three years, averaging RMB 7 billion annually.
  • Loss gap: Huge disparity between net loss (RMB -26.06 billion for 2025) and adjusted net profit (RMB -4.11 billion), largely due to non-cash expenses like equity incentives.

Alebund Pharmaceuticals Passes Hearing, Set to Become Hong Kong’s “First CKD Stock”

Key Words: Alebund Pharmaceuticals, chronic kidney disease, high phosphate, IPO, AP301, high phosphorus, CKD, MRCT

• The News: On June 14, 2026, Alebund Pharmaceuticals-B cleared its hearing with the Hong Kong Stock Exchange (HKEX) and is preparing for a mainboard IPO. Joint sponsors include Jefferies, BofA Merrill Lynch, and Huatai International. The company, established in 2018, specializes in biopharmaceuticals focused on chronic kidney disease (CKD).
• Key Highlights:
• Commercial Product – MIRCERA®: Licensed from Roche as a long-acting erythropoiesis-stimulating agent (EPO), approved for CKD anemia.
• Core Product – AP301 (Phosphate Binder):
  • Acquired global rights from Vidasym in 2021.
  • Targets hyperphosphatemia, a common complication in CKD with significant unmet medical needs.
  • Completed a Phase III trial in China and is preparing to submit a New Drug Application (NDA).
  • Currently conducting global Phase III multi-center trials (MRCT) in China and the U.S.
• Pipeline:
  • AP306: A pan-phosphate transport protein inhibitor licensed from Japan’s Chugai Pharmaceutical, already granted Breakthrough Therapy Designation (BTD) in China for hyperphosphatemia.
  • AP303: A disease-modifying drug aimed at delaying CKD progression, with Orphan Drug Designation (ODD) granted by the U.S. FDA for autosomal dominant polycystic kidney disease (ADPKD).
  • AP308: IgA protease targeting functional cures for IgA nephropathy (IgAN), developed using technology licensed from Peking University.
• Financial Overview:
  • Revenue: RMB 7 million in 2024; RMB 31 million in 2025.
  • Losses: RMB 335 million net loss in 2024, increasing to RMB 752 million in 2025 due to high R&D expenditures.
  • Cash Flow: Operating cash flow of RMB -288 million in 2025, cash reserves of RMB 358 million at the end of 2025.

Vitalgen Biopharma’s IPO Application Accepted for STAR Market

Key Words: Vitalgen Biopharma, gene therapy, STAR Market, IPO, AADC deficiency, BCD

• The News: Recently, the Shanghai Stock Exchange officially accepted Vitalgen Biopharma’s application for a STAR Market IPO. The company plans to issue 60 million shares, aiming to raise RMB 2.503 billion, with a post-investment valuation of approximately RMB 4.3 billion. Founded in 2020, Vitalgen focuses on gene therapies for rare and degenerative diseases and has already completed several rounds of financing from notable investors such as IDG Capital, Hillhouse, and others.
• Key Highlights:
• VGN-R09b (AADC Deficiency):
  • Gene therapy using rAAV to treat Aromatic L-Amino Acid Decarboxylase (AADC) deficiency, a rare pediatric disorder with high mortality.
  • Currently in Phase III trials, with expected regulatory filings in China by 2027. The program also targets Parkinson’s disease, with Phase III trials anticipated to begin in China and the U.S. by 2026.
• VGR-R01 (BCD):
  • World’s first gene therapy for crystalline retinopathy (BCD) to reach registration stage.
  • Completed Phase III trials with expected NDA submission in China.
• Financial Performance:
  • The company has not yet commercialized any products, generating RMB 21.68 million in revenue in 2025 from licensing and technical services.
  • Cumulative losses from 2023 to 2025 are approximately RMB 714 million, driven by over RMB 600 million in R&D expenditures.
  • As of 2025, Vitalgen holds RMB 1.164 billion in cash reserves, ensuring short-term financial stability.

Harbour BioMed (2142.HK) and BioMap Form Strategic Partnership to Launch AI Biologics Company

Key Words: Harbour BioMed, BioMap, AI drug discovery, biologics, MegaStream TechBio, FIC, BIC

• The News: On June 15, 2026, Harbour BioMed announced a strategic partnership with BioMap to jointly establish MegaStream TechBio, an AI-powered platform for the development of complex biologic drugs. The collaboration aims to leverage AI technologies and integrate biologics expertise to systematically accelerate the development of next-generation therapies targeting major unmet clinical needs.
• Key Highlights:
• Focus Areas:
  • Cardiovascular and renal diseases (CVRM), central nervous system (CNS) disorders, aging-related conditions, and metabolic diseases were selected as priority targets due to their substantial unmet clinical needs.
  • With chronic diseases affecting over 2 billion people globally and causing significant economic burdens, the partnership emphasizes first-in-class (FIC) and best-in-class (BIC) innovation in complex biologics.
• MegaStream TechBio Objectives:
  • Integrate Harbour BioMed’s expertise in fully human antibody platforms, target validation, and clinical development with BioMap’s cutting-edge AI foundation models.
  • Build an AI-driven pipeline with hundreds of differentiated molecules, designed to enhance drug performance and enable faster clinical entry.
• Technology Infrastructure:
  • Data & Models: Harbour BioMed’s proprietary dataset of millions of NGS HCAb sequences forms the foundation for BioMap’s AI. Iterative training with BioMap’s life science large models ensures personalized, scalable AI innovations tailored for complex biologics.
  • High-throughput Labs: A new-generation “design-build-test-learn” automated wet-dry lab platform is expected to enhance data processing and analysis efficiency by more than 500% and generate over 5 petabytes of AI-ready data in the next five years.
• Pipeline – LET003 (ActRIIA/B Antibody):
  • Earlier in May, Harbour BioMed unveiled preclinical data for LET003, an AI-designed ActRIIA/B antibody. The molecule demonstrated superior pharmacokinetics, increased lean body mass at low doses, and synergistic potential in obesity treatment when combined with semaglutide.

Dimerix Exclusively Licenses DMX-200 in Greater China, South Korea, and Southeast Asia to Everest Medicines

Key Words: Dimerix, Everest Medicines, DMX-200, FSGS, Phase 3, Licensing Deal, Greater China, Southeast Asia

• The News: Dimerix Limited (ASX: DXB) has announced an exclusive licensing agreement with Everest Medicines for the commercialisation of its Phase 3 candidate DMX-200 for Focal Segmental Glomerulosclerosis (FSGS) across Greater China, South Korea, and Southeast Asia. The agreement provides Everest Medicines with exclusive rights to develop and commercialise DMX-200 in these regions, while Dimerix retains rights for unlicensed territories.
• Key Highlights
• Financial Terms:
  • Upfront Payment: US$10 million (approximately AU$14.1 million).
  • Milestone Payments: Up to US$330 million (AU$467 million).
  • Royalties: Tiered rates of 10-15% on net sales in the licensed regions.
• DMX-200 Development:
  • DMX-200 is currently in the pivotal ACTION3 Phase 3 trial for FSGS, a severe kidney disease with no approved therapies in the relevant territories.
  • The ACTION3 trial is fully recruited, with 333 patients enrolled across 21 countries, including mainland China, Thailand, and Malaysia.
• Everest Medicines, leveraging its expertise in kidney diseases, aims to accelerate access to DMX-200 for underserved patient populations in the licensed regions.

Legend Biotech (LEGN.O) Announces Proposed Public Offering

Key Words: Legend Biotech, Public Offering, American Depositary Shares, Cell Therapy, SEC, Morgan Stanley, Jefferies, Citigroup, Deutsche Bank Securities

• The News: Legend Biotech, a global leader in cell therapy, has announced the commencement of an underwritten public offering of US$ 225 million of American Depositary Shares (“ADSs”), each representing two ordinary shares of the Company. All ADSs will be offered by Legend Biotech, with an option for the underwriters to purchase an additional 15% of the ADSs within 30 days.

The offering, subject to market conditions, proceeds under a previously filed shelf registration statement with the Securities and Exchange Commission (SEC). Morgan Stanley, Jefferies, Citigroup, and Deutsche Bank Securities are serving as joint book-running managers for the offering.

• Key Highlights
• Size of Offering: US$ 225 million, with an additional 15% option available to underwriters.
• ADS Details: Each ADS represents two ordinary shares of Legend Biotech.
• Purpose: The proceeds strengthen Legend Biotech’s position as a leader in cell therapy innovation.
• Management: The offering is being conducted under an effective SEC registration, with details available on the SEC website.

Clinical

BMS (BMY.N) Files Next‑Gen Molecular Glue Degrader Mezigdomide in China

Key Words: Bristol Myers Squibb, Mezigdomide, molecular glue degrader, cereblon modulator, relapsed or refractory multiple myeloma, Phase III SUCCESSOR-2 trial, NDA, China

• The News: Bristol Myers Squibb (BMS) has submitted a New Drug Application (NDA) in China for mezigdomide, a next-generation cereblon-modulating molecular glue degrader. The application covers its use with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma (r/r MM) in patients previously treated with lenalidomide and an anti-CD38 antibody.
• Key Highlights:
• Clinical Data:
  • Phase III SUCCESSOR-2 trial: Mezigdomide demonstrated a significant progression-free survival (PFS) benefit of 18.0 months versus 8.3 months (HR=0.48).
  • Objective Response Rate (ORR): Achieved 80.2% versus 53.4% in the control arm.
  • Safety: Manageable profile despite higher rates of Grade 3–4 neutropenia and infections.
• Drug Profile:
  • Mezigdomide: A novel degrader inducing targeted protein ubiquitination, going beyond enzyme inhibition.
  • Strategic Aim: Addresses unmet needs in heavily pre-treated myeloma patients and builds on BMS’s IMiD franchise.

Fosun’s (0656.HK) MEK Inhibitor Approved for Paediatric LCH with 90.5% ORR

Key Words: Fosun Pharmaceutical, luvometinib, MEK inhibitor, Langerhans cell histiocytosis, paediatrics, NMPA approval, MAPK pathway

• The News: Fosun Pharmaceutical has received approval from the National Medical Products Administration (NMPA) in China for a new indication for luvometinib, a selective MEK1/2 inhibitor, to treat children aged two and older with Langerhans cell histiocytosis (LCH).
• Key Highlights:
• Phase II trial in relapsed or refractory LCH demonstrated a 90.5% objective response rate (ORR) and a 69% complete metabolic remission (CMR) rate in 46 patients.
• Drug Profile – Luvometinib:
  • Mechanism of Action: Selectively inhibits MEK1/2, blocking abnormal MAPK pathway activation—the key driver of LCH.
  • Previous Approvals: Adult LCH/histiocytic tumours, and paediatric neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas.

Zelgen’s (688266.SS) JAK Inhibitor Secures Approval for Severe Alopecia Areata in China

Key Words: Zelgen Biopharm, gecacitinib, JAK inhibitor, alopecia areata, Phase III ZGJAK018 trial, SALT ≤20, China, TYK2

• The News: Zelgen Biopharm has received approval in China for gecacitinib, a pan-JAK (JAK1/2/3 and TYK2) inhibitor, for treating severe alopecia areata.
• Key Highlights:
• Phase III ZGJAK018 trial: Demonstrated a statistically significant proportion of patients achieving SALT ≤20 (≥80% scalp hair regrowth) at 24 weeks versus placebo.
• Drug Profile – Gecacitinib:
  • Unique Characteristics: Broad inhibition of all four JAK isoforms with additional observed benefits in promoting dermal papilla thickness and follicle regeneration.
  • Previous Approval: Approved in 2025 for myelofibrosis.
• Expanded Indications: Zelgen intends to further investigate gecacitinib in other autoimmune diseases.

Novo Nordisk (NOVO-B.CO) Launches Insulin/GLP-1 Combo Icosema Globally First in China

Key Words: Novo Nordisk, Kyinsu, insulin icodec, semaglutide, type 2 diabetes, GLP-1 RA, COMBINE 1 trial, China launch

• The News: Novo Nordisk has globally launched Kyinsu (insulin icodec + semaglutide), the first once-weekly fixed-ratio combination of basal insulin and a GLP-1 receptor agonist (GLP-1 RA), starting in China. The drug is approved for adults with type 2 diabetes (T2D) inadequately controlled on basal insulin or GLP-1 RA therapy.
• Key Highlights:
• Phase III COMBINE 1 trial: 72% of patients achieved HbA1c <7.0%, double the rate seen with basal insulin alone.
• Drug Profile – Kyinsu:
  • Components: Combines icodec (first once-weekly basal insulin) with semaglutide (widely prescribed GLP-1 RA).
  • Patient Benefits: Simplifies dosing with weekly injections to reduce daily burden, while addressing hypoglycaemia and weight gain concerns.
• Strategic Importance:
  • China as Launch Market: Reflects Novo Nordisk’s focus on China, co-developing the product with local leadership.
  • Trial Significance: First Novo multinational study led by a Chinese principal investigator.

Thederma’s Benvitimod Advances Treatment for Infant Atopic Dermatitis

Key Words: Thederma, benvitimod, atopic dermatitis, AhR modulator, EASI-90, infants, Phase III trial, Jumpcan Pharmaceutical

• The News: Thederma’s 1% benvitimod cream, a first-in-class non-hormonal AhR modulator, has achieved groundbreaking results in a Phase III trial for infants aged 3–24 months with atopic dermatitis (AD).
• Key Highlights:
• Clinical Results:
  • Efficacy: EASI-90 response rate of 81.6% and 77% Investigator’s Global Assessment (IGA) success rate.
  • Safety: Favourable profile with mild-to-moderate local reactions in only 7.3% of patients.
• Drug Profile – Benvitimod:
  • Mechanism: Restores skin barrier function and suppresses type 2 inflammation, addressing core drivers of AD.
  • Previous Approval: Approved in 2024 for children aged two and above; currently under regulatory review for infant use.
• Partnership: Thederma collaborates with Jumpcan Pharmaceutical, leveraging its expertise in paediatric and dermatology channels to enhance accessibility.

Abogen Biosciences Launches Phase III Trial for World’s First mRNA Shingles Vaccine

Key Words: Abogen Biosciences, mRNA vaccine, shingles, VZV, ABO1108, Phase III trial

• The News: On June 15, 2026, Abogen Biosciences registered the Phase III clinical trial for ABO1108, the world’s first mRNA vaccine for shingles (varicella-zoster virus, VZV). The trial has been officially listed on the Drug Clinical Trial Registration and Information Platform in China and will include 18,000 participants across four provinces.
• Key Highlights:
• Vaccine Candidate:
  • ABO1108 is a lyophilized mRNA-based vaccine developed to prevent shingles in adults aged 40 and above.
  • The vaccine will follow a two-dose regimen, administered 60 days apart, similar to recombinant shingles vaccines.
• Clinical Trial Details:
  • Trial Sponsor: Guangxi CDC, led by Director Huang Teng.
  • Trial Locations: Guangxi, Zhejiang, Hebei, and Shandong province CDCs.
  • Planned Enrollment: 18,000 participants.
• Founded in 2019, Abogen Biosciences is one of China’s earliest mRNA biotech companies, with a diversified pipeline targeting infectious diseases and oncology.

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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