This week, biotech highlights include Xinji Pharmaceutical’s RMB 1.53B Hong Kong IPO (microneedle, transdermal), CSPC’s RMB 1.18-1.36B H1 profit driven by AstraZeneca’s US$420M payment (CLDN18.2 ADC), Caldera-Synlogic’s merger with US$278M financing (CLD-423), and Siyomicro’s nine-figure RMB financing (AI+BT platform).

Transactions & BD (In/Out Licensing)

Xinji Pharmaceutical Advances Toward Hong Kong IPO with Valuation Around RMB 1.53 Billion

Key Words: Xinji Pharmaceutical, IPO, microneedle, nasal inhalation, modified-release drug, CNS, Parkinson’s disease, transdermal delivery

• The News: Guangzhou Xinji Pharmaceutical, a modified-release drug developer, filed an H-share listing application with the Hong Kong Stock Exchange. The company, backed by roughly RMB 290 million in cumulative funding, targets transdermal and central nervous system therapies via its soluble microneedle and nasal inhalation platforms.
• Key Highlights:
• Deal Details:
  • IPO Status: H-share application submitted to Hong Kong Stock Exchange main board.
  • Financing History: Cumulative funding of approximately RMB 290 million from investors including Guangzhou Pharmaceutical Capital, Yuesiu Danlu, and Zhejiang Venture Capital.
  • Latest Valuation: implied valuation of RMB 1.53 billion after Series C round in November 2025.
  • Financial Profile: 2024 revenue of RMB$ 49.03 million with net loss of RMB$ 145 million; revenue primarily from CRO services.
• Platform Profile – Soluble Microneedle Technology:
  • PlatformName: Soluble microneedle patches using micron-scale needle arrays to dissolve and release drugs through the skin, replacing traditional injections
  • Mechanism: Microneedles penetrate the stratum corneum for painless, minimally invasive transdermal delivery
  • Lead Asset: Dexmedetomidine hydrochloride microneedle patch, the only soluble microneedle drug patch in China in Phase II trials, for pediatric and adult preoperative sedation.
• Xinji Pharmaceutical: A Guangzhou-based modified-release drug developer founded in 2007 by Dr. Wu Chuanbin, focusing on soluble microneedle and nasal inhalation platforms for transdermal and CNS indications.

CSPC Innovation Pharmaceutical (300765.SZ) Swings to Profit After Receiving US$ 420 Million Upfront from AstraZeneca (LON: AZN)

Key Words: CSPC Innovation Pharmaceutical, AstraZeneca, SYSA1801, ADC, Claudin 18.2, gastric cancer, licensing, US$ 420 million

• The News: CSPC Innovation Pharmaceutical reported a net profit attributable to shareholders of RMB 1.18 billion to RMB 1.36 billion for the first half of 2026, reversing a year-ago loss. The turnaround was driven by the full receipt of a US$ 420 million upfront payment from AstraZeneca under a strategic collaboration for innovative peptide drug discovery.
• Key Highlights:
• Deal Details:
  • 2026H1 Net Profit: Expected to reach RMB 1.18-36 billion, supported by licensing revenue recognition and commercial growth of innovative products.
  • AstraZeneca provided a US$420 million upfront payment, which was fully received by Giantstone on May 29, 2026.
• Core Product – SYSA1801:
  • SYSA1801: an antibody-drug conjugate targeting Claudin 18.2, a tumor-associated antigen highly expressed in gastric cancer and other solid tumors.
  • Mechanism: conjugated with a cytotoxic payload, the ADC is internalized and releases the payload intracellularly, inducing DNA damage and tumor cell apoptosis.
  • Indication Focus: CLDN18.2-positive gastric/gastroesophageal junction cancer and potential expansion into pancreatic cancer and other CLDN18.2-expressing solid tumors.
  • Development Stage: clinical-stage ADC program with global development potential.

Caldera Therapeutics and Synlogic (OCTMKTS: SYBX) Merge to Advance IL-23p19/TL1A Bispecific CLD-423 with US$ 278 Million Financing

Key Words: Caldera, Synlogic, CLD-423, IL-23p19, TL1A, bispecific, ulcerative colitis, Crohn’s disease, financing, merger

• The News: Caldera Therapeutics and Synlogic agreed to merge in an all-stock transaction, with the combined company to operate as Caldera and list on Nasdaq under “CALD”. Caldera secured about US$ 278 million in a concurrent private placement funding CLD-423 through 2029.

Caldera holds exclusive worldwide rights under a licence from China-based Qyuns Therapeutics. Pre-merger Synlogic stockholders will hold approximately 2.3% of the combined company, with Caldera stockholders at 62.8% and institutional investors at 34.9%.

• Key Highlights:
• Deal Details:
  • Total Transaction Size: US$ 278 million private placement, with post-money valuation of about US$ 800 million.
  • Pre-merger Synlogic shareholders to hold about 2.3%, pre-merger Caldera shareholders about 62.8%, and new investors about 34.9%.
  • Financing History: Caldera raised US$ 75 million Series A in April 2025 from Atlas Venture, LAV and venBio, plus US$ 37.5 million Series A-1 from Omega Funds.
• Product Profile – CLD-423:
  • CLD-423: A bispecific antibody targeting IL-23p19 and TL1A, designed to combine both mechanisms in one molecule for potentially greater efficacy than single-target standard of care.
  • Mechanism: Engineered with natural IgG structure and monovalent 1+1 format to reduce TL1A-based immunogenicity, plus YTE half-life extension mutations for competitive dosing.
  • Indication Focus: Phase 2 development in ulcerative colitis and Crohn’s disease, with potential expansion to other immune-mediated diseases.
  • Development Stage: Preclinical to Phase 2-ready, with funding expected to support operations until 2029.

Siyomicro Completes Nine-Figure Financing Round to Strengthen AI Plus BT Synthetic Biology Platform and Expand into Bulk Biomanufacturing Products

Key Words: Siyomicro, synthetic biology, AI+BT, biomanufacturing, microbial chassis, enzyme engineering, fermentation, financing

• The News: Shenzhen-based Zhongke Xinyang Biotechnology has completed a RMB 100 million+ financing round led by strategic industrial investors. The proceeds will be used to further develop its AI+BT synthetic biology platform, accelerate multi-chassis cell engineering and product commercialization.
• Key Highlights:
• Deal Details:
  • Financing Size: nine-figure RMB round, with follow-on funding planned and Kaicheng Capital serving as financial advisor.
  • Investor Base: led by an industrial investor, joined by Haiyuan Capital and Longgang Guidance Fund.
  • Use of Funds: platform buildout, multi-chassis cell development, and industrialization of bulk biobased products.
• Platform Profile – AI+BT Synthetic Biology Platform:
  • Platform Overview: integrates a synthetic biology intelligent computing platform, biochip platform, and high-throughput automation platform for rapid R&D iteration.
  • Database: 8 million proprietary extreme-enzyme elements, with 93% of sequences absent from international public databases.
  • Chassis Technology: proprietary filamentous fungal chassis with recombinant protein secretion, gene editing tools, and controlled fermentation processes.
• Siyomicro: A Shenzhen-based synthetic biology company commercializing high-value ingredients across personal care, functional nutrition, and flavors, now extending into bulk biomanufacturing.

Asymchem Biologics (002821.SZ) Completes RMB 1.24 Billion Financing at RMB 4.24 Billion Valuation with Hillhouse Capital Participation

Key Words: Asymchem Biologics, Hillhouse Capital, CDMO, biologics, financing, IPO, RMB 4.24 billion

• The News: Asymchem Biologics, a subsidiary of Asymchem Laboratories, signed a capital increase agreement with the listed parent, Hillhouse Capital, and founder Dr. Hong Hao, raising RMB 1.24 billion at a post-money valuation of RMB 4.24 The proceeds will fund the biologics CDMO’s operations and capital expenditures, with a commitment to complete a qualified IPO within four years or trigger a repurchase at an 8% annual simple interest rate.
• Key Highlights:
• Deal Details:
  • Total Deal Value: RMB 1.24 billion, with Asymchem contributing RMB 1.05 billion, Hillhouse RMB 177 million, and Dr. Hong RMB 12.7 million.
  • Pre-money Valuation: RMB 3 billion; post-money valuation RMB 4.24 billion.
  • Repurchase Clause: IPO required within four years, otherwise buyback at 8% annual simple interest.
• Financial Profile:
  • 2025 Revenue: RMB 469 million, with a net loss of RMB 43.77 million
  • Q1 2026 Revenue: RMB 140 million, with a net loss of RMB 22.79 million
• Asymchem Biologics: a biologics CDMO subsidiary of Asymchem Laboratories, focused on large-molecule development and manufacturing services, based in China.

Puqi Pharmaceutical Files for Hong Kong IPO at RMB 1.8 Billion Valuation

Key Words: IPO, JAK inhibitor, topical, atopic dermatitis, allergic rhinitis, commercialization, licensing

• The News: Beijing-based Puqi Pharmaceutical submitted a Hong Kong IPO application at a valuation of RMB 1.8 billion, following prior licensing deals with Simcere Pharmaceutical (2096.HK) and Jumpcan Pharmaceutical. The company has yet to commercialize any product, with net losses of RMB 178 million in 2024 and RMB 141 million in 2025.
• Key Highlights:
• Deal Details:
  • IPO valuation set at RMB 1.8 billion; filing submitted to the Hong Kong Stock Exchange.
  • Simcere secured exclusive promotion rights for pumicitinib gel across all dermatology indications in mainland China, Hong Kong, and Macau on June 1, 2026.
  • Jumpcan locked exclusive commercialization rights for the nasal spray in Greater China on January 30, 2026, for up to RMB 100 million in upfront and milestone payments.
• Product Profile – Pumicitinib Gel:
  • Pumicitinib gel: a topical JAK inhibitor designed for low systemic exposure, targeting atopic dermatitis and other chronic inflammatory skin conditions.
  • Mechanism: locally acting JAK inhibition to reduce inflammation while avoiding oral JAK systemic toxicity risks.
  • Indication Focus: atopic dermatitis, with the market projected to grow from RMB 13.2 billion in 2025 to RMB 48.4 billion by 2033.
  • Development Stage: NDA accepted for review; regulatory scrutiny on topical JAK inhibitors has intensified after Hengrui withdrew its similar application and Minghui’s product remains unapproved.
• Puqi Pharmaceutical is a Beijing-based clinical-stage biotech developing topical targeted anti-inflammatory drugs, including gels, nasal sprays, and eye drops.

IMPACT Therapeutics (07630.HK) Signs Exclusive License Agreement with Pharmanovia for Senaparib

Key Words: IMPACT Therapeutics, Pharmanovia, senaparib, PARP1/2 inhibitor, ovarian cancer, licensing, EMA, Europe, MENA, Australia, New Zealand

• The News: IMPACT Therapeutics has partnered with Pharmanovia to grant exclusive manufacturing, development, and commercialization rights for senaparib in 66 countries, including Europe, the Middle East, North Africa, Australia, and New Zealand. The deal is valued at up to EUR 423.5 million, including milestone payments and royalties. The EMA accepted the Marketing Authorisation Application (MAA) for senaparib as a first-line maintenance therapy for advanced ovarian cancer in August 2025, with approval expected in the second half of 2026.
• Key Highlights:
• Deal Value: Up to EUR 423.5 million, including upfront, regulatory, and commercial milestone payments, plus tiered royalties up to the mid-twenties (%).
  o Global Reach: Territories include EU member states, the UK, Norway, Iceland, Switzerland, Australia, New Zealand, and select Middle Eastern and North African countries.
• Product Profile – Senaparib (IMP4297):
  • Mechanism: A highly potent PARP1/2 inhibitor with excellent target selectivity and a wide safety window.
  • Indication: Maintenance therapy for advanced ovarian, fallopian tube, and primary peritoneal cancer in patients responding to platinum-based chemotherapy.
  • Milestones:
  • Approved in China (January 2025) and included in the NRDL (December 2025).
  • EMA approval expected in H2 2026.

Clinical

GSK (GSK.N) and Siran Bio Enter US$ 1.01 Billion Licensing Deal as ALK7-Targeting siRNA Therapy SA030 Wins China Clinical Trial Approval

Key Words: GSK, Siran Bio, SA030, ALK7, siRNA, obesity, licensing, clinical trial

• The News: Siran Bio announced that its investigational SA030 injection, a first-in-class siRNA candidate targeting ALK7, received clinical trial approval from China’s CDE. This follows a May 2026 exclusive licensing agreement with GSK, which includes upfront and milestone payments totaling up to US$ 1.01 billion plus tiered royalties on global net sales excluding Greater China.
• Key Highlights:
• Deal Details:
  • GSK will pay upfront and milestone payments up to US$ 1.01 billion, plus tiered royalties on global net sales excluding Greater China.
  • Shian Bio will lead clinical development through Phase I completion; GSK then assumes development, regulatory, and commercialization duties outside Greater China.
• Clinical Data:
  • Study Design: a randomized, double-blind, placebo-controlled Phase I study in Australia, initiated after HREC ethics approval in February 2026.
  • Preclinical data show long-acting effects via adipose-targeted delivery and low-frequency dosing, with a mechanism complementary to GLP-1 agonists and SGLT2 inhibitors.
  • The candidate was selected for an oral presentation at the 86th ADA Scientific Sessions in June 2026.
• Product Profile – SA030:
  • SA030: a long-acting siRNA drug developed on Shian Bio’s proprietary STORK-F adipose-targeting delivery platform.
  • Mechanism: RNA interference precisely silences ALK7 mRNA, blocking a pathogenic pathway linked to fat accumulation and insulin resistance.
  • Indication Focus: obesity and related cardiometabolic diseases; ALK7 is a TGF-β type I receptor highly expressed in white and brown adipose tissue.

Huahai Pharmaceutical (600521.SH) Wins First Innovative Drug Approval for IL-36R Antibody HB0034 in China

Key Words: Huahai Pharmaceutical, Huaota Biologics, HB0034, recibokibart, Huayijing, IL-36R, generalized pustular psoriasis, GPP, China

• The News: China’s NMPA approved Huahai Pharmaceutical’s subsidiary Huaota Biologics’ HB0034, an anti-IL-36R monoclonal antibody with the INN “recibokibart” and trade name “Huayijing” . This marks Huahai’s first self-developed innovative drug to reach the market and the first domestically produced IL-36R antibody in China, following Boehringer Ingelheim’s spesolimab.
• Key Highlights:
• Clinical Data:
  • Pivotal Phase II trial met primary and all key secondary efficacy endpoints; a single IV dose cleared skin pustules by week 1 vs. placebo.
  • Safety profile was favorable with no new safety signals.
• Product Profile – HB0034 (recibokibart):
  • HB0034: a humanized IgG1 monoclonal antibody targeting IL-36R with high affinity, competitively blocking IL-36α, β, and γ binding.
  • Mechanism: inhibits IL-36 inflammatory signaling, reducing pathogenic cytokine release in autoinflammatory diseases.
  • Indication Focus: generalized pustular psoriasis (GPP), a rare, life-threatening neutrophilic skin disease; ~20,000 patients in China.
  • Development Stage: approved in China; FDA orphan drug designation granted in the U.S.

Biokin Pharmaceutical (688506.SH) Initiates Phase 2/3 Trial of PD-1/VEGF Bispecific Plus EGFR/HER3 ADC for First-Line NSCLC

Key Words: Biokin, BL-B01D1, EGFR/HER3 ADC, PD-1/VEGF, NSCLC, phase 2/3

• The News: Biokin Pharmaceutical registered two phase 2/3 trials on Clinicaltrials.gov for BL-B01D1 combined with a PD-1/VEGF bispecific antibody as first-line treatment. The regimen extends IO+ADC combinations into first-line settings, with BL-B01D1 recently approved and partner Bristol Myers Squibb (BMY.N) launching a global phase 3 trial in EGFR-mutant NSCLC.
• Key Highlights:
• Clinical Data:
  • Study Design: two phase 2/3 trials, first-line, locally advanced or metastatic squamous and non-squamous NSCLC.
  • Context: the first-in-class EGFR/HER3 ADC with a TOPO1 inhibitor payload and DAR of 8.
  • Safety: shows notable toxicity, potentially limiting broad clinical adoption despite efficacy.
• Product Profile – BL-B01D1:
  • BL-B01D1: A first-in-class EGFR×HER3 bispecific ADC developed by Biokin and SystImmune for EGFR/HER3-expressing solid tumors.
  • Mechanism: dual targeting of EGFR and HER3 enables enhanced tumor-cell binding and internalization, delivering a TopoI inhibitor payload to induce DNA damage and tumor cell death.
  • Indication Focus: NSCLC, nasopharyngeal carcinoma, and other EGFR/HER3-positive solid tumors.
  • Development Stage: commercialized in China for advanced NPC; Phase II/III studies ongoing in NSCLC and other solid tumors with global development supported by BMS.

Kelun Pharmaceutical (002422.SZ) Files New NDA for TROP2 ADC (sac-TMT) for First-Line TNBC in China

Key Words: Kelun, SKB264/MK-2870, TROP2 ADC, sac-TMT, TNBC, NDA

• The News: Kelun Pharmaceutical’s subsidiary, Kelun Biotech, submitted a New Drug Application (NDA) to the China National Medical Products Administration (NMPA) for sac-TMT (SKB264/MK-2870), a TROP2-targeted ADC. The application focuses on its use as a first-line treatment for recurrent or metastatic triple-negative breast cancer (TNBC) with PD-L1 CPS < 10 or patients previously treated with PD-1/PD-L1 inhibitors.
• Key Highlights:
• Clinical Data:
  • Study Design: Phase 3 OptiTROP-Breast03 trial in advanced, recurrent, or metastatic TNBC (nonsurgical), comparing sac-TMT with investigator-selected chemotherapy.
  • Results: Demonstrated significant clinical benefit and statistical improvement in efficacy over chemotherapy in targeted TNBC populations.
• Regulatory Milestones:
  • The sixth NDA submission for sac-TMT in China, with Prioritized Evaluation Program approval.
  • Previously granted Breakthrough Therapy Designation (BTD) for TNBC with PD-L1-negative profiles.
• Product Profile – sac-TMT:
  • sac-TMT (SKB264/MK-2870): A TROP2 ADC developed by Kelun Biotech and licensed to Merck (outside Greater China).
  • Mechanism: Dual-functional linker delivering the TopoI inhibitor payload with a drug-to-antibody ratio (DAR) of 7.4, inducing tumor cell apoptosis via TROP2 targeting.
  • Current Status: Approved for four indications in China, with two already included in the NRDL (National Reimbursement Drug List).

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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