This week’s China healthcare highlights include METiS TechBio’s US$148M cornerstone investment, led by BlackRock, as part of its Hong Kong IPO offering. Alebund Pharmaceuticals refiled for its US$200M Hong Kong IPO focused on renal diseases, while Impact Therapeutics launched a HK$910M Hong Kong IPO supported by cornerstone backers Tencent and Lilly Asia Ventures. GSK secured a US$1B global licensing deal with SiranBio for its siRNA-based ALK7-targeting SA030. Cabaletta Bio raised US$150M for its CD19 CAR-T therapy pipeline, and LTZ Therapeutics closed a US$38M oversubscribed financing for its U-MCE immunotherapy platform. Meanwhile, TenNor passed its HKEX listing hearing to advance its anti-infective portfolio, while InxMed partnered with Fosun for RMB1.12B to commercialize FAK inhibitors in China. These updates highlight China’s expanding role in biopharma innovation, licensing, and investment.

Transactions

METiS TechBio (7666.HK) Commences Hong Kong IPO with US$ 148 Million Cornerstone Investment Led by BlackRock

Key Words: METiS TechBio, IPO, HKEX, AI drug delivery, NanoForge, cornerstone investment, BlackRock

• The News: METiS TechBio has launched its Hong Kong IPO, seeking to raise over HK$ 10 billion through the global offering. The company has secured US$ 148 million in cornerstone investment commitments from 18 institutional investors, led by BlackRock with a US$ 50 million investment. Joint sponsors include Jefferies, Deutsche Bank and CITIC Securities, with listing expected on May 13, 2026.
• Key Highlights:
• Deal Details:
  • Offering size: Over HK$2.10 billion, with an offer price of HK$10.50 per share.
  • Cornerstone investors committed US$ 148 million, led by BlackRock with US$ 50 million.
  • Approximately 50% for AI platform development, 20% for clinical trials and 10% for animal health and anti-aging applications.
• Core Technology – NanoForge:
  • Proprietary AI-driven nano-delivery platform.
  • Integrates AiLNP, AiRNA and AiTEM to optimize lipid nanoparticle delivery, mRNA sequence design and small-molecule formulation.
• METiS TechBio is an AI-powered nano-delivery company using its NanoForge platform to design and optimize delivery systems for small-molecule, nucleic acid and mRNA therapeutics.

Alebund Pharmaceuticals Refiles for Hong Kong IPO with Focus on Kidney Diseases

Key Words: Alebund Pharmaceuticals, IPO, HKEX, kidney diseases, AP301, hyperphosphatemia, AP601, renal anemia

• The News: Alebund Pharmaceuticals has refiled its application for a Hong Kong IPO after its previous filing in October 2025. Founded in 2018, the company focuses on developing and commercializing therapies for kidney diseases. AP301 is expected to be submitted for regulatory approval in China in Q2 2026, while a global Phase III trial is ongoing to support a planned U.S. submission in Q3 2027.
• Key Highlights:
• IPO and Financials:
  • Around US$ 200 million through HK IPO, with Jefferies, BofA Securities and Huatai International acting as joint sponsors.
  • Reported a net loss of RMB 752 million in 2025 and a cash balance of RMB 358 million as of December 31, 2025.
  • AP601: a monthly erythropoiesis-stimulating agent licensed from Roche (RO.SW), is Alebund’ s sole commercialized product and generated RMB 30.56 million in revenue in 2025.
• AP301: an oral fiber-iron-based phosphate binder for hyperphosphatemia, with China NDA submission expected in Q2 2026.
• Completed patient enrollment in a global Phase III trial of AP301 across the U.S. and China, enrolling 282 CKD patients on maintenance dialysis with hyperphosphatemia.
• Alebund Pharmaceuticals is an integrated biopharmaceutical company focused on renal diseases and related chronic conditions.

Impact Therapeutics (7630.HK) Launches Hong Kong IPO to Raise Up to HK$ 910 Million

Key Words: Impact Therapeutics, IPO, HKEX, synthetic lethality, senaparib, PARP inhibitor, ovarian cancer, cornerstone investors

• The News: China-based Impact Therapeutics has commenced its initial public offering (IPO) on the Hong Kong Stock Exchange (HKEX), seeking to raise up to HK$ 901 million (US$ 115 million). The offering, scheduled to list on 13 May 2026, is jointly sponsored by Goldman Sachs and CICC. The company has secured a strong cornerstone investor lineup, including a US$ 10 million investment from existing shareholder Tencent, US$ 5 million from Lilly Asia Ventures, and US$ 5 million from Foresight Funds.
• Key Highlights:
• Deal Details:
  • IPO size: Approximately HK$ 910 million.
  • Listing Date: Expected to list on May 13, 2026.
• Drug Profile – Senaparib:
  • Senaparib: an oral PARP1/2 inhibitor approved in China for first-line maintenance treatment of ovarian cancer.
  • Approval was supported by the Phase III FLAMES study, which evaluated senaparib as first-line maintenance therapy in advanced ovarian cancer and met its primary endpoint.
  • Commercialized in China since January 2025.
• Impact Therapeutics is a China-based biopharmaceutical company focused on synthetic lethality-driven precision oncology, with a DDR pipeline led by the approved PARP1/2 inhibitor senaparib and additional WEE1, ATR and selective PARP1 programs.

GSK (GSK.L) Signs US$ 1 Billion Deal with SiranBio for ALK7-Targeting Oligonucleotide SA030

Key Words: GSK, SiranBio, ALK7, SA030, siRNA, metabolic disease, cardiovascular disease, abdominal fat, cardiometabolic disease

• The News: GSK has inked a global licensing agreement worth up to US$ 1 billion with SiranBio for SA030, excluding Greater China (mainland China, Hong Kong, Macau, and Taiwan). SA030 is a first-in-class, long-acting siRNA oligonucleotide targeting ALK7, with potential for reducing abdominal fat while preserving lean mass. Under the agreement, GSK will pay US$ 55 million upfront, potential milestone payments of up to US$ 1 billion, and tiered royalties on global net sales outside Greater China.
• Key Highlights:
• Deal Details:
  • Total deal value: Up to US$ 1 billion (including a US$ 55 million upfront payment).
  • Milestone payments: Performance-based payments tied to development, regulatory, and sales milestones.
  • Royalties: Tiered royalties on global net sales outside of Greater China.
  • GSK gains exclusive global rights outside Greater China, while SiranBio will complete Phase 1 clinical trials before transitioning development to GSK.
• Drug Profile: SA030
  • A first-in-class, long-acting siRNA oligonucleotide targeting ALK7, a protein associated with reducing abdominal fat while maintaining lean body mass.
  • Clinical stage: Currently in Phase 1 trials assessing tolerability and pharmacokinetics in overweight and obese patients.
  • Mechanism: Targeting ALK7 could potentially improve insulin sensitivity, blood lipid profiles, and reduce adipocyte-driven inflammation.
  • Platform Technology: Developed using SiranBio’s proprietary STORK-F adipose-targeted delivery platform, enabling targeted siRNA delivery to fat cells and sustained efficacy with a low-frequency dosing schedule.
• SiranBio is a Suzhou-based biotech focused on siRNA therapeutics, supported by proprietary delivery and dual-targeting RNA platforms.

Cabaletta Bio (CABA.O) Raises US$ 150 Million in Public Offering with Participation from Eli Lilly (LLY.N)

Key Words: Cabaletta Bio, Eli Lilly, public offering, rese-cel, CABA-201, CD19 CAR-T, autoimmune diseases, IASO Bio

• The News: Cabaletta Bio announced the pricing of an underwritten public offering of 51,725,000 shares of common stock at US$ 2.90 per share, raising approximately US$ 150 million in gross proceeds. The financing included participation from Bain Capital Life Sciences, Adage Capital Management, Cormorant Asset Management, Eli Lilly and Company. Proceeds will support the development of Cabaletta’s autoimmune cell therapy pipeline, led by rese-cel / CABA-201.
• Key Highlights:
• Deal Detail:
  • Total deal value: Approximately US$150 million.
  • 51,725,000 shares of common stock offered at US$ 2.90 per share.
• Drug Profile – Rese-cel / CABA-201:
  • Rese-cel / CABA-201: a 4-1BB-containing fully human CD19 CAR-T investigational therapy for autoimmune diseases.
  • Mechanism: Designed as a one-time cell therapy to deeply and transiently deplete CD19-positive B cells, aiming to reset the immune system.
• License Background: Obtained an exclusive worldwide license from a China based Biotech IASO Bio for a clinically validated fully human CD19 binder used in CABA-201.
• Cabaletta Bio is a late-stage clinical biotech company developing engineered T-cell therapies for autoimmune diseases, led by rese-cel, a fully human CD19 CAR-T designed to reset the immune system through deep B-cell depletion.

LTZ Therapeutics Raises US$ 38 Million to Advance U-MCE Immunotherapy Pipeline

Key Words: LTZ Therapeutics, financing, U-MCE, myeloid cell engager, LTZ-301, CD79b, immunotherapy, oncology, autoimmune diseases

• The News: LTZ Therapeutics announced the completion of an oversubscribed US$ 38 million financing round to accelerate development of its Universal Myeloid Cell Engager (U-MCE™)-based immunotherapy pipeline. The round was led by GL Ventures. Proceeds will support the ongoing Phase I study of LTZ-301, its lead asset for oncology and autoimmune diseases, as well as the IND filing and Phase I initiation of its second asset LTZ-232.
• Key Highlights:
• Deal Details:
  • Financing size: Up to US$ 38 million oversubscribed financing round led by GL Ventures.
  • Approximately US$ 130 million raised since founding in 2022.
• Lead Asset – LTZ-301:
  • LTZ-301 is a bispecific antibody designed to deplete CD79b-positive B cells by redirecting myeloid cells for autoimmune disease.
  • Clinical stage: currently in Phase I and actively enrolling patients at multiple U.S. clinical sites.
• Core Platform: U-MCE™ is LTZ’s Universal Myeloid Cell Engager platform, designed to harness monocytes and macrophages for immune-mediated disease clearance.
• LTZ Therapeutics is a clinical-stage immunotherapy biotech developing myeloid engager therapies for oncology and autoimmune diseases.

TenNor Therapeutics Passes HKEX Listing Hearing with Antibacterial and Microbiome-Metabolism Pipeline

Key Words: TenNor Therapeutics, IPO, HKEX, TNP-2198, TNP-2092, Helicobacter pylori, bacterial infection, microbiome metabolism

• The News: TenNor Therapeutics has passed the HKEX listing hearing and is preparing for a Hong Kong Main Board IPO, with CITIC Securities and ABC International as joint sponsors. Its pipeline includes seven innovative assets, led by rifasutenizol (TNP-2198) for pylori infection and rifaquizinone (TNP-2092) injection for implant-associated bacterial infections
• Key Highlights:
• Deal Details:
  • IPO Status: Passed the HKEX Main Board listing hearing with the joint sponsors of CITIC Securities and ABC International.
  • Recent Financing: Completed a RMB 300 million Series E financing in March 2025, reached a post-money valuation of RMB 2.013 billion.
• Core Product – Rifasutenizol:
  • Rifasutenizol: an NME candidate used as part of a triple therapy with amoxicillin and a PPI for pylori infection, and also as monotherapy for bacterial vaginosis and C. difficile infection.
  • Regulatory Status: Accepted by China’ s NMPA in August 2025, with approval expected by end-2026.
• Rifaquizinone as the second core asset is a triple-target candidate for implant-associated bacterial infections, including PJI, LVADI and CRBSI.
• TenNor Therapeutics is a near-commercial-stage biotech focused on bacterial infections and bacterial metabolism-related diseases to develop differentiated anti-infective therapies.

InxMed Licenses China Commercialization Rights of Two FAK Inhibitors to Fosun Pharma (2196.HK) in Deal Worth Over RMB 1.10 Billion

Key Words: InxMed, Fosun Pharma, IN10018, Ifebemtinib, IN10028, FAK inhibitor, commercialization rights, solid tumors

• The News: InxMed has entered a strategic collaboration with Fosun Pharma, granting Fosun exclusive sales, promotion and full-channel commercialization rights in mainland China for two internally developed FAK inhibitors, IN10018 (ifebemtinib) and IN10028. IN10018 is currently in Phase III clinical development in China, while IN10028 has received IND approval from China’s NMPA and is expected to enter Phase I clinical development
• Key Highlights:
• Deal Details:
  • Total Deal Value: Up to RMB 1.12 billion.
  • Upfront Payment: RMB 100 million.
  • Milestone Payments: Up to RMB 1.02 billion tied to R&D, regulatory progress and sales performance.
• Core Product – Ifebemtinib:
  • Ifebemtinib (IN10018): a small-molecule FAK inhibitor currently in Phase III clinical development in China.
  • Indication Focus: Platinum-resistant ovarian cancer, non-small cell lung cancer, pancreatic cancer and other solid tumors.
• Clinical Data: In recurrent ovarian cancer, IN10018 + PLD showed ORR of 40.7%, DCR of 81.5%, mPFS of 7.5 months and mOS of 20.2 months.
• Second Asset: IN10028 is a second-generation FAK inhibitor with NMPA IND approval and planned Phase I initiation.
• InxMed is a late-stage oncology biotech focused on overcoming tumor treatment resistance through FAK/integrin and tumor microenvironment biology.

UCB to Acquire Candid in US$ 2.2B Deal Centered on China-Originated Assets

Key Words: UCB, Candid Therapeutics, bispecific antibodies, autoimmune diseases, BCMA, China innovation

• The News: UCB, a global biopharmaceutical leader, announced it will acquire Candid Therapeutics, a clinical-stage biotech focused on T-cell engager therapies, in a deal worth US$ 2.2 billion. The agreement includes US$ 2 billion in upfront cash and US$ 200 million in potential milestone payments. The acquisition is expected to close by the end of the second quarter of 2026, pending regulatory approvals.
• Key Highlights:
• Deal Overview:
  • Transaction Value: US$ 2.2 billion, including US$2 billion upfront and US$200 million in milestones.
  • Adds four bispecific antibodies to UCB’s pipeline, particularly the flagship cizutamig and CND261, focusing on autoimmune diseases.
• Drug Profile – Cizutamig:
  • A BCMA-targeting T-cell engager designed to eliminate pathogenic B cells linked to autoimmune diseases.
  • Originates from China-based biotech I-Mab, demonstrating the growing global influence of Chinese R&D in biopharma innovation.
  • Originally developed for multiple myeloma, cizutamig was later re-positioned for autoimmune conditions. Over 100 clinical trials are ongoing for more than 10 autoimmune indications.
  • Engineered to reduce cytokine release syndrome (CRS) risk while maintaining strong therapeutic efficacy.
  • UCB sees this asset as a transformative, first-in-class therapy with the potential for worldwide leadership in autoimmune treatments.

Clinical

BrightGene Bio-Medical Technology (688166.SH) Reports Positive Phase III Results for GLP-1/GIP Dual Agonist BGM0504 in Weight Management

Key Words: BrightGene, BGM0504, GLP-1/GIP dual agonist, obesity, weight management, Phase III, cardiometabolic risk

• The News: BrightGene Bio-Medical Technology announced that its self-developed GLP-1/GIP receptor dual agonist BGM0504 injection met the primary endpoint and all key secondary endpoints in a Phase III weight management trial. The company plans to advance the NDA filing for BGM0504 injection in China for long-term weight management.
• Key Highlights:
• Clinical Data:
  • Phase III study conducted across 41 clinical centers in China, enrolling 652 non-diabetic overweight or obese adults.
  • Mean body weight reductions: 3%, 17.3% and 19.2% for the 5mg, 10mg and 15mg groups, vs. 3.1% for placebo at Week 52.
  • In the 15mg group, 67.3% of participants achieved ≥15% weight loss and 48.9% achieved ≥20% weight loss; waist circumference decreased by 16.5cm versus 3.3cm for placebo.
• Drug Profile – BGM0504:
  • BGM0504: a self-developed injectable GLP-1/GIP receptor dual agonist designed to activate downstream GLP-1 and GIP pathways.
  • Improved blood pressure, lipid parameters, uric acid and glycemic markers, with no hypotension events reported in the study.
  • Received an acceptance notice from China’ s NMPA.
• BrightGene Bio-Medical Technology specialized in metabolic and respiratory diseases, with its key value proposition centered on integrated R&D/manufacturing capabilities and a Phase III GLP-1/GIP dual agonist pipeline.

Innovent Biologics (1801.HK): IBI343 Becomes First CLDN18.2 ADC to Enter Priority Review, While Mazdutide Multi-dose Pen Gains NMPA Approval for Type 2 Diabetes

Key Words: Innovent Biologics, IBI343, CLDN18.2 ADC, exatecan, gastric cancer, GEJ adenocarcinoma, priority review, breakthrough therapy designation, mazdutide, Xinerpai, GCG/GLP-1 dual agonist, type 2 diabetes, multi-dose pen, NMPA

• The News: Innovent Biologics announced two regulatory milestones: IBI343 has been included in China CDE’s proposed Priority Review list for CLDN18.2-positive gastric / GEJ adenocarcinoma after at least two prior lines of therapy, becoming the first CLDN18.2 ADC to enter priority review; meanwhile, the pre-filled multi-dose pen formulation of mazdutide (Xinerpai®) has been approved by NMPA for adults with type 2 diabetes in China.
• Key Highlights:
• IBI343 — Clinical Data:
  • Study Design: Phase I, multicenter, open-label dose-escalation and dose-expansion study in advanced solid tumors and gastric / GEJ adenocarcinoma.
  • Efficacy: Achieved a confirmed ORR of 29.0%, DCR of 90.3% and median PFS of 5.5 months.
  • Safety: Showed a manageable safety profile, with minimal grade ≥3 gastrointestinal adverse events and no interstitial lung disease reported in the Phase I study.
• IBI343 — Drug Profile:
  • IBI343: A recombinant anti-CLDN18.2 monoclonal antibody–exatecan ADC.
  • Mechanism: Binds CLDN18.2-positive tumor cells, undergoes internalization, releases a TOPO1 inhibitor payload, induces DNA damage and supports bystander killing.
  • Proposed Indication: Locally advanced unresectable or metastatic CLDN18.2-positive gastric / GEJ adenocarcinoma after at least two prior systemic therapies.
• Mazdutide — Regulatory Milestone:
  • Approval: NMPA approved mazdutide’s pre-filled multi-dose injection pen in China.
  • Formulation: 2ml:24mg multi-dose pen covering 2mg / 4mg / 6mg dose titration in one device.
• Mazdutide — Clinical Data:
  • DREAMS-1: In 320 Chinese adults with T2D inadequately controlled by diet and exercise, once-weekly mazdutide 6mg reduced HbA1c by 2.15% at Week 24 vs. 0.14% for placebo.
  • DREAMS-2: In 731 Chinese adults with T2D on background oral anti-diabetic drugs, mazdutide 4mg and 6mg showed superiority to dulaglutide 1.5mg in HbA1c reduction at Week 28.
  • Weight Benefit: Achieved greater body-weight reduction than dulaglutide, with LS mean treatment differences of –3.78% for 4mg and –5.76% for 6mg.
• Mazdutide — Drug Profile:
  • QLS1304 (Mazdutide): A once-weekly GCG/GLP-1 dual receptor agonist.
  • Mechanism: GLP-1 receptor activation supports glucose control and weight reduction, while GCG receptor activation may increase energy expenditure and improve hepatic fat metabolism.

Qilu Pharmaceutical Presents First-in-Human Phase Ia Data for KAT6A/6B Inhibitor QLS1304 at ESMO Breast Cancer 2026

Key Words: Qilu Pharmaceutical, QLS1304, KAT6A/6B inhibitor, ESMO Breast Cancer 2026, Phase Ia, ER+/HER2- breast cancer, advanced solid tumors

• The News: Qilu Pharmaceutical presented first-in-human Phase Ia clinical data for QLS1304, a highly selective KAT6A/6B inhibitor, at the 2026 ESMO Breast Cancer Annual Meeting. The dose-escalation study enrolled 18 patients with advanced solid tumors, including ER+/HER2- breast cancer, TNBC and CRPC, who had failed prior standard therapies. QLS1304 showed no DLTs and MTD was not reached, with preliminary antitumor activity observed in ER+/HER2- breast cancer patients.
• Key Highlights:
• Clinical Data:
  • Study Design: First-in-human Phase Ia study of QLS1304 monotherapy in 18 patients with advanced solid tumors after prior standard therapy failure.
  • Efficacy: Two patients in the 8mg dose group achieved partial response; ORR was 18.2% in ER+/HER2- breast cancer and 40.0% at the 8mg dose level.
  • Safety: Grade ≥3 TRAEs occurred in 55.6% of patients, with anemia and neutropenia among common events.
• Drug Profile – QLS1304:
  • QLS1304: A novel small-molecule epigenetic oral drug and a highly selective dual KAT6A/6B inhibitor.
  • Mechanism: It inhibits KAT6A and KAT6B, lysine acetyltransferases involved in histone acetylation, ER signaling and tumor cell proliferation.
  • Indication: Focued on advanced ER+/HER2- breast cancer, with early testing also including other advanced solid tumors such as TNBC and CRPC.
• Qilu Pharmaceutical is a leading vertically integrated pharmaceutical company with broad API, formulation and innovative drug capabilities across oncology, cardiovascular, anti-infective, CNS and other therapeutic areas.

HEC Pharm’s (6887.HK) HEC-648 Becomes China’s First Nipah Virus mAb to Enter Clinical Development

Key Words: HEC Pharm, HEC-648, Nipah virus, monoclonal antibody, G protein, Phase I, public health emergency

• The News: HEC Pharm announced that its Class 1 new drug HEC-648 injection has been approved by China’s NMPA to enter clinical trials for the treatment of Nipah virus infection. Co-developed with the Wuhan Institute of Virology, Chinese Academy of Sciences, HEC-648 is a fully human neutralizing monoclonal antibody targeting the Nipah virus G protein. The candidate is intended to address the lack of approved targeted therapies for Nipah virus infection.
• Key Highlights:
• Clinical Data:
  • Clinical tiral approval: HEC-648 injection received NMPA approval to initiate clinical trials for Nipah virus infection
  • Study design: The Phase I trial will be randomized, double-blind, placebo-controlled and dose-escalating, evaluating single and multiple doses in healthy participants.
  • The trial will assess safety, tolerability, pharmacokinetics and immunogenicity, with clinical work expected to advance in 2026.
• Drug Profile – HEC-648:
  • HEC-648: A fully human neutralizing monoclonal antibody targeting the Nipah virus G protein.
  • Mechanism: It binds the viral G protein with high specificity and affinity, competitively blocking viral attachment to host-cell receptors and preventing cell entry.
  • Preclinical Data: In animal models, HEC-648 showed 100% preventive mortality protection and over 80% therapeutic mortality protection.
• HEC Pharm is an integrated vertical pharmaceutical company focused on innovative drugs, generics and biosimilars across infectious diseases, chronic diseases and oncology.

Jiangsu Lianhuan’s (600513.SH) LH-1801 Meets Phase III Endpoints in Type 2 Diabetes

Key Words: Jiangsu Lianhuan Pharmaceutical, LH-1801, SGLT-2 inhibitor, Type 2 diabetes, Phase III, HbA1c, metformin

• The News: Jiangsu Lianhuan Pharmaceutical announced positive topline results from the Phase III clinical program of LH-1801, a novel SGLT-2 inhibitor for type 2 diabetes. In the Phase III monotherapy trial, LH-1801 20mg and 40mg significantly reduced HbA1c versus placebo at Week 24. A separate Phase III combination trial of LH-1801 plus metformin also met its primary endpoint, showing non-inferiority to dapagliflozin plus metformin. The company plans to submit new drug registration materials for LH-1801
• Key Highlights:
• Clinical Data:
  • Study design: Phase III monotherapy trial in 402 patients with type 2 diabetes, evaluating LH-1801 20mg and 40mg vs. placebo over 24 weeks.
  • HbA1c reduction: At Week 24, least-squares mean HbA1c changes from baseline were -0.93% for 20mg and -0.97% for 40mg, v -0.20% for placebo.
  • Combination trial: LH-1801 plus metformin also met the primary endpoint and showed non-inferiority to dapagliflozin plus metformin.
• Drug Profile – LH-1801:
  • LH-1801: A novel small-molecule SGLT-2 inhibitor for type 2 diabetes.
  • Mechanism: SGLT-2 inhibition lowers blood glucose by reducing renal glucose reabsorption and increasing urinary glucose excretion.
  • Planned to submit new drug registration data, while approval timing and commercialization remain subject to regulatory review.
• Jiangsu Lianhuan Pharmaceutical is a Yangzhou-based pharmaceutical manufacturer with products spanning APIs, generics and innovative drugs across diabetes, cardiovascular, urinary, anti-infective and other therapeutic areas.

InnoCare’s (688428.SH) ICP-488 Cleared for Phase II Trial in Sjögren’s Syndrome

Key Words: InnoCare, ICP-488, TYK2 inhibitor, Sjögren’s syndrome, autoimmune disease, Phase II, CDE

• The News: InnoCare announced that China’s CDE has approved a Phase II clinical trial of ICP-488 for Sjögren’s syndrome. ICP-488 is an oral, selective TYK2 allosteric inhibitor that binds the TYK2 JH2 domain and blocks signaling of IL-23, IL-12, type I IFN and other inflammatory cytokines. The program targets a high-unmet-need autoimmune disease, as there are currently no globally approved targeted therapies for Sjögren’s syndrome.
• Key Highlights:
• Clinical Trial Approval: ICP-488 received CDE approval to enter Phase II clinical development for Sjögren’s syndrome in China.
• Sjögren’s syndrome is a chronic inflammatory autoimmune disease involving salivary and lacrimal gland dysfunction, with possible multi-organ involvement.
• China’s prevalence is estimated at 0.33%-77%, representing around 5 million patients, with no approved targeted therapy globally.
• Drug Profile – ICP-488:
  • ICP-488: An oral, potent and highly selective TYK2 allosteric inhibitor.
  • Mechanism: It binds the TYK2 JH2 domain and blocks IL-23, IL-12 and type I IFN signaling, aiming to suppress autoimmune and inflammatory disease processes.
  • Developed across autoimmune diseases, including Sjögren’s syndrome, cutaneous lupus erythematosus and psoriasis.
• InnoCare is a commercial-stage biopharma company developing and commercializing first- and best-in-class therapies for cancer and autoimmune diseases, supported by an integrated R&D, manufacturing and commercialization platform.

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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