This week, biotech saw Insilico’s $2.5B SK deal, Abbisko’s $1.9B Lilly partnership, TrueLab’s $985M license, CARsgen’s CAR-T, and Biokin’s bispecific ADC approvals. Key moves spanned CNS, autoimmune, oncology, and gene editing.

Transactions & BD (In/Out Licensing)

Insilico Medicine (3696.HK) Partners with SK Biopharmaceuticals in Neuroimmune Drug Discovery Deal Worth Over US$ 2.5 Billion

Key Words: Insilico Medicine, SK Biopharmaceuticals, AI drug discovery, neuroimmune disorders, CNS, generative AI, Pharma.AI, small molecules

• The News: Insilico Medicine entered into a research and development collaboration with SK Biopharmaceuticals to discover and advance AI-enabled drug candidates for neuroimmune disorders affecting the central nervous system. The partnership, announced at the BIO 2026 International Convention, carries a total potential value exceeding US$ 2.5 billion.
• Key Highlights:
• Deal Details:
  • Upfront and Near-term Payments: up to US$18 million.
  • Total Potential Value: more than US$5 billion, including development, regulatory and commercial milestone payments.
• Platform Profile – Pharm.AI:
  • AI: a AI-driven drug discovery platform integrating target identification and validation, generative chemistry and molecular optimization.
  • Track Record: since 2021, Insilico has nominated 31 preclinical candidates, of which 13 have received IND approval or clearance.
  • Development Efficiency:reports reaching preclinical candidate nomination in approximately 12-18 months on average, compared with the conventional 2.5-4-year early discovery timeline.
  • Therapeutic Focus: neuroimmune disorders, focusing on diseases involving dysregulated interactions between the nervous and immune systems, including neuroinflammatory, neurodegenerative and rare neurological disorders.
• SK Biopharmaceuticals is a South Korea-based CNS-focused biopharmaceutical company with integrated global development and commercialization capabilities, led by its epilepsy therapy cenobamate.

Abbisko Therapeutics (2256.HK) Partners with Eli Lilly (LLY.N) in Multi-Target Drug Discovery Deal Worth Up to US$ 1.9 Billion

Key Words: Abbisko Therapeutics, Eli Lilly, drug discovery, multi-target collaboration, small molecules, oncology, licensing agreement

• The News: Abbisko Therapeutics entered into a strategic research collaboration and licensing agreement with Eli Lilly to discover and develop innovative medicines against multiple Lilly-selected disease targets. Abbisko will lead discovery and early-stage development activities and is eligible to receive up to approximately US$ 1.9 billion.
• Key Highlights:
• Abbisko and Lilly previously entered into a global collaboration and exclusive licensing agreement in 2022 for the discovery and development of a novel small-molecule therapy.
• Deal Details:
  • Total Deal Value: up to approximately US$9 billion.
  • Discovery and early development of novel drug candidates across multiple disease targets selected by Lilly.
• Platform Profile – Early-Stage Drug Discovery Platform:
  • Abbisko will leverage its integrated drug discovery platform, medicinal chemistry capabilities and translational development expertise to identify and optimize novel therapeutic candidates.
  • Designed to generate multiple globally competitive programs rather than a single asset.
  • Focused on precision oncology and immuno-oncology, supported by small-molecule discovery and early clinical development capabilities.

TrueLab Biopharmaceutical Licenses TL1A Antibody Programs to Bionyra Pharma in Deal Worth Up to US$ 985 Million

Key Words: TrueLab Biopharmaceutical, Bionyra Pharma, TL-001, TL-003, TL1A, IL-23p19, inflammatory bowel disease, bispecific antibody, licensing agreement

• The News: TrueLab Biopharmaceutical entered into an exclusive licensing agreement with Bionyra Pharma for TL-001, an anti-TL1A monoclonal antibody, and TL-003, a TL1A × IL-23p19 bispecific antibody. TrueLab is eligible to receive up to US$ 985 million in upfront and milestone payments, tiered royalties and a single-digit equity stake in Bionyra following completion of its Series A financing.
• Key Highlights:
• Deal Details:
  • Total Deal Value: up to US$985 million, including upfront, development, regulatory and commercial milestone payments.
  • Equity Component: TrueLab will receive a single-digit equity stake in Bionyra following completion of its Series A financing.
  • Financing: Bionyra completed a US$165 million Series A financing co-led by Jeito Capital and Sofinnova Partners.
• Product Profile – TL-001 / BYN-002
  • TL-001: an extended-half-life humanized IgG1 monoclonal antibody targeting TL1A.
  • Mechanism:blocked the interaction between TL1A and its receptor DR3, suppressing downstream inflammatory and fibrotic signaling involved in chronic intestinal inflammation.
  • Indication Focus: inflammatory bowel disease and other TL1A-driven immune-mediated inflammatory diseases.
  • Designed to generate multiple globally competitive programs rather than a single asset.
  • Development Stage: Phase I enrollment has been completed in Australia, including single-ascending-dose and multiple-ascending-dose cohorts.
• Product Profile – TL-003 / BYN-003:
  • TL-003: an extended-half-life bispecific antibody designed to bind TL1A and IL-23p19 with high affinity, either independently or simultaneously.
  • Mechanism: by simultaneously blocking TL1A-mediated inflammatory and fibrotic signaling and IL-23-driven immune activation, TL-003 is designed to provide broader and more durable disease control than single-pathway inhibition.
  • Indication Focus: inflammatory bowel disease and other immune-mediated inflammatory diseases involving TL1A and IL-23 signaling.
  • Development Stage: Phase I clinical development is underway in Australia, with enrollment initiated in 2026.
• TrueLab Biopharmaceutical is an immunology-focused biotech developing monoclonal, bispecific and multispecific antibodies for immune-mediated inflammatory diseases.
• Bionyra Pharma is a newly launched clinical-stage biotech focused on next-generation biologics for severe inflammatory diseases, initially targeting inflammatory bowel disease and atopic dermatitis.

Huajian Future (6132.HK) Lists on HKEX With HK$ 1.1 Billion IPO and 1,166x Over-subscription

Key Words: IPO, Huajian Future, TYK2 inhibitor, GLP-1, KRAS G12C, topical therapy, oral small molecule

• The News: Huajian Future debuted on the Hong Kong Stock Exchange on June 23 after raising approximately HK$ 1.11 billion from a global offering of 13.6 million H-shares at HK$ 81.80 per share, with a post-IPO market cap of about HK$ 6.02 billion. The IPO attracted HK$ 129.8 billion in margin subscriptions, representing a 1,166x oversubscription, and six cornerstone investors including Ruiyuan Fund, Kaibo Private Equity, Clearwater Capital, Sage Partners, Panjing Fund, and Taikang Life Insurance committed US$ 65 million, or 45.7% of the offering.
• Key Highlights:
• Deal Details:
  • Total Deal Value: HK$ 1.11 billion gross proceeds from the IPO, with a post-IPO market cap of approximately HK$ 6.02 billion.
  • Cornerstone Investment: six institutional investors subscribed US$ 65 million, representing 45.7% of the global offering.
  • Pre-IPO Financing: China Development Bank Shanghai (approx. 9.2% stake), Legend Capital (approx. 7.08%), and Junshi Biosciences (approx. 2.1%) invested a cumulative RMB$ 619 million over eight years, valuing the company at RMB$ 2.7 billion.
• Product Profile – HJ787:
  • HJ787: a topical selective TYK2 inhibitorfor mild-to-moderate atopic dermatitis (AD), neurodermatitis (ND), and acne vulgaris (AV).
  • Mechanism: targets intracellular TYK2 kinase to inhibit IL-12, IL-23, and type I interferon signaling, with optimized physicochemical properties for dermal penetration and low percutaneous absorption.
  • Clinical Data: in a Phase 2 AD trial, EASI-75 rates were 25.0% (0.5% QD), 30.0% (3% QD), and 62.5% (3% BID); all treatment-related adverse events were mild, with no serious adverse events leading to discontinuation.
  • Development Status: Phase 2 AD completion expected by September 2026, with Phase 3 initiation in H2 2026; Phase 2b for AV and Phase 3 for ND planned for H1 2027.

Haisco (002653.SZ) Out-Licenses Two Small Molecule Drugs to Nuvectis Pharma (NVCT.O) for Up to US$ 1.461 Billion

Key Words: Haisco, Nuvectis Pharma, out-license, small molecule, B factor inhibitor, BRAF inhibitor, PNH, IgAN, oncology

• The News: Haisco Pharmaceutical granted Nuvectis Pharma exclusive rights outside China for two clinical-stage small molecule candidates, NXP100 and NXP200, in a deal valued at up to US$ 1.461 billion. The transaction expands Nuvectis’ pipeline into complement-mediated diseases and oncology, leveraging Haisco’s recent track record of licensing to Eli Lilly (LLY.N) and AbbVie (ABBV.N).
• Key Highlights:
• Deal Details:
  • Total Deal Value: up to US$ 1.461 billion, including upfront and milestone payments.
• Product Profile – NXP100 (HSK39297):
  • NXP100: an oral, once-daily complement factor B inhibitor for complement-mediated diseases.
  • Mechanism: prevented formation and amplification of the alternative-pathway C3 convertase and reducing downstream complement activation, hemolysis and complement-mediated tissue injury.
  • Indication Focus: paroxysmal nocturnal hemoglobinuria (PNH) and IgA nephropathy (IgAN).
  • Development Stage: two New Drug Applications (NDAs) submitted to China’s NMPA for PNH, based on positive Phase 3 data; Phase 3 trial ongoing in IgAN.
• Product Profile – NXP200 (HSK42360):
  • NXP200: a next-generation BRAF inhibitor designed to overcome resistance to first-generation agents.
  • Mechanism: inhibited MAPK signaling driven by BRAF V600 and Class II/III non-V600 alterations, minimizing paradoxical activation of wild-type RAF dimers associated with earlier-generation BRAF inhibitors.
  • Indication Focus: oncology, specifically BRAF-mutant tumors.

Micot Pharma (2335.HK) Opens Over 80% on Debut as First Hong Kong 18A Peptide Company

Key Words: Micot Pharma, Hong Kong 18A, peptide, IPO, MT1013, XTL6001, Everest Medicines

• The News: Micot Pharma, a Xi’an-based biotech focused on dual/multi-specific peptide drugs, listed on the Hong Kong Stock Exchange under 18A rules at HK$ 18.20 per share, raising HK$ 1.056 billion. The stock opened at HK$ 34.02, up 87%, giving the company a market cap of approximately HK$ 11 billion.
• Key Highlights:
• Deal Details:
  • IPO raised HK$ 1.056 billion from 58.05 million global shares, with 39.1% of proceeds allocated to lead product MT1013 clinical trials and commercial launch.
  • Three cornerstone investors subscribed for HK$ 449 million: Qiyuan Hong Kong (HK$ 341 million, backed by Shaanxi government funds), Everest Medicines (HK$ 100 million), and Shunming Capital (HK$ 7.83 million).
  • Everest Medicines (1952.HK) previously signed an exclusive commercialization deal for MT1013 in China and Asia-Pacific (ex-Japan) with up to RMB$ 1.24 billion in upfront and milestones, including RMB$ 200 million upfront already received.
• Product Profile – MT1013:
  • MT1013: a Phase III dual-target receptor agonist peptide targeting CaSR and OGP receptors for chronic kidney disease secondary hyperparathyroidism.
  • Mechanism: activated CaSR to suppress excessive parathyroid hormone secretion and improve calcium–phosphate homeostasis.
  • Phase II data showed iPTH, serum calcium, and phosphorus composite control rate approximately 2.5x that of standard-of-care etelcalcetide, with significantly reduced FGF23 levels linked to cardiovascular risk.
  • Phase III trial fully enrolled 424 patients; NDA submission expected by end-2027, commercialization by early 2028.

RTW (RTW.L) and RA Capital Lead US$ 230 Million Newco Round for Serapha Bio with Core Asset from YolTech Therapeutics

Key Words: gene editing, base editing, AATD, Serapha Bio, YolTech Therapeutics, RA Capital, RTW Investments

• The News: Serapha Bio signed a merger agreement with Nasdaq-listed Boundless Bio and closed a US$ 230 million private financing led by RA Capital Management and RTW Investments. The funds will support Serapha’s lead asset SERP-01 through Phase II and into Phase III trials for alpha-1 antitrypsin deficiency.
• Key Highlights:
• Deal Details:
  • Total financing of US$ 230 million, with approximately US$ 138 million from a Series A and the remaining US$ 92 million closing concurrently with the merger.
  • Serapha obtained ex-Greater China rights to SERP-01 from YolTech Therapeutics in June 2026, with YolTech receiving an upfront payment, equity, and eligibility for over US$ 2 billion in regulatory and commercial milestones plus tiered royalties on net sales.
• Product Profile – SERP-01:
  • SERP-01: an in vivo base editing therapy for AATD, designed to restore alpha-1 antitrypsin to normal physiological levels in severe patients.
  • Mechanism: an in vivo base-editing therapy designed to correct the SERPINA1 E342K mutation, restore functional AAT production and reduce toxic Z-AAT accumulation in the liver.
  • Indication Focus: severe PiZZ alpha-1 antitrypsin deficiency, targeting both lung and liver manifestations.
  • Development Stage: YolTech has initiated an investigator-initiated trial (IIT) at Shanghai Renji Hospital; Serapha plans to complete Phase II and start Phase III with the new funding.
• YolTech Therapeutics: a China-based biotechnology company focused on developing in vivo gene editing therapies using its proprietary base editing platform.

Oblenio Bio, a NewCo Founded by Weilizhibo (9887.HK) and Aditum Bio, Closes US$ 62 Million Series B Round Led by Pfizer Ventures (PFE.N)

Key Words: Oblenio Bio, Weilizhibo, Aditum Bio, Pfizer Ventures, LBL-051, CD19, BCMA, CD3, trispecific T cell engager, autoimmune disease, Series B

• The News: Oblenio Bio, an autoimmune-focused NewCo co-founded by Weilizhibo and Aditum Bio, closed an oversubscribed US$ 62 million Series B round led by Pfizer Ventures with participation from Deep Track Capital, GV, and Aditum Bio. Proceeds will fund clinical development of LBL-051, a CD19×BCMA×CD3 trispecific T cell engager designed to reset the immune system in severe autoimmune diseases.
• Key Highlights:
• Deal Details:
  • Total Deal Value: US$ 62 million Series B round, oversubscribed.
  • Lead Investor: Pfizer Ventures; participants include Deep Track Capital, GV, and founding investor Aditum Bio.
• Product Profile – LBL-051:
  • LBL-051: a trispecific T cell engager targeting CD19, BCMA, and CD3 for immune reset in severe autoimmune diseases.
  • Mechanism: designed to broadly deplete pathogenic B cells and plasma cells, potentially enabling deeper and more durable responses versus mono- or bispecific antibodies.
  • Preclinical Data: in non-human primates, step-dose administration achieved complete peripheral and tissue B cell and plasma cell depletion, with recovery of immature non-memory B cells; no cytokine release syndrome observed even at high exposures; dose-dependent immunoglobulin decline consistent with plasma cell clearance.
  • Development Stage: rapidly advancing toward clinical trials.
• Oblenio Bio: a US-based autoimmune disease company co-founded by Weilizhibo and Aditum Bio, focused on developing LBL-051, a trispecific T cell engager for immune reset.

EpimAb Biotherapeutics Refiles for Hong Kong IPO With Over US$ 2.1 Billion in BD Deals

Key Words: EpimAb Biotherapeutics, Hong Kong IPO, bispecific antibody, T-cell engager, autoimmune, oncology, platform technology

• The News: EpimAb Biotherapeutics, a Shanghai-based bispecific antibody company, refiled its IPO application on the Hong Kong Stock Exchange under Chapter 18A on June 24, 2026, with CITIC Securities and CMB International as joint sponsors. The company has accumulated over US$ 2.1 billion in total BD deal value, including a US$ 635 million global license for EMB-06 to Candid Therapeutics in 2024.
• Key Highlights:
• Total BD deal value exceeds US$ 2.1 billion, with the EMB-06 license to Candid (ex-China autoimmune rights) contributing US$ 635 million in potential milestones.
• Product Profile – EMB-01:
  • EMB-01: a FIT-Ig-derived EGFR/cMET bispecific antibody in Phase II for third-line colorectal cancer, with first patient dosed in December 2025 and primary endpoint expected by December 2027.
  • Mechanism: dual blockade of EGFR and cMET pathways to overcome resistance to single-target EGFR therapies.
  • Indication Focus: colorectal cancer, with a Phase Ib combination with chemotherapy in second/third-line setting approved by China’s NMPA, expected to start in Q3 2026.
• Product Profile – EMB-06:
  • EMB-06: a FIT-Ig-derived BCMA/CD3 bispecific antibody, initially developed for multiple myeloma, now pivoted to autoimmune indications via the Candid deal.
  • Mechanism: T-cell engager targeting BCMA to deplete pathogenic B cells in autoimmune diseases.
  • Indication Focus: autoimmune diseases (ex-China rights licensed to Candid) and multiple myeloma (China rights retained).
• EpimAb Biotherapeutics: a clinical-stage biotech focused on internally discovered bispecific antibodies for oncology and autoimmune diseases, built on four proprietary platforms.

Antengene (6996.HK) Out-Licenses Two TCE Assets for Nearly US$ 2 Billion

Key Words: Antengene, K2 Therapeutics, TCE, ATG-106, CDH6, CD3, AnTenGager, out-license, bispecific, oncology

• Key Highlights:
• Deal Details:
  • Total Deal Value: up to US$ 1.961 billion across both programs.
  • ATG-106 Upfront: ~US$ 20 million in cash and minority equity in a new K2 subsidiary.
  • ATG-106 Milestones: up to US$ 960.5 million plus tiered sales royalties.
  • Option Deal Terms: ~US$ 20 million in option fee, exercise fee and near-term payments; up to US$ 960.5 million in milestones if exercised; additional sales royalties.
• Product Profile – ATG-106:
  • ATG-106: a preclinical CDH6×CD3 bispecific T cell engager developed on Antengene’s AnTenGager® platform for solid tumors.
  • Mechanism: uses steric-hindrance masking of the CD3-binding arm until target antigen engagement, combined with a “fast-on/fast-off” CD3 binder to reduce cytokine release syndrome and T cell exhaustion.
  • Indication Focus: solid tumors expressing CDH6.
• Platform Profile – AnTenGager®:
  • AnTenGager®: Antengene’s proprietary TCE platform designed to improve safety and tolerability in solid tumors via disease-associated antigen-gated T cell activation.
  • Key Feature: spatial masking of CD3 binding arm in the absence of target antigen, enabling potent activity with reduced off-tumor toxicity.

Lynk Pharma Files for a Hong Kong IPO Targeting Autoimmune and Inflammatory Diseases with Small Molecule Drugs

Key Words: Lynk Pharma, IPO, autoimmune, JAK inhibitor, LNK01001, LNK01004, Hong Kong

• The News: Lynk Pharma, a clinical-stage biotech focused on autoimmune and inflammatory small molecule drugs, filed for a Hong Kong IPO after generating its first revenue in Q1 2026 from a licensing deal. The company’s lead asset LNK01001, an oral JAK1 selective inhibitor, completed a Phase III trial in atopic dermatitis and was submitted for marketing approval in April 2026, with potential approval expected in H2 2027.
• Key Highlights:
• Deal Details:
  • Total Deal Value:revenue of RMB$ 38.6 million in Q1 2026 came entirely from a December 2025 out-licensing deal with Bleecker Bio for global rights (ex-China) to LNK01006, including a US$ 5 million upfront payment.
  • IPO Proceeds Allocation: 70% for clinical development and commercialization of LNK01001 and LNK01004, 15% for other pipeline assets, 10% for R&D facility upgrades, and 5% for working capital.
  • Financial Profile: net loss narrowed 34.8% from RMB$ 312 million in 2024 to RMB$ 203 million in 2025; Q1 2026 net profit of RMB$ 2.5 million; cash and equivalents of RMB$ 144 million plus RMB$ 50 million in time deposits as of March 2026.
• Product Profile – LNK01001:
  • LNK01001: an oral second-generation JAK1 selective inhibitor for autoimmune diseases, with a completed Phase III trial in atopic dermatitis and a marketing application submitted in April 2026.
  • Mechanism: inhibited JAK1-dependent signaling downstream of multiple pro-inflammatory cytokines reducing immune-cell activation and inflammatory responses.
  • Indication Focus: atopic dermatitis, rheumatoid arthritis, ankylosing spondylitis, and vitiligo.
  • Development Stage: Phase III completed for atopic dermatitis; additional indications in earlier stages.
• Product Profile – LNK01004:
  • LNK01004: a topical soft pan-JAK inhibitor for inflammatory skin conditions, with a completed Phase II trial in atopic dermatitis.
  • Mechanism:inhibited JAK-mediated inflammatory signaling within the skin, while its topical soft-drug design is intended to provide local activity with rapid systemic inactivation and low systemic exposure.
  • Indication Focus: atopic dermatitis, chronic hand eczema, and vitiligo.
  • Development Stage: Phase II completed; Phase III planned for H1 2027.
• Lynk Pharma: a China-based biotech founded in 2017, developing small molecule drugs for autoimmune and inflammatory diseases, with two core clinical-stage assets and seven preclinical candidates.

Sinovent Passes Its Shanghai STAR Market IPO Review

Key Words: Sinovent, IPO, STAR Market, oncology, anti-infectives

• The News: Sinovent, a clinical-stage biotech focused on oncology and anti-infectives, received approval from the Shanghai Stock Exchange for its STAR Market IPO under the fifth-set listing standards. The company, which has no marketed products, reported a net profit of RMB$ 203 million in 2025, driven primarily by a one-time asset disposal gain, and plans to raise up to RMB$ 2.94 billion for R&D and working capital.
• Key Highlights:
• Deal Details:
  • IPO Status: passed the Shanghai STAR Market listing review on June 26, 2026, under the fifth-set standards requiring a minimum expected market cap of RMB$ 4 billion and at least one Phase II-ready core product.
  • Financing History: raised over RMB$ 2 billion since its 2017 founding; post-money valuation in its February 2024 Series E round was RMB$ 5.462 billion.
  • IPO Proceeds: plans to raise up to RMB$ 2.94 billion, with RMB$ 2.34 billion allocated to new drug R&D projects and RMB$ 600 million for working capital.
  • Financial Profile: reported zero revenue in 2023 and 2024, then RMB$ 935 million in 2025 revenue; accumulated losses of RMB$ 1.449 billion as of end-2025; R&D expenses totaled RMB$ 1.26 billion over three years.
• Sinovent: a China-based clinical-stage biotech developing novel therapies for oncology and anti-infectives, with a pipeline including one NDA-stage asset, three Phase III candidates, and multiple earlier-stage programs.

Clinical

CARsgen’s (2171.HK) Satri-cel Becomes World’s First Approved CAR-T Therapy for Solid Tumors

Key Words: CARsgen, satri-cel, Claudin18.2, CAR-T, gastric cancer, gastroesophageal junction cancer, NMPA approval, solid tumors

• The News: CARsgen Therapeutics’ satricabtagene autoleucel, or satri-cel, received NMPA approval for Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines of therapy. The approval makes satri-cel the world’s first approved CAR-T therapy for a solid tumor.
• Key Highlights:
• Regulatory Status:
  • Approved Indication: c2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy.
  • Regulatory Authority: China NMPA.
• Drug Profile – Satri-cel:
  • Satri-cel: an autologous, humanized Claudin18.2-targeted CAR-T therapy developed by CARsgen for Claudin18.2-positive solid tumors.
  • Mechanism: patient T cells are genetically engineered to express a CAR recognizing Claudin18.2, enabling selective targeting and destruction of Claudin18.2-expressing tumor cells.
  • CAR Design: incorporated a humanized Claudin18.2-specific binding domain, CD8α hinge, CD28 transmembrane and costimulatory domains, and a CD3ζ signaling domain.
  • Indication Focus: advanced gastric and gastroesophageal junction cancer, with further development in pancreatic cancer, biliary tract cancer and earlier-line or perioperative gastric cancer settings.
  • Target selection: Claudin18.2 has limited expression in normal tissues but is highly expressed in several gastrointestinal tumors, supporting selective tumor targeting.

Biokin’s (688506.SH) Iza-bren Becomes World’s First Approved Bispecific ADC

Key Words: Biokin, SystImmune, iza-bren, BL-B01D1, EGFR×HER3, bispecific ADC, nasopharyngeal carcinoma, NMPA approval

• The News: Biokin received NMPA approval for iza-bren / BL-B01D1 for recurrent or metastatic nasopharyngeal carcinoma following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. The approval marks the first regulatory approval for iza-bren and the first approval of a bispecific antibody-drug conjugate globally.
• Key Highlights:
• Regulatory Status:
  • Approved Indication: recurrent or metastatic nasopharyngeal carcinoma after progression on prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy.
  • Regulatory Authority: China NMPA.
  • First approved EGFR×HER3 bispecific ADC and first approved bispecific ADC globally.
• Clinical Data:
  • Study Design: Phase III, randomized, open-label BL-B01D1-303 study comparing iza-bren with physician’s choice of chemotherapy.
  • Patient Population: recurrent or metastatic NPC after prior PD-1/PD-L1 therapy and at least two lines of chemotherapy, including one platinum-containing regimen.
  • Response: BICR-confirmed ORR was 54.6% with iza-bren versus 27.0% with chemotherapy.
  • Response Durability: median DoR was 8.5 months versus 4.8 months, with HR of 0.43.
  • PFS: median PFS was 8.38 months versus 4.34 months, with HR of 0.44.
• Drug Profile – Iza-bren / BL-B01D1:
  • Iza-bren: a first-in-class EGFR×HER3 bispecific ADC developed by Biokin and SystImmune for epithelial tumors expressing EGFR and HER3.
  • Mechanism: the bispecific antibody simultaneously binds EGFR and HER3, suppressing tumor growth and survival signaling while promoting ADC internalization.
  • Indication Focus: approved for later-line recurrent or metastatic nasopharyngeal carcinoma, with broader development across EGFR- and HER3-expressing solid tumors.

CMS’s (867.HK) Silevimig Becomes World’s First Approved Bispecific Antibody for Rabies Post-Exposure Prophylaxis

Key Words: China Medical System, CMS, silevimig, GR1801, rabies, bispecific antibody, passive immunization, NMPA approval

• The News: China Medical System Holdings’ silevimig injection received NMPA approval for passive immunization in adults following rabies virus exposure. Silevimig is the world’s first fully human bispecific antibody targeting two epitopes of the rabies virus and provides immediate protection before vaccine-induced immunity is established.
• Key Highlights:
• Regulatory Status:
  • Approved Indication: passive immunization in adults following rabies virus exposure..
  • Regulatory Authority: China NMPA.
  • First approved fully human bispecific antibody targeting dual rabies virus epitopes.
• Clinical Data:
  • In a Phase III adult study, silevimig met its primary endpoint and demonstrated non-inferior protective efficacy versus human rabies immune globulin.
  • The study showed that silevimig provided immediate early protection without compromising the active immune response induced by rabies vaccination.
  • A Phase III study in children and adolescents aged 2 to under 18 years is ongoing in China.
• Drug Profile – Silevimig / GR1801:
  • Silevimig: A recombinant fully human bispecific antibody developed for rabies post-exposure passive immunization.
  • Mechanism: silevimig binds epitopes I and III on the rabies virus glycoprotein, blocking viral interaction with host-cell receptors and neutralizing the virus before vaccine-induced antibodies reach protective levels.
  • Indication Focus: post-exposure prophylaxis for adults requiring passive immunization, particularly Category III exposure and selected immunocompromised Category II cases.

RemeGen’s (9995.HK / 688331.SH) Telitacicept Becomes First Approved Biologic for Primary Sjögren’s Syndrome

Key Words: RemeGen, telitacicept, RC18, BLyS, APRIL, primary Sjögren’s syndrome, IgA nephropathy, autoimmune disease, NMPA approval

• The News: RemeGen’s telitacicept received NMPA approval for two new indications: primary Sjögren’s syndrome and primary IgA nephropathy. With the approval, telitacicept becomes the first biologic approved globally for Sjögren’s syndrome, expanding its approved China indications to five.
• Key Highlights:
• Clinical Data:
  • Primary Sjögren’s syndrome: In a Phase III study, telitacicept met the primary endpoint, with disease activity score reduced by 4.4 points versus 0.6 points for placebo, with p<0.0001.
  • Primary IgA nephropathy: In a domestic Phase III study, telitacicept met the primary endpoint in Stage A, reducing 24-hour UPCR by 55% versus placebo at Week 39, with p<0.0001.
• Drug Profile – Telitacicept / RC18:
  • Telitacicept / RC18: A first-in-class recombinant BLyS / APRIL dual-target fusion protein approved in China.
  • Mechanism: Designed to inhibit the binding of BLyS and APRIL to B-cell surface receptors, reducing abnormal B-cell differentiation, maturation and autoimmune activity.
  • Indication Focus: Autoimmune diseases driven by B-cell activation and pathogenic antibody production, including Sjögren’s syndrome, IgA nephropathy and systemic lupus erythematosus.
  • Regulatory Status: Approved by NMPA for five indications in China.

Qilu Pharma’s Safinamide Mesylate Tablets Approved in China for Parkinson’s Disease

Key Words: Qilu Pharma, safinamide mesylate, Parkinson’s disease, MAO-B inhibitor, NMPA approval, generic drug, domestic approval

• The News: Qilu Pharma received NMPA approval for safinamide mesylate tablets, becoming the second domestic company after Kelun Pharma (002422.SZ) to obtain approval for this product in China.
• Key Highlights:
• Regulatory Status:
  • Approval: Safinamide mesylate tablets were approved by China NMPA.
  • Safinamide was originally developed by Zambon and Newron, and has been approved in the EU, the U.S. and China.
• Drug Profile – Safinamide Mesylate:
  • Safinamide Mesylate: An oral anti-Parkinson’s disease drug used as adjunctive therapy for Parkinson’s disease.
  • Mechanism: A selective and reversible monoamine oxidase-B inhibitor, designed to increase dopaminergic activity by reducing dopamine breakdown.
  • Indication Focus: Parkinson’s disease, a chronic neurodegenerative disorder characterized by motor symptoms such as tremor, rigidity and bradykinesia.
• Qilu Pharma is a leading China-based pharmaceutical company with broad capabilities across innovative medicines, biosimilars and high-quality generics.

Gracell’s CD19/BCMA CAR-T GC012F Accepted by China CDE, Backed by AstraZeneca (AZN.O) Partnership

Key Words: Gracell, AstraZeneca, GC012F, CD19/BCMA CAR-T, FasT CAR, multiple myeloma, IND acceptance, cell therapy

• The News: China CDE accepted the IND application for GC012F injection, a CD19/BCMA dual-target autologous CAR-T therapy jointly submitted by Gracell Biotechnologies and AstraZeneca. The acceptance marks a new step in the China clinical development of GC012F, following AstraZeneca’s global collaboration with Gracell.
• Key Highlights:
• Regulatory Status:
  • Application: IND application for GC012F injection accepted by China CDE.
  • Registration Category: Class 1 therapeutic biological product.
• Clinical Data:
  • In relapsed / refractory multiple myeloma patients, GC012F achieved an ORR of 94.7% and CR/sCR rate of 84.2% in reported clinical data.
  • At a median follow-up of 18 months, 78.9% of patients remained progression-free.
  • Safety Profile: No Grade ≥3 CRS reported in the disclosed dataset.
• Drug Profile – GC012:
  • GC012F: A dual-target autologous CAR-T therapy targeting CD19 and BCMA, developed using Gracell’s proprietary FasT CAR® manufacturing platform.
  • Mechanism: Designed to target both BCMA and CD19, aiming to deepen response and reduce relapse risk associated with antigen escape in multiple myeloma and other B-cell malignancies.
  • Indication Focus: Relapsed / refractory multiple myeloma, with additional potential in CD19- and BCMA-positive hematologic malignancies.

InventisBio’s (688382.SS) KRAS G12C Inhibitor Garsorasib Shows Updated Combination Data with Ifebemtinib at ASCO 2026

Key Words: InventisBio, InxMed, garsorasib, D-1553, ifebemtinib, IN10018, KRAS G12C, FAK inhibitor, NSCLC, colorectal cancer, ASCO 2026

• The News: InventisBio’s KRAS G12C inhibitor garsorasib, in combination with InxMed’s FAK inhibitor ifebemtinib, showed updated clinical efficacy and safety data in KRAS G12C-mutant non-small cell lung cancer and colorectal cancer at ASCO 2026.
• Key Highlights:
• Clinical Data – KRAS G12C-mutant NSCLC:
  • Study Design: Open-label Phase Ib/II study evaluating ifebemtinib 100 mg QD plus garsorasib 600 mg BID in treatment-naïve locally advanced or metastatic KRAS G12C-mutant NSCLC, regardless of PD-L1 expression.
  • Patient Population: 33 first-line NSCLC patients were enrolled; 81.8% had stage IV disease. Median follow-up was 24.9 months.
  • Survival: The 24-month OS rate was 69.7%, and median OS was not reached.
  • Safety: Most TRAEs were Grade 1-2; Grade ≥3 TRAEs occurred in 24.2% of patients. No treatment-related deaths or permanent discontinuations due to adverse events were reported.
• Drug Profile – Garsorasib / D-1553:
  • Garsorasib / D-1553: An oral, selective and irreversible KRAS G12C small-molecule inhibitor.
  • Mechanism: Designed to covalently bind KRAS G12C and lock the mutant KRAS protein in an inactive state, thereby inhibiting downstream MAPK signaling.
  • Achieved ORR of 52.0%, DCR of 88.6%, median DoR of 12.5 months, median PFS of 9.1 months and median OS of 14.1 months.
• Drug Profile – Ifebemtinib / IN10018:
  • Ifebemtinib / IN10018: A potentially first-in-class, oral and highly selective FAK inhibitor developed by InxMed.
  • Mechanism: Designed to inhibit focal adhesion kinase signaling, which is involved in tumor cell survival, invasion, metastasis and resistance to targeted or immune therapies.

Shouyao’s (688197.SH) RET Inhibitor Sotrexateinib Meets Primary Endpoint in Phase III RET Fusion-Positive NSCLC Study

Key Words: Shouyao, sotrexateinib, SY-5007, RET inhibitor, RET fusion-positive NSCLC, ASCO 2026, NDA, targeted therapy

• The News: Shouyao Holdings’selective RET inhibitor sotrexateinib / SY-5007 showed strong antitumor activity in a pivotal Phase III study for treatment-naïve RET fusion-positive advanced NSCLC at ASCO 2026. The NDA for sotrexateinib has been accepted by China NMPA for adult patients with locally advanced or metastatic RET fusion-positive NSCLC.
• Key Highlights:
• Clinical Data:
  • Study Design: Multicenter, single-arm Phase III study evaluating sotrexateinib monotherapy in treatment-naïve patients with locally advanced or metastatic RET fusion-positive NSCLC.
  • Patient Population: As of April 10, 2025, 95 patients were included in the per-protocol population, including 61 patients in the key efficacy population.
  • Primary Endpoint: BICR-confirmed ORR assessed by RECIST v1.1.
  • Efficacy: BICR-confirmed ORR was 90.0% in the key efficacy population and 87.4% in the per-protocol population.
  • Disease control: DCR was 96.7% in the key efficacy population and 93.7% in the per-protocol population.
• Drug Profile – Sotrexateinib / SY-5007:
  • Sotrexateinib / SY-5007: A highly selective small-molecule RET tyrosine kinase inhibitor developed by Shouyao for RET-altered solid tumors.
  • Mechanism: Designed to selectively inhibit RET kinase activity and block downstream oncogenic signaling driven by RET fusions or RET mutations.
  • Indication Focus: RET fusion-positive locally advanced or metastatic NSCLC, with broader potential in RET-altered solid tumors.
  • Regulatory status: The NDA has been accepted by China NMPA for adult patients with RET fusion-positive locally advanced or metastatic NSCLC.

2026 Selesta

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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