This week, biotech highlights include Junshi’s RMB 1.34B Fosun deal (roconkibart), Innovent’s Verzenios rights, Yimiao’s RMB 3.8B STAR IPO (CAR-T), Insilico’s $600M Takeda AI partnership, and CSPC’s $1.77B AstraZeneca siRNA collaboration, spanning oncology, autoimmune, and AI drug discovery.

Transactions & BD (In/Out Licensing)

Junshi Biosciences (1877.HK) Licenses IL-17A Antibody Roconkibart to Fosun Wanbang in RMB 1.34 Billion Deal

Key Words: Junshi Biosciences, Fosun Wanbang, Fosun Pharma, roconkibart, JS005, IL-17A, plaque psoriasis, ankylosing spondylitis, Greater China license

• The News: Junshi Biosciences entered into a licensing agreement with Fosun Wanbang, a wholly owned subsidiary of Fosun Pharma (2196.HK), for roconkibart / JS005 in Greater China. Fosun Wanbang will obtain development, registration, manufacturing and commercialization rights, while Junshi will receive RMB 215 million upfront, up to RMB 1.125 billion in development and sales milestones, and double-digit tiered royalties.
• Key Highlights:
• Deal Details:
  • Upfront Payment: RMB215 million, non-refundable and non-creditable.
  • Milestone Payments: up to RMB125 billion linked to product development and sales.
  • Total Deal Value: up to RMB34 billion, excluding royalties.
• Product Profile – Roconkibart / JS005:
  • Roconkibart: a selective anti-IL-17A monoclonal antibody developed by Junshi for autoimmune and inflammatory diseases.
  • Mechanism: binds both IL-17A homodimers and IL-17A/IL-17F heterodimers, preventing their interaction with the IL-17RA/IL-17RC receptor complex and suppressing downstream inflammatory signaling.
  • Indication Focus: moderate-to-severe plaque psoriasis and ankylosing spondylitis, with broader potential across IL-17-driven autoimmune diseases.
  • Indication Focus: third-line treatment of r/r NHL.
• Clinical Data:
  • In the completed China Phase III study in moderate-to-severe plaque psoriasis, the 150 mg group achieved a PASI 90 response rate of 91% at Week 16.
  • The PASI 100 response rate reached 65% at Week 52, supporting rapid and durable skin clearance.

Innovent Biologics (1801.HK) Secures Mainland China Commercialization Rights to Lilly’s (LLY.N) Verzenios

Key Words: Innovent Biologics, Eli Lilly, Verzenios, abemaciclib, CDK4/6 inhibitor, breast cancer, commercialization agreement, mainland China

• The News: Innovent Biologics (1801.HK) entered into a distribution and promotion agreement with Eli Lilly (LLY.N) for Verzenios® / abemaciclib in mainland China. Innovent will be responsible for importation, marketing, distribution and promotion, while Lilly will retain manufacturing, supply, product development and marketing authorization holder responsibilities.
• Key Highlights:
• Product Profile – Verzenios / Abemaciclib:
  • Verzenios: an oral CDK4/6 inhibitor developed by Lilly for HR-positive, HER2-negative breast cancer across early-stage and advanced disease settings.
  • Mechanism:selectively inhibits CDK4 and CDK6, preventing retinoblastoma protein phosphorylation and blocking tumor-cell progression from the G1 to S phase of the cell cycle.
  • Indication Focus: high-risk, node-positive early breast cancer and locally advanced or metastatic HR-positive, HER2-negative breast cancer, including ESR1-mutated disease in combination with imlunestrant.
  • Indication Focus: moderate-to-severe plaque psoriasis and ankylosing spondylitis, with broader potential across IL-17-driven autoimmune diseases.
  • Regulatory Status: approved in China across multiple early and advanced breast cancer indications.

Yimiao Shenzhou Files for STAR Market IPO With a Post-Money Valuation of RMB 3.8 Billion

Key Words: Yimiao Shenzhou, STAR Market, IPO, CAR-T, IM19, cell therapy, China

• The News: Yimiao Shenzhou, a Beijing-based CAR-T developer, submitted its STAR Market IPO application on June 30, 2026, with plans to issue up to 10 million shares and raise RMB 2.5 billion. The company’s lead asset IM19, an autologous CAR-T for relapsed/refractory non-Hodgkin lymphoma, was filed for marketing approval in November 2024 and has a commercialization partnership with Huadong Medicine.
• Key Highlights:
• Deal Details:
  • IPO plan: up to 10 million new shares, representing at least 25% of post-IPO total shares, targeting RMB 2.5 billion in proceeds.
  • Use of proceeds: RMB 1.647 billion for cell therapy R&D, RMB$ 228 million for a Shandong manufacturing facility, RMB 625 million for working capital.
  • Latest financing: RMB 396.62 million Series G closed between December 2024 and March 2025 at a pre-money valuation of RMB 3.4 billion, post-money RMB 3.8 billion.
• Product Profile – IM19:
  • IM19: autologous CAR-T targeting CD19 for relapsed/refractory non-Hodgkin lymphoma, filed for NMPA approval in November 2024.
  • Mechanism: CD19-directed CAR-T cell therapy.
  • Indication Focus: third-line treatment of r/r NHL.
  • Development Stage: NDA under NMPA review; commercialization rights in China licensed to Huadong Medicine in August 2024.
• Yimiao Shenzhou: a Chinese biotech founded in 2015, focused on innovative CAR-T cell therapies including autologous, universal, and in vivo CAR-T platforms.

Insilico Medicine (3696.HK) and Takeda (TYO: 4502) Enter US$ 600 Million AI Drug Discovery Collaboration

Key Words: Insilico Medicine, Takeda, AI drug discovery, Pharma.AI, collaboration

• The News: Insilico Medicine announced a global strategic collaboration with Takeda to leverage its end-to-end Pharma.AI platform for discovering candidate drugs across multiple disease areas selected by Takeda. Insilico will receive approximately US$ 60 million in upfront and near-term milestone payments, with total potential milestone payments up to US$ 600 million plus tiered royalties on net sales.
• Key Highlights:
• Deal Details:
  • Total Deal Value: up to US$ 600 million in milestones plus tiered royalties.
  • Upfront / Near-term Payments: approximately US$ 60 million.
  • Rights Granted: Takeda receives exclusive global rights to develop, manufacture, and commercialize novel therapies from the collaboration.
  • Deal Structure: Insilico leads AI-driven drug discovery and candidate design; Takeda handles clinical development.
• Platform Profile – Pharma.AI:
  • AI: Insilico’s proprietary end-to-end AI platform for generative drug discovery and optimization.
  • Mechanism: applies generative AI models to early-stage drug design for best-in-class efficacy and safety profiles.
  • Indication Focus: multiple disease areas selected by Takeda.

CSPC Pharmaceutical Group (1093.HK) and AstraZeneca (AZN) Enter US$ 1.77 Billion siRNA Discovery Collaboration

Key Words: siRNA, kidney disease, CSPC, AstraZeneca, oligonucleotide, AI screening, licensing

• The News: CSPC Pharmaceutical Group and AstraZeneca (AZN) signed a collaboration, option and license agreement to discover and develop novel siRNA candidates using CSPC’s proprietary siRNA platform and extrahepatic delivery technology. The deal covers two targets for multiple kidney disease indications, with AstraZeneca holding exclusive global or ex-China rights to each preclinical candidate and CSPC retaining full China rights for one candidate.
• Key Highlights:
• Deal Details:
  • Total Deal Value: up to US$ 1.77 billion, comprising US$ 30 million upfront, up to US$ 540 million in R&D milestones, and up to US$ 1.2 billion in sales milestones.
  • Royalties: tiered single-digit percentage on annual net sales.
  • Rights Structure: AstraZeneca can opt into exclusive global or ex-China development, manufacturing and commercialization rights per candidate; CSPC retains full China rights for one candidate.
• Platform Profile – CSPC siRNA Platform:
  • CSPC siRNA Platform: an AI-driven molecular design model combined with fully automated high-throughput screening to identify high-activity nucleic acid molecules with enhanced extrahepatic targeting potential.
  • Indication Focus: kidney disease, multiple indications.
  • Development Stage: preclinical candidate (PCC) discovery phase.

METiS Therapeutics (7666.HK) Licences Trispecific TCE to Boulevard Bio in Deal Worth up to US$ 1.6 Billion

Key Words: METiS Therapeutics, Boulevard Bio, trispecific T-cell engager, CD19, BCMA, CD3, AI drug discovery

• The News: METiS Therapeutics granted Boulevard Bio an exclusive global licence for MTS-128, a preclinical trispecific T-cell engager targeting CD19, BCMA, and CD3 with an HSA-binding domain. METiS receives US$ 20 million upfront and is eligible for up to US$ 1.6 billion in milestones plus tiered royalties.
• Key Highlights:
• Deal Details:
  • Total Deal Value: up to US$ 1.6 billion in development, regulatory, and commercial milestones.
  • Upfront Payment: US$ 20 million.
  • Rights Granted: exclusive global licence for MTS-128.
• Product Profile – MTS-128:
  • MTS-128: a preclinical trispecific T-cell engager designed to engage CD19 and BCMA on target cells and CD3 on T cells.
  • Mechanism: engaged CD19- and BCMA-expressing target cells and CD3-positive T cells, redirecting T-cell cytotoxicity toward malignant or pathogenic B-lineage cells.
  • Indication Focus: B-cell malignancies and autoimmune indications (B-cell depletion for immune reset).
  • Development Stage: preclinical.

Clinical

Hybio Pharmaceutical (300199.SZ) Files for US Marketing Approval of Tirzepatide

Key Words: Hybio, tirzepatide, ANDA, FDA, GLP-1, GIP, obesity, diabetes, Paragraph IV

• The News: Hybio Pharmaceutical announced its Abbreviated New Drug Application (ANDA) for tirzepatide injection has been accepted for review by the US FDA, which preliminarily deemed the submission substantially complete. The filing, submitted on the earliest permissible date of May 13, 2026, includes a Paragraph IV patent challenge and positions Hybio as a potential first-to-file generic for the GLP-1R/GIPR dual agonist that generated approximately US$ 36.5 billion in global sales for Eli Lilly in 2025.
• Key Highlights:
• Clinical Data:
  • Study Design: ANDA filing for tirzepatide injection, a GLP-1R/GIPR dual agonist, referencing Eli Lilly’s Mounjaro (diabetes) and Zepbound (obesity).
  • Regulatory Status: FDA accepted the ANDA for review; Hybio submitted two ANDAs with Paragraph IV patent certification on the earliest filing date.
• Product Profile – Tirzepatide:
  • Tirzepatide: a GLP-1R/GIPR dual agonist for type 2 diabetes and obesity.
  • Mechanism: dual agonism of glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors.
  • Indication Focus: glycemic control in type 2 diabetes and chronic weight management.
  • Development Stage: ANDA under FDA review; Hybio’s tirzepatide API DMF is the first to pass FDA completeness assessment.

HUTCHMED (0013.HK) Secures China Approval for Savolitinib in Gastric Cancer

Key Words: savolitinib, gastric cancer, MET amplification, HUTCHMED, NMPA approval

• The News: China’s NMPA approved HUTCHMED’s savolitinib for adult patients with MET gene-amplified locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed at least two prior systemic chemotherapies. This marks the third approved indication for savolitinib in China, following approvals in MET exon 14 skipping NSCLC and combination therapy with osimertinib in EGFR-mutant NSCLC.
• Key Highlights:
• Clinical Data:
  • Study Design: single-arm trial evaluating savolitinib in MET-amplified gastric cancer patients after ≥2 prior systemic therapies.
  • Primary Endpoint: objective response rate and duration of response.
  • Regulatory Status: NMPA approval granted July 2, 2026.
• Product Profile – Savolitinib:
  • Savolitinib: an oral, highly selective c-Met inhibitor developed by HUTCHMED.
  • Mechanism: blocks abnormal MET receptor tyrosine kinase signaling caused by mutations, gene amplification, or protein overexpression.
  • Indication Focus: MET gene-amplified gastric cancer; also approved in MET exon 14 skipping NSCLC and combination with osimertinib in EGFR-mutant NSCLC.
  • Development Stage: marketed in China; global development led by AstraZeneca under a 2011 collaboration.

Eli Lilly (LLY.N) RET inhibitor selpercatinib granted priority review for adjuvant NSCLC treatment

Key Words: selpercatinib, RET inhibitor, NSCLC, adjuvant therapy, priority review, LIBRETTO-432

• The News: China’s CDE has granted priority review to Eli Lilly’s selpercatinib for adjuvant treatment of stage IB-IIIA RET fusion-positive NSCLC after radical local therapy. The filing follows the phase 3 LIBRETTO-432 study, which met its primary endpoint in February 2025 with a significant event-free survival benefit versus placebo.
• Key Highlights:
• Clinical Data – LIBRETTO-432:
  • Study Design: phase 3, randomized, placebo-controlled, evaluating selpercatinib 120mg or 160mg BID as adjuvant therapy in RET fusion-positive NSCLC patients after complete resection.
  • Primary Endpoint: in the main analysis population (stage II-IIIA), investigator-assessed median EFS not reached vs 31.8 months (HR=0.172, p=0.0003); 2-year EFS rates 91.5% vs 61.1%.
  • BICR Assessment: in the main population, median EFS HR=0.125; 2-year EFS rates 95.6% vs 70.8%.
  • Full Population (IB-IIIA): investigator-assessed median EFS HR=0.165 (p=0.0002); 2-year EFS rates 93.8% vs 69.6%.
• Product Profile – Selpercatinib:
  • Selpercatinib: a potent, highly selective oral RET tyrosine kinase inhibitor, first approved globally by the FDA in May 2020 as the first selective RET inhibitor.
  • Mechanism: selective RET kinase inhibition targeting RET fusion and mutation-driven tumors.
  • Indication Focus: RET fusion-positive NSCLC (adjuvant and advanced), RET-mutant medullary thyroid cancer, RET fusion-positive thyroid cancer.
  • Regulatory Status: approved in China since October 2022 for advanced RET fusion-positive NSCLC and RET-driven thyroid cancers; adjuvant indication not yet approved globally.

Merck KGaA Files First-in-Class Therapy for Desmoid Tumours in China

Key Words: nirogacestat, γ-secretase inhibitor, desmoid tumours, NDA, Phase III

• The News: Merck KGaA has submitted a New Drug Application in China for nirogacestat, an oral γ-secretase inhibitor for progressive desmoid tumours in adults requiring systemic therapy. The filing is supported by the Phase III DeFi trial, which showed a median PFS not reached versus 15.1 months for placebo (HR=0.29, p<0.001) and a 41% confirmed ORR versus 8% for placebo.
• Key Highlights:
• Clinical Data – DeFi Trial:
  • Study Design: Phase III, placebo-controlled, in adults with progressive desmoid tumours requiring systemic therapy.
  • Primary Endpoint: median PFS not reached versus 15.1 months for placebo (HR=0.29, p<0.001).
  • Efficacy: confirmed ORR 41% versus 8% for placebo.
• Product Profile – Nirogacestat:
  • Nirogacestat: an oral, selective γ-secretase inhibitor, the first approved therapy globally for desmoid tumours.
  • Mechanism: inhibits γ-secretase, blocking Notch signaling involved in tumour growth.
  • Indication Focus: progressive desmoid tumours (aggressive fibromatosis).
  • Development Stage: NDA filed in China; first approved in the US in November 2023.

Insilico Medicine (3696.HK) Advances First AI-Discovered Drug into Phase III for Idiopathic Pulmonary Fibrosis

Key Words: Insilico Medicine, rentosertib, TNIK, AI-discovered drug, idiopathic pulmonary fibrosis, Phase III, Pharma.AI

• The News: Insilico Medicine has initiated a Phase III trial for rentosertib, a first-in-class TNIK inhibitor discovered via its generative AI platform Pharma.AI, in 320 patients with idiopathic pulmonary fibrosis. This marks the first wholly AI-discovered and AI-designed drug to reach Phase III development.
• Key Highlights:
• Clinical Data:
  • Study Design: double-blind, placebo-controlled Phase III trial enrolling 320 IPF patients, evaluating once-daily oral rentosertib on FVC decline.
  • Patient Population: approximately 320 patients with idiopathic pulmonary fibrosis.
  • Treatment: once-daily oral rentosertib, using the tablet formulation.
  • Efficacy: Phase IIa data (60 mg QD capsule) showed a 118.7 ml FVC difference versus placebo at 12 weeks; tablet formulation used in Phase III.
  • Unmet Need: IPF affects ~5 million people globally with limited treatment options that only slow progression.
• Drug Profile – Rentosertib:
  • Rentosertib: a first-in-class, orally administered small-molecule inhibitor of TNIK being developed as a potential disease-modifying therapy.
  • Mechanism: inhibited TNIK, a signaling protein implicated in fibrotic and inflammatory pathways.
  • Indication Focus: idiopathic pulmonary fibrosis, with potential application in other fibrotic diseases.
  • Development Stage: Phase III.

AstraZeneca (LON: AZN) Files First-in-Class IL-33 mAb Tozorakimab for Approval in China for COPD

Key Words: tozorakimab, IL-33, AstraZeneca, COPD, Phase III, regulatory filing

• The News: AstraZeneca submitted a marketing authorisation application to China’s CDE for tozorakimab, a first-in-class monoclonal antibody targeting both reduced and oxidised forms of IL-33. The filing is supported by three Phase III trials (OBERON, TITANIA, MIRANDA) showing statistically significant reductions in annualised moderate-to-severe COPD exacerbation rates across subgroups.
• Key Highlights:
• Clinical Data:
  • Study Design: three Phase III trials (OBERON, TITANIA, MIRANDA) in COPD patients.
  • Efficacy: statistically significant reductions in annualised moderate-to-severe exacerbation rates across subgroups including current and former smokers and varying baseline eosinophil counts and disease severity.
• Product Profile – Tozorakimab:
  • Tozorakimab: first-in-class monoclonal antibody targeting IL-33, binding both reduced and oxidised forms to inhibit signalling.
  • Mechanism: reduced airway inflammation and mucus hypersecretion.
  • Indication Focus: chronic obstructive pulmonary disease (COPD).
  • Development Stage: regulatory filing in China; first IL-33 inhibitorglobally to reach filing stage.

Hengrui Medicine (600276.SH) KRAS G12C Inhibitor HRS-7058 Granted Breakthrough Therapy Designation in China After 100% ORR in Pancreatic Cancer

Key Words: Hengrui Medicine, HRS-7058, KRAS G12C, pancreatic cancer, Breakthrough Therapy Designation, CDE

• The News: Hengrui Medicine’s investigational KRAS G12C covalent inhibitor HRS-7058 received Breakthrough Therapy Designation from China’s CDE for previously treated KRAS G12C-mutated locally advanced or metastatic pancreatic ductal adenocarcinoma. Early-phase data showed a 100% objective response rate in three evaluable patients at a median follow-up of 3.9 months, highlighting strong preliminary activity in a high-unmet-need indication.
• Key Highlights:
• Clinical Data:
  • Study Design: early-phase trial in previously treated KRAS G12C-mutated locally advanced or metastatic PDAC; three evaluable patients.
  • Efficacy: objective response rate of 100% at median follow-up of 3.9 months.
  • Regulatory Status: Breakthrough Therapy Designation granted by China’s CDE to expedite review.
• Product Profile – HRS-7058:
  • HRS-7058: an investigational oral covalent inhibitor targeting KRAS G12C mutations.
  • Mechanism: irreversible binding to the KRAS G12C mutant protein, blocking downstream signaling.
  • Indication Focus: KRAS G12C-mutated locally advanced or metastatic pancreatic ductal adenocarcinoma.
  • Development Stage: entered clinical development in 2024; BTD granted in China.

3SBio (1530.HK) Semaglutide Injection WS2403 Marketing Application Accepted

Key Words: semaglutide, GLP-1, obesity, weight management, 3SBio, WS2403

• The News: 3SBio announced that the China NMPA has accepted the marketing application for its semaglutide injection WS2403 for chronic weight management in adults with obesity or overweight plus at least one weight-related comorbidity, as an adjunct to diet and exercise. The filing is supported by a Phase III trial showing WS2403 achieved a 14.54% mean body weight reduction from baseline at 44 weeks, demonstrating equivalence to the reference product Novo Nordisk’s Wegovy.
• Key Highlights:
• Clinical Data:
  • Study Design: multicenter, randomized, open-label Phase III trial comparing WS2403 versus Novo Nordisk’s Wegovy over 44 weeks in obese patients.
  • Efficacy: WS2403 produced a 14.54% mean body weight reduction from baseline at 44 weeks, equivalent to the reference product.
  • Regulatory Status: marketing application accepted by China’s CDE for review.
• Product Profile – WS2403:
  • WS2403: a chemically synthesized GLP-1 receptor agonist semaglutide injection for chronic weight management.
  • Mechanism: selectively binds and activates GLP-1 receptors in appetite-regulating brain regions, reducing energy intake, increasing satiety, and decreasing hunger and food cravings.
  • Indication Focus: long-term weight management in adult patients with obesity (BMI ≥ 28 kg/m²) or overweight (BMI ≥ 24 kg/m²) with at least one weight-related comorbidity, combined with diet and exercise.

Sinotau’s PSMA-Targeted Radiopharmaceutical XTR021 Cleared for Clinical Development in mCRPC

Key Words: Sinotau Pharmaceuticals, XTR021, radiopharmaceutical, lutetium-177, PSMA, mCRPC, radioligand therapy, NMPA clearance

• The News: Sinotau Pharmaceuticals received NMPA clearance for the clinical trial application of XTR021, a Class 1 innovative lutetium-177-labelled PSMA-targeted radiopharmaceutical for metastatic castration-resistant prostate cancer. Preclinical and early investigator-initiated study data support its potential as a differentiated next-generation PSMA radioligand therapy.
• Key Highlights:
• Clinical trial application approved by China NMPA.
• Product Profile – XTR021:
  • XTR021: a lutetium-177-labelled radioligand therapy targeting prostate-specific membrane antigen for the treatment of PSMA-expressing prostate cancer.
  • Mechanism: selectively bind PSMA on prostate cancer cells and delivers β-particle radiation from lutetium-177 directly to tumors, inducing localized DNA damage and tumor-cell death while limiting radiation exposure to surrounding tissues.
  • Indication Focus: metastatic castration-resistant prostate cancer, particularly in patients with PSMA-positive disease.
• Sinotau Pharmaceuticals is a China-based radiopharmaceutical company focused on the discovery, development and commercialization of nuclear medicine products for oncology diagnosis and treatment.

GenEditBio’s In Vivo Genome-Editing Therapy GEB-101 Cleared by China NMPA for TGFBI-Related Corneal Dystrophies

Key Words: GenEditBio, GEB-101, in vivo genome editing, CRISPR-Cas, TGFBI, corneal dystrophy, PDV, IND clearance

• The News: GenEditBio received China NMPA clearance for the IND application of GEB-101, its lead in vivo genome-editing therapy for TGFBI-related corneal dystrophies. The clearance enables initiation of the multi-regional Phase I/II CLARITY trial in China and follows U.S. FDA IND clearance granted in December 2025.
• Key Highlights:
• Regulatory Status: China NMPA cleared the IND application for GEB-101.
• Clinical Development:
  • CLARITY: a seamless, adaptive, multicenter Phase I/II study evaluating the safety, tolerability and preliminary efficacy of GEB-101 in patients with TGFBI mutations.
  • Development Strategy: multi-regional clinical development across China and the U.S.
• Product Profile – GEB-101:
  • GEB-101: A first-in-class, in vivo somatic genome-editing therapy designed as a one-time treatment for TGFBI-related corneal dystrophies.
  • Mechanism:used a CRISPR-Cas ribonucleoprotein complex to edit a defined locus in the mutant TGFBI gene, aiming to reduce production and accumulation of pathogenic TGFBI protein in the cornea.
  • Indication Focus: genetic corneal dystrophies caused by TGFBI mutations, which lead to progressive corneal protein deposits, recurrent erosions, pain, photophobia and vision loss.
• GenEditBio is a Hong Kong-headquartered clinical-stage biotechnology company developing in vivo genome-editing therapies using proprietary Cas nucleases, lipid nanoparticles and engineered protein delivery vehicles.

Abbisko Therapeutics (2256.HK) and AstraZeneca (AZN.O) Advance Oral PD-L1 Inhibitor Combination in EGFR-Mutated NSCLC

Key Words: Abbisko Therapeutics, AstraZeneca, lumipodlin, ABSK043, osimertinib, Tagrisso, PD-L1 inhibitor, EGFR-mutated NSCLC, IO-TKI combination

• The News: Abbisko Therapeutics entered into a strategic clinical collaboration with AstraZeneca to evaluate lumipodlin / ABSK043, Abbisko’s oral small-molecule PD-L1 inhibitor, in combination with Tagrisso® / osimertinib in EGFR-mutated, PD-L1-positive locally advanced or metastatic NSCLC. The China IND for the multicenter Phase I/II study was cleared in May 2026.
• Key Highlights:
• Collaboration Detail:
  • Study Design: multicenter, open-label Phase I/II clinical study.
  • Regulatory Status: China NMPA cleared the IND application for the combination study on May 20, 2026.
  • Patient Population: patients with EGFR-mutated and PD-L1-positive locally advanced or metastatic NSCLC.
• Product Profile – Lumipodlin / ABSK043:
  • Lumipodlin: a potentially first-in-class, orally bioavailable and highly selective small-molecule PD-L1 inhibitor wholly developed by Abbisko.
  • Mechanism: binds PD-L1 and promotes its internalization from the tumor-cell surface, thereby disrupting PD-1/PD-L1 signaling and restoring T-cell-mediated antitumor activity.
  • Indication Focus: advanced solid tumors, with the current combination study focused on EGFR-mutated, PD-L1-positive locally advanced or metastatic NSCLC.
  • Development Stage: phase I development is ongoing in Australia and China.

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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