This weekly update highlights key developments in China’s healthcare sector, with major transactions and cutting-edge clinical advancements prominently featured at ASCO 2026. Haisco and Eli Lilly announced a US$3 billion R&D collaboration on small-molecule drug discovery, while Everest Medicines completed two pivotal deals, including a US$1.14 billion out-license of its BTK inhibitor to Travere Therapeutics and the in-license of Mabwork Biotech’s CD20 antibody for Asia-Pacific markets. Clinical breakthroughs took center stage at ASCO, with Akeso’s ivonescimab demonstrating OS benefits in sq-NSCLC, Innovent Biologics’ IBI363 showing encouraging efficacy in PD-L1 low-expression NSCLC, and Lupeng Pharma celebrating the approval of its fourth-generation BTK inhibitor rocbrutinib in mantle cell lymphoma. These milestones underscore China’s expanding global influence in oncology innovation and groundbreaking therapies.

Transactions & BD (In/Out Licensing)

Haisco (002653.SZ) and Eli Lilly (LLY.N) Enter US$ 3 Billion Discovery Collaboration Across Up to Five Novel Targets

Key Words: Haisco, Eli Lilly, R&D collaboration, small-molecule discovery, novel targets, global rights, ciprofol, anesthesia

• The News: Haisco Pharmaceutical entered a strategic R&D collaboration with Eli Lilly to discover and develop small-molecule candidates against up to five novel targets selected by Lilly. The deal is potentially worth over US$ 3 billion, including upfront / near-term payments, milestones and tiered royalties.
• Key Highlights:
• Deal Details:
  • Total Deal Value: Over US$ 3.0 billion.
  • Upfront / Near-term Payments: Up to US$ 87 million.
  • Milestone Payments: Up to US$ 97 billion in clinical, regulatory and commercial milestones.
  • Lilly will obtain global or ex-China exclusive rights to resulting candidates, while Haisco retains Greater China commercial rights for certain programs.
• Platform Profile – Small-Molecule Discovery Platform:
  • Small-Molecule Discovery Platform: Haisco’s internal small-molecule R&D platform used for novel target validation, hit discovery, lead optimization and early-stage candidate generation.
  • Collaboration scope: Under the Lilly collaboration, the platform will be used to conduct discovery and early-stage research for up to five Lilly-selected novel targets.
  • Expected to generate small-molecule drug candidates, for which Lilly may obtain global or ex-China exclusive rights.

Intellective Biologics Files for Hong Kong IPO with RMB 5.91 Billion Post-Money Valuation

Key Words: Intellective Biologics, HKEX IPO, biologics CDMO, antibody manufacturing, ADC manufacturing, commercial production, capacity expansion

• The News: Intellective Biologics filed for a Hong Kong IPO to support biologics manufacturing capacity expansion. Founded in 2018, the company operates a “one molecule, all-the-way” CDMO model covering early-stage development through commercial-scale manufacturing.
• Key Highlights:
• Deal Details:
  • IPO Status: Submitted listing application to the Hong Kong Stock Exchange.
  • Financing History: Raised approximately RMB 23 billion across six funding rounds.
  • Latest Valuation: Post-money valuation reached approximately RMB 91 billion in the most recent financing round.
  • Revenue: RMB 484 million in 2025.
  • Net loss: RMB 215 million in 2025.
• Core Service Platform – Biologics CDMO:
  • Biologics CDMO Platform: An integrated “one molecule, all-the-way” biologics CDMO platform.
  • Focused on biologics manufacturing services, including therapeutic antibodies and ADC-related production capabilities.
  • Capacity: Operated three manufacturing facilities with total production capacity of 113,400 liters, supporting both clinical-stage and commercial-stage biologics manufacturing.
• Intellective Biologics is a biologics CDMO focused on antibody and ADC manufacturing services across development and commercial production stages.

WuXi XDC (2268.HK) Secures TOT Biopharm’s (1875.HK) CDMO Revenue with Three-Year Order Guarantee

Key Words: WuXi XDC, TOT Biopharm, CDMO, ADC manufacturing, antibody manufacturing, Suzhou facility, revenue guarantee

• The News: After WuXi XDC acquired a controlling stake of over 60% in TOT Biopharm in March 2026, the two companies signed a series of service agreements, including a three-year CDMO service contract. The agreement provides minimum service fees of RMB 92.5 million in 2026, RMB 257 million in 2027 and RMB 425 million in 2028.
• Key Highlights:
• Deal Details:
  • Transaction Background: WuXi XDC acquired a controlling stake of over 60% in TOT Biopharm in March 2026.
  • Minimum Service Fees: RMB 5 million in 2026, RMB 257 million in 2027 and RMB 425 million in 2028.
  • Contract Structure: Three-year CDMO service agreement between WuXi XDC and TOT Biopharm.
• TOT Biopharm CDMO Platform: A biologics and ADC manufacturing platform with 20,000 liters of antibody production capacity and dedicated ADC production lines.
• Manufacturing Scope: Supports antibody drug and ADC development / manufacturing, with potential transition toward higher-value commercial-stage CDMO projects.

Everest Medicines (1952.HK) Executes Two BD Deals with Travere Therapeutics and Mabwork Biotech to Expand Renal and Autoimmune Portfolio

Key Words: Everest Medicines, Travere Therapeutics, Mabwork Biotech, civorebrutinib, EVER001, Bejescin, MIL62, CD20 antibody, PMN, NMOSD, renal diseases, autoimmune diseases

• The News: Everest Medicines completed two BD transactions. The company out-licensed global rights outside Greater China and selected East / Southeast Asian markets for civorebrutinib / EVER001 to Travere Therapeutics (TVTX.O) in a deal worth up to US$ 1.14 billion. Separately, Everest in-licensed Asia-Pacific clinical development and commercialization rights to Mabwork Biotech’s (874070.NQ) Bejescin / MIL62, a third-generation CD20 antibody, for selected Asia-Pacific markets.
• Key Highlights:
• Deal Details – Civorebrutinib / EVER001 Out-License to Travere:
  • Total Deal Value: Up to US$ 1.14 billion.
  • Upfront Payment: US$ 5 million.
  • Milestones: Up to approximately US$ 03 billion tied to clinical, regulatory and commercial progress across up to five indications.
• Deal Details – Bejescin / MIL62 In-License from Mabwork:
  • Upfront Payment: RMB 23 million.
  • Milestones: Up to RMB 180 million.
  • Rights Granted: Clinical development and commercialization rights in the licensed territory.
• Product Profile (Out-license) – Civorebrutinib / EVER001:
  • Civorebrutinib / EVER001: A potentially best-in-class BTK inhibitor being developed for immune-mediated kidney diseases.
  • Mechanism: Designed to inhibit BTK-mediated B-cell and immune signaling pathways involved in pathogenic autoantibody production and renal inflammation.
  • Clinical Data: In a Phase Ib/IIa PMN study, both low- and high-dose groups showed >93% reduction in anti-PLA2R autoantibody levels at Week 24, with sustained antibody suppression through Week 52 after treatment discontinuation.
• Product Profile (In-license) – Bejescin / MIL62:
  • Bejescin / MIL62: A third-generation CD20 monoclonal antibody developed by Mabwork and approved in China for AQP4 antibody-positive adult NMOSD, with PMN NDA under Priority Review.
  • Mechanism: Developed using an ADCC-enhanced antibody platform to deplete CD20-positive B cells, reducing pathogenic B-cell activity in autoimmune diseases.
  • Indication Focus: Approved for NMOSD in China; PMN is under regulatory review, while SLE and follicular lymphoma are in Phase III development.

Keymed Biosciences (2162.HK) Receives US$ 257 Million Upfront from Gilead’s (GILD.O) Acquisition of Ouro Medicines

Key Words: Keymed Biosciences, Gilead, Ouro Medicines, CM336, OM336, BCMA/CD3 TCE, NewCo, autoimmune diseases, multiple myeloma

• The News: Keymed Biosciences announced that it has received US$ 257 million upfront proceeds from Gilead Sciences’ acquisition of Ouro Medicines, a NewCo holding ex-Greater China rights to Keymed’s BCMA/CD3 bispecific antibody CM336 / OM336. Keymed is also eligible for up to US$ 70 million in acquisition-related milestones, while the original licensing agreement remains in place.
• Key Highlights:
• Deal Detail:
  • Keymed received US$ 16 million upfront / near-term payments, approximately 15% equity in Ouro, up to US$ 610 million in milestones and tiered royalties.
  • Gilead Acquisition: Gilead acquired Ouro for US$ 1.675 billion upfront and up to US$ 500 million in milestones.
  • As an Ouro shareholder, Keymed received US$ 257 million upfront and may receive up to US$ 70 million in additional milestones, implying total potential equity-sale proceeds of approximately US$ 320 million.
• Product Profile – CM336 / OM336:
  • CM336 / OM336: A BCMA/CD3 bispecific T-cell engager developed by Keymed, initially evaluated in relapsed / refractory multiple myeloma and now being advanced by Ouro for autoimmune diseases including autoimmune hemolytic anemia and immune thrombocytopenia.
  • Mechanism: Designed to bind BCMA on pathogenic plasma cells and CD3 on T cells, redirecting T cells to eliminate BCMA-expressing cells through T-cell-dependent cytotoxicity.
  • Clinical Data: In a Phase I/II study in relapsed / refractory multiple myeloma, CM336 showed ORR of 67% and 76% in higher-dose cohorts, with 52% of patients achieving sCR or CR and MRD negativity of 95% among 19 evaluable patients.
  • Safety: Most CRS events were Grade 1, and no ICANS was reported.

Sinopharm to Acquire 20% stake in AmoyDx (300685.SZ) in RMB 1.65 Billion Share Transfer

Key Words: AmoyDx, Sinopharm, equity transfer, companion diagnostics, molecular diagnostics, IVD, precision oncology

• The News: AmoyDx announced that its controlling shareholder Forebright Smart Connection Technology entered into a share transfer agreement with Sinopharm Group’s Beijing Technology Innovation Research Institute. Sinopharm will acquire 78.02 million shares, representing 20.0% of AmoyDx’s total share capital, at RMB 21.20 per share for a total consideration of approximately RMB 1.65 billion.
• Key Highlights:
• Deal Details:
  • Transaction Size: Approximately RMB 65 billion.
  • Shares Transferred: 78.02 million shares, representing 20.0% of AmoyDx’s total share capital.
• Financial Profile:
  • 2025 Revenue: RMB 20 billion, up 8.01% YoY.
  • 2025 Net Profit Attributable to Shareholders: RMB 361 million, up 41.74% YoY.
  • R&D investment has remained around 15% of revenue.
• AmoyDx: A China-listed molecular diagnostics company focused on oncology precision medicine, companion diagnostics and clinical testing services.

Clinical

Akeso’s (9926.HK) Ivonescimab Shows OS Benefit in First-Line sq-NSCLC at ASCO 2026

Key Words: Hengrui Pharma, HRS-5635, HBV, siRNA, chronic hepatitis B, Phase III, HBeAg-negative

• The News: Akeso presented Phase III HARMONi-6 data for ivonescimab plus chemotherapy in the ASCO 2026 Plenary Session. In first-line advanced squamous NSCLC, ivonescimab plus chemotherapy significantly improved overall survival and progression-free survival versus tislelizumab plus chemotherapy.
• Key Highlights:
• Clinical Data:
  • Study Design: Phase III HARMONi-6 / AK112-306 enrolled 532 patients with advanced squamous NSCLC, comparing ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in the first-line setting.
  • Overall Survival: At a median follow-up of 21.36 months, ivonescimab reduced risk of death by 34% versus control, with HR of 0.66, median OS of 27.9 months versus 23.7 months, and p=0.0017.
  • Landmark OS: 12-month OS rate was 78.9% versus 72.2%, and 24-month OS rate was 64.7% versus 48.6% for ivonescimab and control, respectively.
  • Safety: Grade ≥3 TRAEs occurred in 69.2% of patients in the ivonescimab arm versus 58.9% in the control arm; adverse events leading to discontinuation or death were similar between arms.
• Drug Profile – Ivonescimab:
  • Ivonescimab: A first-in-class PD-1/VEGF bispecific antibody being developed across multiple solid tumors, including first-line advanced squamous NSCLC.
  • Mechanism: Designed to simultaneously block PD-1-mediated immune suppression and VEGF-mediated angiogenesis, combining immune checkpoint inhibition and anti-angiogenic activity in one molecule.
  • Indication Focus: NSCLC, including first-line squamous NSCLC, PD-L1-positive NSCLC and EGFR-mutant non-squamous NSCLC after TKI failure.
  • Development Stage: More than 30 clinical studies ongoing, including 15 Phase III trials and seven head-to-head studies versus PD-1/PD-L1 therapies.

Innovent’s (1801.HK) IBI363 Shows Early PoC Efficacy in First-Line NSCLC at ASCO 2026

Key Words: Innovent Biologics, IBI363, TAK-928, PD-1/IL-2α-bias bispecific fusion protein, ASCO 2026, NSCLC, PD-L1 low expression, Takeda

• The News: Innovent Biologics presented preliminary PoC data of IBI363 plus chemotherapy in first-line advanced NSCLC at the 2026 ASCO Annual Meeting. In PD-L1 negative or low-expression NSCLC, the optimized 3→1.5mg/kg dose regimen showed encouraging response activity and manageable safety. IBI363 is being globally co-developed with Takeda.
• Key Highlights:
• Clinical Data:
  • Study Design: Phase I PoC study evaluated IBI363 plus platinum-based doublet chemotherapy in previously untreated locally advanced or metastatic NSCLC.
  • Patient Population: As of December 22, 2025, 80 patients were enrolled, including 11 in safety lead-in and 69 in dose optimization; 65.2% of patients in the dose-optimization phase had PD-L1 TPS <1% and 34.8% had TPS 1-49%.
  • Efficacy: In the 3→5mg/kg dose group (n=22), ORR was 86.4%, confirmed ORR was 81.8% and DCR was 100%.
  • Safety: Grade ≥3 TEAEs occurred in 65.2% of patients in the 3→5mg/kg group, lower than the 1.5mg/kg group and 3mg/kg group.
• Product Profile – IBI363 / TAK-928:
  • IBI363 / TAK-928: A first-in-class PD-1/IL-2α-bias bispecific fusion protein being developed for multiple solid tumors, including NSCLC, melanoma and colorectal cancer.
  • Mechanism: Designed to block the PD-1/PD-L1 pathway while selectively activating IL-2 signaling through IL-2Rα, aiming to enhance anti-tumor T-cell immunity while reducing IL-2Rβ/γ-related toxicity.
  • Dosing Strategy: The 3→1.5mg/kg regimen uses 3mg/kg in cycle 1 to initiate immune activation, followed by 1.5mg/kg Q3W maintenance to support continued treatment in IO-naïve NSCLC.
  • Regulatory Status: IBI363 has received two U.S. FDA Fast Track Designations and three China NMPA Breakthrough Therapy Designations.

Hengrui (600276.SH, 1276.HK) Presents Multiple Oncology Data Updates at ASCO 2026

Key Words: Hengrui, ASCO 2026, pyrotinib, camrelizumab, apatinib, SHR-A2102, adebrelimab, trastuzumab rezetecan, breast cancer, HCC, bladder cancer, colorectal cancer

• The News: Hengrui presented multiple oncology clinical updates at the 2026 ASCO Annual Meeting, covering HER2-positive early breast cancer, unresectable hepatocellular carcinoma, muscle-invasive bladder cancer and HER2-positive metastatic colorectal cancer. Key readouts included a non-inferior neoadjuvant HER2 regimen for early breast cancer, positive Phase III data in uHCC, perioperative Phase II activity in MIBC and positive Phase III results for trastuzumab rezetecan in HER2-positive CRC.
• Key Highlights:
• Drug Profile – Key Assets:
  • Pyrotinib: An oral pan-HER TKI being evaluated in HER2-positive early breast cancer as part of a neoadjuvant nab-paclitaxel and trastuzumab combination regimen.
  • Camrelizumab / Apatinib: A PD-1 antibody plus VEGFR2 TKI combination being developed with TACE for unresectable HCC, with the NMPA accepting a marketing authorization application in early 2026.
  • SHR-A2102: An investigational ADC being evaluated in combination with the PD-L1 antibody adebrelimab for perioperative treatment of muscle-invasive bladder cancer.
  • Trastuzumab rezetecan: A HER2-targeted ADC being developed for HER2-positive metastatic colorectal cancer, with NMPA Priority Review granted based on positive Phase III HORIZON-CRC01 data.
• Clinical Data:
  • HELEN HER-013: In HER2-positive early breast cancer, neoadjuvant nab-PHPy, consisting of nab-paclitaxel, trastuzumab and oral pyrotinib, was non-inferior to standard TCHP, with pCR of 61.0% v 57.1% and non-inferiority p=0.004.
    • Safety: nab-PHPy reduced platinum-related toxicities, while TKI-related diarrhea was manageable, supporting its potential as a chemotherapy de-escalation option.
  • CARES-336: In unresectable HCC, camrelizumab plus apatinib and TACE significantly improved median PFS versus TACE alone, at 11.1 months versus 8.3 months, with HR=0.73 and p=0.0127.
    • Response: ORR was 60.3% versus 45.5%, median DoR was 16.6 months versus 8.2 months, and OS showed a favorable trend with HR=0.76.
  • SHR-A2102-303: In perioperative MIBC, SHR-A2102 plus adebrelimab showed pCR of 48.1% among 27 evaluable patients undergoing radical cystectomy.
    • Additional efficacy: In patients with measurable lesions, ORR was 71.4% and DCR was 100%; Hengrui plans to initiate the Phase III stage of the study.

Kelun-Biotech’s (6990.HK) B7-H3 ADC SKB500 Shows Broad Solid Tumor Activity at ASCO 2026

Key Words: Kelun-Biotech, SKB500, B7-H3 ADC, OptiDC, ASCO 2026, SCLC, ESCC, solid tumors, topoisomerase I inhibitor

• The News: Kelun-Biotech presented first-in-human Phase I data of SKB500, its B7-H3-targeted ADC, in advanced solid tumors at ASCO 2026. SKB500 showed broad antitumor activity across multiple tumor types, with particularly strong efficacy signals in small cell lung cancer.
• Key Highlights:
• Clinical Data:
  • Study Design: Phase I study included dose escalation, dose expansion and indication expansion, enrolling 192 patients with advanced solid tumors including SCLC, ESCC, HNSCC, CRC, NEC and other tumors.
  • Dosing: Patients received SKB500 at 2-18mg/kg Q3W, with dose and indication expansion mainly conducted at 12mg/kg and 16mg/kg.
  • Overall Efficacy: Among 124 patients treated at 12mg/kg with ≥6 weeks of follow-up, ORR was 42.7% and DCR was 83.9%.
  • Safety: The 12mg/kg dose showed a more favorable safety profile than 16mg/kg, with Grade ≥3 TRAEs of 32.3%, mainly hematologic events; no treatment-related deaths were reported.
• Drug Profile – SKB500.
  • SKB500: A B7-H3-targeted ADC developed using Kelun-Biotech’s OptiDC platform, carrying a topoisomerase I inhibitor payload.
  • Target / Indication: Targeted B7-H3, with clinical activity observed in SCLC, ESCC, HNSCC, PDAC, NSCLC and NPC; a Phase II exploratory study in extensive-stage SCLC is ongoing in China.
  • Mechanism: Designed to bind B7-H3-expressing tumor cells, undergo internalization and release a topoisomerase I inhibitor payload to induce DNA damage and tumor cell death.
  • Development Status: A Phase II exploratory study of SKB500 in combination with immunotherapy with or without chemotherapy as first-line treatment for extensive-stage SCLC is ongoing in China.

Biokin’s (688506.SH) ADC and Bispecific Pipeline Shows Multiple Positive Readouts at ASCO 2026

Key Words: Biokin, ASCO 2026, iza-bren, izalontamab, T-Bren, BL-M14D1, bispecific ADC, HER2 ADC, DLL3 ADC, ESCC, HNSCC, breast cancer, ovarian cancer, SCLC

• The News: Biokin Pharmaceutical presented multiple oncology clinical updates at ASCO 2026, covering its bispecific ADC, HER2 ADC, EGFR×HER3 bispecific antibody and DLL3 ADC programs. Key readouts included positive Phase III data for iza-bren in second-line ESCC, Phase II activity for T-Bren in HER2-positive breast cancer and ovarian cancer, and early efficacy signals for BL-M14D1 in SCLC and NEC.
• Key Highlights:
• Clinical Data:
  • PANKU-Esophagus01: In second-line ESCC, iza-bren met dual primary endpoints versus chemotherapy, with median PFS of 4.17 months vs. 1.97 months, HR=0.50, and median OS of 9.79 months vs. 7.20 months, HR=0.64.
    • ESCC response: ORR was 35.3% for iza-bren versus 13.1% for chemotherapy; safety was manageable.
  • Izalontamab + Paclitaxel: In 34 evaluable pre-treated R/M HNSCC patients who progressed after anti-PD-(L)1 therapy, ORR was 52.9%, DCR was 73.5%, median PFS was 5.4 months and median OS was 11.2 months.
  • T-Bren + Pertuzumab: In first-line HER2-positive breast cancer, T-Bren plus pertuzumab showed confirmed ORR of 87.5%, 1-year PFS rate of 90.8% and 1-year OS rate of 95%, with no treatment-related ILD observed.
  • BL-M14D1: In second-line SCLC at 4.0mg/kg, BL-M14D1 showed median PFS of 8.1 months and confirmed ORR of 71.4%; in late-line NEC at 4.5mg/kg, 6-month PFS rate was 67.1% and confirmed ORR was 38.7%.
  • T-Bren in PROC: In HER2-expressing platinum-resistant recurrent ovarian cancer, T-Bren achieved confirmed ORR of 52.5%, 9-month PFS rate of 54.7% and target lesion shrinkage rate of 83.7%; median PFS was not reached.
• Drug Profile:
  • Iza-bren: A bispecific ADC being developed for relapsed / metastatic ESCC after anti-PD-(L)1 treatment, with Phase III PANKU-Esophagus01 showing PFS and OS benefit versus chemotherapy.
  • Izalontamab: An EGFR×HER3 bispecific antibody being evaluated with paclitaxel for recurrent / metastatic HNSCC after anti-PD-(L)1 therapy.
  • T-Bren: A HER2-targeted ADC being developed across HER2-expressing tumors, including first-line HER2-positive breast cancer and HER2-expressing platinum-resistant ovarian cancer.
  • BL-M14D1: A DLL3-targeted ADC being developed for SCLC and neuroendocrine carcinoma, with Phase III registrational studies planned.

RemeGen’s (9995.HK) Disitamab Vedotin Shows Broad HER2-Targeted Activity Across Tumors at ASCO 2026

Key Words: RemeGen, disitamab vedotin, RC48, ASCO 2026, HER2 ADC, breast cancer, gastric cancer, cervical cancer, ovarian cancer, urothelial cancer, penile cancer

• The News: RemeGen presented multiple ASCO 2026 studies of disitamab vedotin across breast cancer, gynecologic tumors, gastric cancer and urological tumors. The data support continued expansion of RC48-based HER2-targeted regimens across early-stage, advanced and perioperative treatment settings.
• Key Highlights:
• Clinical Data:
  • Breast Cancer: RC48 plus toripalimab and carboplatin achieved total pCR of 62.5% and ORR of 92.5%. In advanced breast cancer, real-world data showed median PFS of 11.01 months with RC48 sequential ADC therapy.
  • Gynecologic Tumors: RC48 plus cadonilimab achieved ORR of 51.7% and median OS of 27.0 months. In advanced ovarian cancer, RC48 plus carboplatin achieved a complete resection rate of 91.6% as neoadjuvant therapy.
  • Gastric Cancer: RC48-based regimens showed confirmed ORR of 75.0% in HER2 medium-low patients, with PFS HR of 0.55 and OS HR of 0.61. In HER2-high patients, RC48-based therapy showed PFS HR of 0.58 and OS HR of 0.42.
• Product Profile – Disitamab Vedotin / RC48:
  • Disitamab Vedotin / RC48: A HER2-targeted ADC approved in China and being developed across multiple HER2-expressing solid tumors
  • Mechanism: Designed to bind HER2-expressing tumor cells, undergo internalization and release a cytotoxic payload to induce tumor cell killing, including in tumors with lower HER2 expression.
  • Indication Focus: HER2-expressing gastric cancer, urothelial cancer, breast cancer, cervical cancer, ovarian cancer and other solid tumors.
  • Development Stage: Multiple Phase II and Phase II/III studies are ongoing, including RC48-C040 to further evaluate chemotherapy-free regimens in gastric cancer.

Henlius’(2696.HK) Serplulimab Shows EFS Benefit in Perioperative Gastric Cancer at ASCO 2026

Key Words: Henlius, serplulimab, HANSIZHUANG, PD-1 antibody, ASCO 2026, gastric cancer, GEJ adenocarcinoma, perioperative therapy, ASTRUM-006

• The News: Henlius presented Phase III ASTRUM-006 data for serplulimab in PD-L1-positive resectable gastric / GEJ adenocarcinoma at ASCO 2026, with simultaneous publication in The Lancet. The study met its primary endpoint, showing significant EFS improvement for neoadjuvant serplulimab plus SOX followed by adjuvant serplulimab monotherapy versus perioperative chemotherapy.
• Key Highlights:
• Clinical Data:
  • Study Design: Phase III ASTRUM-006 enrolled 588 previously untreated, resectable gastric / GEJ adenocarcinoma patients with PD-L1 CPS ≥5 across 57 centers in China.
  • Primary Endpoint: Investigator-assessed median EFS was not reached with serplulimab versus 35.9 months for control, with HR of 0.73 and p=0.015.
  • BICR-assessed EFS: Median EFS was not reached versus 52.0 months, with HR of 0.67 and p=0.0061.
  • Pathological Response: pCR rate was 21.6% with serplulimab versus 6.4% for control.
  • Safety: Grade ≥3 TRAEs were 46.6% versus 58.5%, and TRAE-related discontinuation rates were 6.5% versus 10.5% for serplulimab and control, respectively.
• Product Profile – Serplulimab:
  • Serplulimab / HANSIZHUANG: An anti-PD-1 monoclonal antibody being developed as perioperative therapy for PD-L1-positive resectable gastric / GEJ adenocarcinoma.
  • Mechanism: Designed to block PD-1 signaling and restore T-cell-mediated antitumor immune activity.
  • Indication Focus: PD-L1-positive resectable gastric / GEJ adenocarcinoma in the perioperative setting; serplulimab is also approved across multiple lung and gastrointestinal cancer indications.
  • Regulatory Staus: Received CDE Breakthrough Therapy Designation in perioperative gastric cancer in November 2025; NDA accepted with Priority Review in December 2025.

Lupeng Pharma’s Rocbrutinib Approved in China for BTK Inhibitor-Pretreated Mantle Cell Lymphoma

Key Words: Lupeng Pharma, rocbrutinib, LP-168, BTK inhibitor, fourth-generation BTK inhibitor, mantle cell lymphoma, MCL, NMPA approval

• The News: Lupeng Pharma received NMPA approval for rocbrutinib tablets, its fourth-generation BTK inhibitor, for adults with mantle cell lymphoma who previously received BTK inhibitor treatment. Rocbrutinib is the first approved fourth-generation BTK inhibitor globally.
• Key Highlights:
• Clinical Data:
  • Study Design: Approval was supported by the Phase II ROCK-1 study in previously treated mantle cell lymphoma patients.
  • Efficacy: Rocbrutinib achieved an ORR of 63.9%, with CR rate of 23.0%.
  • PFS: Median PFS was 7.39 months.
  • Durability: At a median follow-up of 11.27 months, median DoR was 16.46 months, with estimated 12-month DoR rate of 61.2%.
• Product Profile – Rocbrutinib / LP-168:
  • Rocbrutinib / LP-168: A fourth-generation BTK inhibitor with dual covalent and non-covalent binding activity, approved in China for BTK inhibitor-pretreated adult mantle cell lymphoma.
  • Mechanism: Designed to inhibit BTK through both covalent and non-covalent binding, aiming to overcome resistance associated with earlier-generation BTK inhibitors.
  • Regulatory Status: Included in China CDE Breakthrough Therapy Designation list in May 2024 and approved by NMPA in June 2026.
• Lupeng Pharma is a clinical-stage biotech focused on oral small-molecule therapies for oncology and autoimmune diseases.

CSPC’s (1093.HK) mRNA-LNP Dual-Target CAR-T SYS6063 Cleared for Clinical Trial in China

Key Words: CSPC, SYS6063, mRNA-LNP, in vivo CAR-T, CD19, BCMA, systemic lupus erythematosus, autoimmune diseases

• The News: CSPC Pharmaceutical Group received clinical trial clearance in China for SYS6063, an mRNA-LNP-based dual-target CAR-T therapy targeting CD19 and BCMA. The initial indication is relapsed or refractory systemic lupus erythematosus.
• Key Highlights:
• China CTA Clearance: SYS6063 has been cleared to enter human clinical trials in China.
• CSPC plans to explore SYS6063 in other B-cell-mediated autoimmune diseases, including myasthenia gravis and rheumatoid arthritis.
• Product Profile – SYS6063:
  • SYS6063: An mRNA-LNP-based dual-target CAR-T therapy designed to simultaneously target CD19-positive B cells and BCMA-positive plasma cells.
  • Mechanism: Uses lipid nanoparticle delivery of mRNA to generate CAR-T activity in vivo, aiming to eliminate pathogenic B cells and plasma cells without conventional ex vivo CAR-T manufacturing.
  • Indication Focus: Relapsed / refractory SLE, with potential expansion into other B-cell-mediated autoimmune diseases and hematologic malignancies.
  • Preclinical Data: Showed cytotoxic activity against CD19- and BCMA-positive cells, with a favorable preclinical safety profile.
  • Mechanism: Designed to bind cereblon and promote degradation of transcription factors Ikaros and Aiolos, enhancing anti-myeloma activity and immune-mediated tumor killing.
  • Regulatory Status: Recommended for Priority Review in China for mezigdomide plus carfilzomib and dexamethasone.

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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