This week’s key updates in China’s healthcare sector include Laekna’s US$500M licensing deal with Vasque Bio for PI3Kα inhibitor LAE118, LongBio’s HK$1.25B IPO with its anti-IgE antibody nearing BLA, and Kelun-Biotech’s RMB 700M settlement tied to YL201 licensing. On the clinical side, RemeGen’s telitacicept became the first approved biologic for Sjögren’s syndrome, Gracell’s dual-target CAR-T advanced with AstraZeneca, and Shouyao’s RET inhibitor showed 90% ORR in NSCLC Phase III trials. These milestones underscore China’s innovation and global impact in biotech.

Transactions & BD (In/Out Licensing)

Laekna (2105.HK) Licenses PI3Kα Pan-Mutation Selective Inhibitor LAE118 to Vasque Bio in Deal Worth Over US$ 500 Million

Key Words: Laekna, Vasque Bio, LAE118, PI3Kα inhibitor, PIK3CA-mutant solid tumors, global license, oncology, NewCo

• The News: Laekna entered into an exclusive licensing agreement with Vasque Bio for LAE118, its internally developed PI3Kα pan-mutation selective inhibitor. Vasque Bio will receive exclusive global rights outside mainland China, Hong Kong, Macau and Taiwan to develop, manufacture and commercialize LAE118.
• Key Highlights:
• Deal Details:
  • Upfront Payment: Up to US$ 10 millio
  • Milestone Payments: Up to US$ 517 million.
  • Rights Granted: Exclusive development, manufacturing and commercialization rights to LAE118 in the licensed territory.
• Drug Profile – LAE118:
  • LAE118: A novel PI3Kα pan-mutation selective inhibitor developed by Laekna for PIK3CA-mutant solid tumors.
  • Mechanism: Designed to selectively inhibit mutant PI3Kα signaling, a key oncogenic pathway in PIK3CA-mutant tumors, while aiming to improve selectivity versus wild-type PI3Kα.
  • Indication Focus: PIK3CA-mutant solid tumors.
  • Development Stage: IND approved in the U.S. and China; Laekna is advancing the candidate toward clinical studies.

LongBio Pharma (1779.HK) Lists on HKEX with Anti-IgE Antibody LP-003 Nearing BLA Filing

Key Words: LongBio Pharma, HKEX IPO, LP-003, anti-IgE antibody, allergic rhinitis, chronic spontaneous urticaria, LP-005, complement inhibitor

• The News: LongBio Pharma listed on the Hong Kong Stock Exchange on June 5, 2026. The company priced its IPO at HK$ 96.06 per share and raised approximately HK$ 1.25 billion in net proceeds. Its core product LP-003 has completed a Phase III study in seasonal allergic rhinitis, with BLA submission in China planned in 2026.
• Key Highlights:
• Deal Details:
  • Listing Date: June 5, 2026.
  • Offer Price: HK$ 06 per H share.
  • Net Proceeds: Approximately HK$ 25 billion.
• Core Product – LP-003:
  • LP-003: A next-generation anti-IgE antibody being developed for allergic diseases.
  • Indication Focus: Seasonal allergic rhinitis, chronic spontaneous urticaria, allergic asthma and other IgE-mediated conditions.
  • Mechanism: Designed to block free IgE in blood and tissues, thereby inhibiting IgE-mediated allergic responses.
  • Clinical Development: LP-003 has completed a Phase III study in seasonal allergic rhinitis, with China BLA submission planned in 2026.
  • Clinical Data: In a head-to-head Phase II study in chronic spontaneous urticaria, the high-dose LP-003 group showed a 66.7% complete symptom control rate at Week 12, outperforming omalizumab in the reported comparison.

WestGene Biopharma Partners with Cartesian Therapeutics (RNAC.O) to Develop in vivo CAR-T and TCE Therapies for Autoimmune Diseases

Key Words: WestGene Biopharma, Cartesian Therapeutics, in vivo CAR-T, TCE, mRNA, targeted LNP, autoimmune diseases, BCMA, generalized myasthenia gravis

• The News: WestGene Biopharma entered into a strategic collaboration and licensing agreement with Cartesian Therapeutics to jointly develop mRNA- and targeted LNP-based in vivo CAR-T and T-cell engager therapies for autoimmune diseases. Under the agreement, Cartesian will gain access to WestGene’s targeted LNP platform, while WestGene will lead early-stage research and development.
• Key Highlights:
• Deal Details:
  • First program: The initial collaboration program will focus on a BCMA-targeted in vivo CAR-T therapy for generalized myasthenia gravis.
  • WestGene will primarily lead early research and development, while Cartesian will be responsible for later-stage global clinical development and commercialization.
• Platform Profile – mRNA / targeted LNP in vivo Cell Therapy Platform:
  • WestGene’s LNP / tLNP platform: A proprietary mRNA delivery platform designed to deliver therapeutic mRNA to selected immune cell population
  • Mechanism: Instead of isolating and engineering patient T cells ex vivo, the platform aims to deliver CAR or TCE-encoding mRNA directly into the body, enabling immune cells to be transiently reprogrammed in vivo.
• WestGene Biopharma is a clinical-stage biotech focused on LNP / targeted LNP delivery technologies and mRNA medicines across oncology, autoimmune diseases, infectious diseases and in vivo cell therapy.

Neuracle Files STAR Market IPO with RMB 4 Billion Post-Money Valuation

Key Words: Neuracle, STAR Market IPO, brain-computer interface, BCI, invasive BCI, medical device, NEO system

• The News: Brain-computer interface company Neuracle filed for a STAR Market IPO, with its application accepted on June 11, 2026. The company plans to issue no more than 20 million shares, representing no more than 25% of its post-IPO share capital, and aims to raise RMB 2.5 billion.
• Key Highlights:
• Deal Details:
  • Planned Fundraising: RMB 5 billion
  • Latest Financing: Completed a RMB 300 million financing round in November 2025, with post-money valuation of RMB 4
  • Share Issuance: No more than 20 million shares, representing no more than 25% of post-IPO share capital.
  • Use of Proceeds: RMB 54 billion for BCI R&D projects, RMB 410 million for BCI industrialization construction, RMB 174 million for production capacity build-out, RMB 236 million for marketing network and digital infrastructure, and RMB 550 million for working capital.
• Financial Profile:
  • 2023 Revenue: RMB 75.21 million.
  • 2024 Revenue: RMB 65.97 million.
  • 2025 Revenue: RMB 108.48 million.
• Neuracle is a high-tech company specializing in brain-computer interface technologies and related medical devices, with a product portfolio spanning invasive and non-invasive BCI applications.

Kelun-Biotech (6990.HK) Receives Over RMB 700 Million Settlement Payment from MediLink Therapeutics

Key Words: Kelun-Biotech, MediLink Therapeutics, settlement, YL201, B7-H3 ADC, licensing revenue sharing, intellectual property dispute

• The News: Kelun-Biotech announced that it has received RMB 602.5 million from MediLink Therapeutics under a previously reached settlement agreement, representing Kelun-Biotech’s share of income related to MediLink’s out-licensing of YL201. As of the announcement date, Kelun-Biotech has received a total of RMB 702.7 million from MediLink under the settlement.
• Key Highlights:
• Deal Detail:
  • Latest Payment: RMB 602.5 million related to YL201 out-licensing income sharing.
  • Total Payments Received in 2026: RMB 702.7 million as of the announcement date.
  • Covered Assets: YL201 (B7-H3), YL202 (HER3), YL211 (c-Met), YL212 (DLL3), YL221 (EGFR), and YL222 (PD-L1).
• Product Profile – YL201:
  • YL201: A B7-H3-targeted antibody-drug conjugate developed by MediLink Therapeutics.
  • Mechanism: Designed to target B7-H3-expressing tumor cells and deliver a cytotoxic payload through ADC-mediated internalization.
  • Indication Focus: Advanced solid tumors with B7-H3 expression, positioning it as a broad-spectrum ADC candidate across multiple oncology indications.
• Background and Dispute Resolution: The payments stem from the settlement of civil and criminal disputes between Kelun-Biotech and MediLink Therapeutics in late 2025. These disputes involved allegations of trade secret misappropriation. As part of the resolution, both parties agreed to a profit and income-sharing arrangement, which underpins the over RMB 700 million received to date by Kelun-Biotech.

Simcere (2096.HK) Partners with Puqi Pharma to Promote Pumecitinib Gel in Dermatology Indications

Key Words: Simcere, Puqi Pharma, pumecitinib gel, JAK inhibitor, atopic dermatitis, dermatology, autoimmune disease, exclusive promotion

• The News: Simcere Pharmaceutical entered into an exclusive promotion service agreement with Puqi Pharma for pumecitinib gel, a topical JAK inhibitor for dermatology indications. Under the agreement, Simcere will obtain exclusive promotion rights for pumecitinib gel across all dermatology indications in mainland China, Hong Kong and Macau.
• Key Highlights:
• Regulatory Status: NDA accepted by China CDE for adult and adolescent atopic dermatitis.
• Drug Profile – Pumecitinib Gel:
  • Pumecitinib Gel: A topical JAK inhibitor gel being developed for inflammatory dermatologic diseases.
  • Mechanism: Designed to inhibit JAK-mediated inflammatory signaling locally in skin lesions, reducing inflammatory responses while limiting systemic exposure.
  • Indication focus: Mild-to-moderate atopic dermatitis in adults and adolescents aged 12 years and above, with further development planned in pediatric atopic dermatitis, prurigo nodularis and non-segmental vitiligo.
• Puqi Pharma is a China-based biotech focused on local delivery of targeted therapies for chronic inflammatory diseases, aiming to balance efficacy, safety and long-term patient convenience.

Boan Biotech (6955.HK) Licenses U.S. Commercial Rights to Dulaglutide Biosimilar BA5101

Key Words: Boan Biotech, BA5101, dulaglutide, GLP-1 receptor agonist, Trulicity biosimilar, type 2 diabetes, U.S. commercialization, biosimilar licensing

• The News: Boan Biotech entered into a licensing agreement for the U.S. market rights to BA5101, its dulaglutide injection biosimilar. Under the agreement, the undisclosed partner will be responsible for U.S. commercialization, including regulatory submission and sales.
• Key Highlights:
• Rights Granted: U.S. commercialization rights, including regulatory filing and sales.
• Economics: Boan Biotech will receive upfront payment, milestone payments and royalties on future sales.
• Drug Profile – BA5101:
  • BA5101: A dulaglutide biosimilar developed by Boan Biotech for type 2 diabetes, approved in China in August 2025.
  • Mechanism: Designed to activate GLP-1 receptors, improving glucose-dependent insulin secretion, stabilizing blood glucose and reducing HbA1c levels.
  • Biosimilar evidence: Developed under China, U.S. and EU biosimilar guidelines, with comparability demonstrated through quality, non-clinical, pharmacokinetic, efficacy, safety and immunogenicity studies.

Lanacheng Biotech Files for Hong Kong IPO with RMB 3.29 Billion Post-Money Valuation

Key Words: Lanacheng Biotech, Hong Kong IPO, radiopharmaceuticals, PSMA, FAP, αvβ3, oncology diagnostics, radioligand therapy

• The News: Lanacheng Biotech filed for a Hong Kong IPO, with its application accepted on June 13, 2026. The company is focused on the discovery, development and commercialization of oncology radiopharmaceuticals, with a pipeline covering both diagnostic and therapeutic nuclear medicine products.
• Key Highlights:
• IPO Details:
  • Filing Date: June 13, 2026.
  • Latest Financing: RMB 490 million Series C financing completed in July 2025.
  • Latest Post-money Valuation: RMB 29 billion.
• Core Product Areas:
  • PSMA Radiopharmaceuticals: Diagnostic and therapeutic programs targeting prostate-specific membrane antigen, primarily focused on prostate cancer.
  • FAP Radiopharmaceuticals: Diagnostic programs targeting fibroblast activation protein, including gastric cancer-related applications.
  • FAP / αvβ3 Radiopharmaceuticals: Dual-target diagnostic program focused on renal cancer imaging.
• Pipeline Composition: built a 13-asset pipeline, including seven diagnostic radiopharmaceuticals and six therapeutic radiopharmaceuticals.
• Lanacheng Biotech is a radiopharmaceutical biotech established in 2021, focused on oncology nuclear medicine products spanning diagnosis, treatment and potential theranostic applications.

Clinical

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.

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 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.

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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