This week’s China healthcare highlights include Kailera’s US$ 625M Nasdaq debut, driven by its GLP-1/GIP dual agonist KAI-9531 for obesity; Haisco’s US$ 745M licensing deal with AbbVie to develop its Nav1.8 inhibitors for pain treatment; and Bio-Thera’s RMB 450M asset transfer of CVD drug Betagrin to Lepu Pharma. Aligos partnered with Amoytop in a US$ 445M licensing deal to advance HBV therapy, while Bayer’s HER2 inhibitor sevabertinib gained China approval for NSCLC. Additionally, Hansoh and Hengrui secured Breakthrough Therapy Designations for ADCs targeting NSCLC and cervical cancer, respectively, and LEO Pharma expanded its psoriasis portfolio with Enstilar® approval. These developments highlight robust activity across IPOs, licensing, and oncology innovation in China.

Transactions

Kailera (KLRA.O) Soars Over 60% in Nasdaq Debut as Weight-Loss Drug Race Heats Up

Key Words: Kailera, IPO, Nasdaq, GLP-1, ribupatide, weight-loss drugs, obesity, HRS9531, KAI-9531, KAI-7535, biotech IPO

• The News: On April 17, 2026, Kailera Therapeutics (Nasdaq: KLRA), a spin-off of Jiangsu Hengrui Pharmaceuticals, debuted on the Nasdaq Stock Exchange, raising US$ 625 million in gross proceeds from its initial public offering (IPO), excluding underwriters’ overallotment options and related expenses. The company sold approximately 39 million shares at $16 per share, the top of its marketed range. The stock opened trading at $26, soaring over 60% on its first day, reflecting strong investor interest in the booming weight-loss drug market.
• Key Highlights:
• KAI-9531 (HRS9531): A GLP-1/GIP dual receptor agonist available as both injectable (once-weekly) and oral formulations.
  • Currently in Phase III global clinical trials for the treatment of obesity (outside Greater China).
  • NDA submitted and accepted in China for long-term weight management in adults.
• KAI-7535 (HRS-7535): An oral small-molecule GLP-1 receptor agonist in clinical development.
• KAI-4729 (HRS-4729): A GLP-1/GIP/GCG triple receptor agonist under development.
• IPO Details:
  • Shares sold: Roughly 39 million.
  • Pricing: US$ 16 per share, the top of the marketed range.
  • Opening price: US$ 26 per share on Nasdaq, up over 60%.

Haisco (002653.SZ) Licenses 2 Nav1.8 Inhibitors to AbbVie in Deal Worth up to US$ 745m

Key Words: Haisco, AbbVie, Nav1.8 inhibitors, HSK55718, HSK51155, pain treatment, licensing deal, milestone payments

• The News: Haisco Pharmaceutical has signed an exclusive global licensing agreement with AbbVie for its Nav1.8 inhibitor program, which includes HSK55718 and HSK51155. The agreement grants AbbVie the exclusive rights to develop, manufacture, and commercialise the candidates outside Mainland China, Hong Kong, and Macau. Haisco will receive an upfront payment of US$ 30 million and could earn up to US$ 715 million in development and commercial milestone payments, along with tiered royalties of up to the mid-single-digit percentage range on future net sales.
• Key Highlights:
• 8 Inhibitor Program:
  • HSK55718: An intravenous formulation currently in Phase I clinical trials in China.
  • HSK51155: An oral candidate in preclinical development.
  • Both candidates are selective blockers of the Nav1.8 sodium channel, designed to inhibit abnormal pain signal transmission for pain-related conditions.
• Deal Terms:
  • Upfront payment: US$ 30 million.
  • Additional milestones: Up to US$ 715 million based on development and commercial achievements.
  • Royalties: Tiered, up to mid-single-digit percentage on future net sales.

Bio-Thera (688177.SS) to Transfer CVD Drug to Lepu Pharma for RMB 450m

Key Words: Bio-Thera, Lepu Pharma, Betagrin, bevifibatide, CVD, PCI, GPIIb/IIIa, MAH transfer, royalties

• The News: Bio-Thera Solutions has signed an agreement to transfer the rights and associated assets for its cardiovascular disease (CVD) drug, Betagrin (bevifibatide), to Lepu Pharmaceuticals for a total consideration of RMB 450 million (US$ 63 million). Betagrin, a GPIIb/IIIa receptor antagonist, was approved in China in June 2024 to prevent acute occlusion, stent thrombosis, and other complications in acute coronary syndrome patients undergoing percutaneous coronary intervention (PCI).
• Key Highlights:
• Betagrin (Bevifibatide):
  • A GPIIb/IIIa receptor antagonist approved to reduce PCI-related complications in CVD patients.
  • Approved in China in June 2024.
• Transaction Terms:
  • RMB 450 million payment will be made in five instalments, with the final tranche tied to the completion of the MAH and production technology transfers.
  • Bio-Thera will receive single-digit percentage royalties on Betagrin’s net sales for up to 10 years.

Aligos Therapeutics (ALGS.O) Enters into Exclusive License Deal with Xiamen Amoytop Biotech to Develop and Commercialize Pevifoscorvir Sodium in Greater China for Chronic Hepatitis B Virus Infection

Key Words: Aligos Therapeutics, Xiamen Amoytop, exclusive license, pevifoscorvir sodium, chronic HBV infection, Greater China, biotech collaboration

• The News: Aligos Therapeutics, a clinical-stage biopharmaceutical company, announced an exclusive licensing agreement with Xiamen Amoytop Biotech (Amoytop). The partnership enables Amoytop to develop and commercialize pevifoscorvir sodium in Greater China, encompassing Mainland China, Taiwan, Hong Kong, and Macau, for chronic hepatitis B virus (HBV) infection. The agreement supports Aligos’s goal of addressing major unmet needs in HBV therapy while leveraging Amoytop’s market leadership and capabilities in the region.
• Key Highlights:
• Upfront Payment: Aligos will receive US$ 25 million USD upfront.
• Milestones & Royalties: Aligos is eligible for up to US$ 420 million USD in clinical, regulatory, and sales milestones, alongside tiered, high single-digit royalties on net sales.
• Development Roles: Amoytop will fully fund the program in Greater China, while Aligos retains development and commercialization rights for pevifoscorvir sodium in the US, Europe, Japan, and additional markets.
• About pevifoscorvir sodium:
  • Mechanism of Action: Oral small molecule CAM-E that blocks HBV replication, prevents HBV DNA integration, and reduces cccDNA.
  • Clinical Data: Phase 1 studies confirmed pevifoscorvir sodium is well-tolerated with linear pharmacokinetics and promising antiviral efficacy.
  • Regulatory pathways acknowledged by the FDA, EMA, and NMPA (China).
  • Pipeline Expansion: Pevifoscorvir sodium is being evaluated in the Phase 2 B-SUPREME clinical trial (NCT06963710), with interim data expected in late 2026 and topline results in 2027.
• About Amoytop: Amoytop is a leading biopharma company in China, specializing in recombinant protein drugs and immune-related therapies, with a strong focus on viral hepatitis and cytokine medicine development.

Clinical

Bayer’s (ETR: BAYN) First-in-Class HER2 Inhibitor Approved in China for NSCLC

Key Words: Bayer, sevabertinib, BAY 2927088, HER2, tyrosine kinase inhibitor, NSCLC, China, SOHO-01 study, oncology, drug approval

• The News: Bayer received marketing authorization in China for sevabertinib (BAY 2927088), a first-in-class HER2 inhibitor for adults with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2)-activating mutations who have received prior systemic therapy. Sevabertinib is an oral, reversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations, including HER2 exon 20 insertions.
• Key Highlights:
• Sevabertinib (BAY 2927088):
  • An oral tyrosine kinase inhibitor developed by Bayer for tumors characterized by EGFR and HER2 mutations.
  • Targets HER2 exon 20 insertions, offering a novel treatment avenue for patients with HER2-driven NSCLC.
• Clinical Data – SOHO-01 Trial:
  • Objective Response Rate (ORR): 64% in HER2 inhibitor-naive patients.
  • Median Progression-Free Survival (PFS): 8.3 months in previously treated patients.
  • Demonstrated efficacy even in patients who had previously received HER2-targeted therapies, including antibody-drug conjugates (ADCs).
• Bayer has filed an additional new drug application (NDA) in China for the first-line treatment of HER2-mutant NSCLC.

Roche (SWX: ROP) Files Oral SERD Giredestrant in China

Key Words: Roche, Giredestrant, SERD, breast cancer, ESR1 mutations, endocrine therapy, evERA trial, NDA

• The News: Roche announced the submission of a new drug application (NDA) in China for giredestrant, an oral selective estrogen receptor degrader (SERD), in combination with everolimus. The application targets postmenopausal women and men with ESR1-mutated, ER+/HER2- locally advanced or metastatic breast cancer who have progressed on prior endocrine therapy. The submission follows a similar application in the U.S. filed in February 2026.
• Key Highlights:
• Giredestrant: An oral SERD designed to block and degrade the estrogen receptor to inhibit cancer growth.
• Clinical Data:
  • Results from the Phase III evERA trial showed significant improvement in progression-free survival (PFS) for the giredestrant + everolimus combination compared to the control arm.
  • The PFS benefit was more pronounced in patients with ESR1 mutations.
• Trial Outcomes:
  • Giredestrant did not meet the primary endpoint in the first-line persevERA trial.
  • The candidate succeeded in an adjuvant setting study (lidERA).

Laekna’s (2105.HK) Afuresertib Succeeds in Phase III Trial for HR+/HER2- Breast Cancer

Key Words: Laekna, Afuresertib, AKT inhibitor, HR+/HER2-, breast cancer, AFFIRM-205, PIK3CA, AKT1, PTEN, CDE, NDA

• The News: Laekna Therapeutics announced that its pan-AKT inhibitor, afuresertib (LAE002), met the primary endpoint in the Phase III AFFIRM-205 trial for hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer. The trial demonstrated that afuresertib, in combination with fulvestrant, significantly improved progression-free survival (PFS) compared to fulvestrant plus placebo in patients with PIK3CA/AKT1/PTEN alterations whose disease had progressed on prior endocrine therapy.
• Key Highlights:
• Afuresertib:
  • A pan-AKT inhibitor initially acquired from Novartis.
  • One of only two AKT inhibitors completing late-stage oncology development globally.
• Clinical Data:
  • The AFFIRM-205 trial demonstrated a median PFS of 7.6 months for afuresertib + fulvestrant versus 2.0 months for fulvestrant plus placebo.
  • Significant efficacy was observed in patients with PIK3CA/AKT1/PTEN genetic alterations.
  • The drug was well-tolerated, with a low discontinuation rate due to adverse events.
• Next Steps:
  • Laekna and its partner Qilu Pharmaceutical plan to submit a new drug application (NDA) to China’s Centre for Drug Evaluation (CDE).
  • Laekna intends to pursue global partnerships for afuresertib’s development outside of China.

LEO Pharma (LEOW.F) Expands Psoriasis Portfolio in China with NMPA Approval of Enstilar®

Key Words: LEO Pharma, Enstilar, plaque psoriasis, NMPA approval, China, calcipotriene, betamethasone, dermatology

• The News: LEO Pharma has received approval from China’s National Medical Products Administration (NMPA) for Enstilar® (calcipotriene/betamethasone dipropionate), a foam-based treatment for adult patients with plaque psoriasis. The new approval provides an additional option for the estimated 6.5 million individuals in China affected by the condition, solidifying LEO Pharma’s position as a leader in dermatology and expanding its footprint in the largest psoriasis market globally, measured by patient numbers.
• Key Highlights:
• Enstilar (Calcipotriene/Betamethasone):
  • A foam formulation designed for easy application, including use on hair-bearing areas, ensuring even distribution and rapid relief as observed in clinical studies.
  • Approved in more than 50 markets globally, Enstilar has established itself as a leading topical psoriasis treatment.
• Clinical Data Supporting NMPA Approval:
  • A Phase III trial involving 604 adult patients in China demonstrated the superiority of Enstilar to Daivobet® (calcipotriene/betamethasone) ointment, achieving both primary and secondary endpoints after 4 weeks of treatment.
  • Results confirmed favorable efficacy and safety profiles, further substantiating Enstilar as an innovative treatment for plaque psoriasis in China.

Hansoh’s (3692.HK) HS-20093 in Combination with Adebrelimab Receives Breakthrough Therapy Designation from NMPA

Key Words: Hansoh, HS-20093, adebrelimab, NMPA, Breakthrough Therapy Designation, NSCLC, ADC, B7-H3

• The News: Hansoh Pharmaceutical announced that its self-developed B7-H3 targeted antibody-drug conjugate (ADC), HS-20093, in combination with adebrelimab, has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration (NMPA). This designation covers the proposed treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with driver gene negativity in patients who have progressed or relapsed after prior platinum-containing chemotherapy.
• Key Highlights:
• HS-20093 and Adebrelimab Combination Therapy:
  • HS-20093 is a B7-H3 targeted ADC developed by Hansoh.
  • Adebrelimab is a PD-L1 inhibitor, which, in combination with HS-20093, aims to enhance anti-tumor activity.
• Proposed Indication:
  • Locally advanced or metastatic non-squamous NSCLC without driver mutations.
  • Target patient population includes those who have relapsed or progressed after prior platinum-containing chemotherapy.
• Regulatory Milestone:
  • Breakthrough Therapy Designation provides an expedited pathway for HS-20093’s development and potential approval.
  • The designation underscores the therapy’s potential to address unmet medical needs in a difficult-to-treat patient group.

Hengrui’s (1276.HK, 600276.SS) SHR-A2102 Receives Breakthrough Therapy Designation for Recurrent or Metastatic Cervical Cancer

Key Words: Hengrui, SHR-A2102, ADC, Breakthrough Therapy Designation, cervical cancer, Nectin-4, CDE

• The News: Hengrui announced that its antibody-drug conjugate (ADC), SHR-A2102, has received Breakthrough Therapy Designation from China’s Center for Drug Evaluation (CDE) for the treatment of recurrent or metastatic cervical cancer following failure of platinum-based chemotherapy and PD-(L)1 inhibitors. This recognition marks SHR-A2102’s second Breakthrough Therapy Designation and underscores its potential to address critical unmet medical needs across multiple cancer types.
• Key Highlights:
• Indication and Unmet Need:
  • Patients with recurrent or metastatic cervical cancer have limited treatment options after failure of standard chemotherapy and PD-(L)1 inhibitors.
  • Currently available single-agent chemotherapy provides response rates below 10%, a median progression-free survival (PFS) of approximately 3 months, and a median overall survival (OS) of 8.5–9.5 months.
• SHR-A2102 Overview:
  • A Nectin-4 targeted ADC designed to deliver a TOPO1i payload, inducing tumor cell apoptosis.
  • Nectin-4 is highly expressed in cervical cancer, making it an optimal target for this treatment.
• Regulatory Recognitions:
  • Previously granted Breakthrough Therapy Designation by China’s CDE in December 2024 for advanced urothelial carcinoma.
  • Received Fast Track Designation from the U.S. FDA in April 2024.

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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