Chinese pharmaceutical company manufacturing antineoplastics, cardiovascular medication, painkillers, antibiotics, and related products; the largest listed pharmaceutical company in China.
Clinical Trials
425
45 active
Approvals
362
Total approvals
Agencies
3
Regulatory bodies
Founded
1997
Active, not recruiting
25
5.9%
Completed
24
5.7%
Not yet recruiting
20
4.7%
Recruiting
31
7.3%
Terminated
2
0.5%
Unknown
323
76.0%
- China's NMPA has accepted a marketing authorization application from Hengrui Pharma subsidiary Fujian Shengdi Pharmaceutical for rupobartide injection in adults with type 2 diabetes. - The filing rests on two pivotal Phase III trials, PRIME-1 and PRIME-2, which tested rupobartide against placebo and against 1 mg semaglutide injection. - In PRIME-2, rupobartide 4 mg and 2 mg cut HbA1c by 2.78% and 2.34% at week 36, both non-inferior to semaglutide's 2.29%, with 4 mg superior on key secondary endpoints.
- Hengrui Pharma and Novaliq announced NMPA approval of Heng Yi (0.1% cyclosporine ophthalmic solution) on June 23, 2026, for the treatment of dry eye disease. - Heng Yi is the first and only water-free cyclosporine ophthalmic solution in China, based on Novaliq's EyeSol platform, and the second EyeSol-based product approved in the country. - The Phase III SHR8028-301 bridging trial met its primary endpoint, demonstrating a statistically significant reduction in total corneal fluorescein staining score at Day 29 (treatment: −4.8 vs control: −3.0; P<0.0001). - The approval positions Hengrui to address both aqueous-deficient and evaporative dry eye subtypes through a combined portfolio with previously approved Heng Qin.
- Hengrui's Phase 2 trial of oral ribupatide showed participants achieved mean weight loss up to 12.1% with no plateau at Week 26, with 38.6% achieving at least 15% weight loss. - Kailera presented Phase 1 bridging study data for ribupatide injection at ADA 2026, supporting their ongoing global Phase 3 KaiNETIC clinical program. - The companies are advancing multiple formulations of ribupatide, a GLP-1/GIP receptor dual agonist, including oral and injectable versions for obesity treatment. - Kailera initiated a U.S. Phase 2b high-dose obesity trial evaluating up to 20 mg ribupatide injection doses in 250 participants over 48 weeks.
- Hengrui Pharma and its subsidiaries received NMPA clinical trial approvals for five oncology drugs, including HRS-6093, a novel oral KRAS G12D inhibitor with no similar approved products globally. - The approved pipeline includes SHR-9839, a dual-pathway blocking humanized antibody, and SHR-1826, a c-Met targeting antibody-drug conjugate with cumulative R&D investments totaling over RMB 400 million. - The company's adalimumab injection, already approved for small cell lung cancer treatment in 2023, received additional clinical trial approval alongside SHR-8068, an anti-CTLA-4 monoclonal antibody. - Total cumulative R&D investment across all five programs amounts to approximately RMB 789.27 million, reflecting significant commitment to oncology drug development.
- HRS-1893, a next-generation cardiac myosin inhibitor, demonstrated rapid and substantial reductions in left ventricular outflow tract gradient with up to 86% complete response rates in a 42-patient Phase 2 study. - The investigational therapy showed minimal impact on left ventricular ejection fraction (1.8-2.7% decrease) while achieving target gradient reduction below 30 mmHg as early as day 5. - Results suggest potential for simplified dosing with minimal titration requirements, addressing key limitations of current therapies for obstructive hypertrophic cardiomyopathy. - The positive data support initiation of a global pivotal clinical study planned for 2026, marking a significant advancement in treatment options for this cardiac condition.
- GSK5764227 (HS-20093) is an investigational HER2-directed antibody-drug conjugate being developed through collaboration between GSK and Hansoh Pharma for patients with HER2-expressing solid tumors. - The ARTEMIS-001 first-in-human Phase I trial is evaluating safety, tolerability, and preliminary antitumor activity in heavily pretreated patients with advanced or metastatic HER2-positive cancers. - Early clinical data indicate manageable safety profile with predominantly low-grade adverse events and biological activity across multiple HER2-expressing tumor types, including patients previously treated with other HER2-targeted therapies. - The next-generation ADC is engineered to address limitations of first-generation HER2 conjugates through optimized drug-to-antibody ratio, linker stability, and tumor-selective payload release.
- QureBio's Q-1802, a CLDN18.2/PD-L1 bispecific antibody, demonstrated a 70% overall response rate and 11.3-month median progression-free survival in 60 patients with advanced gastric/gastroesophageal junction cancer. - The Phase Ib/II trial showed manageable safety profile with no dose-limiting toxicities observed and only 6.5% permanent discontinuation rate due to adverse events. - Response rates improved to 81.8% in patients with high CLDN18.2 expression and PD-L1 CPS≥5, supporting advancement to Phase III trials. - Chinese regulatory authorities have approved the Phase III trial for Q-1802 at the recommended 10 mg/kg dose in combination with XELOX chemotherapy.
- Kailera Therapeutics has begun randomizing participants in its KaiNETIC global Phase 3 program for ribupatide, a dual GLP-1/GIP receptor agonist targeting obesity treatment. - Previous Chinese trials demonstrated impressive weight loss results, with ribupatide achieving 23.6% weight reduction after 36 weeks compared to 1.8% with placebo. - The comprehensive Phase 3 program includes three trials enrolling over 4,700 participants across multiple regions, with doses up to 10 mg evaluated over 76 weeks. - The program specifically targets patients with severe obesity (BMI ≥35 kg/m²), addressing a critical unmet need as this population is projected to represent half of U.S. adults with obesity by 2030.
- AbbVie has signed a $1.1 billion licensing deal with China's Zelgen Biopharmaceuticals for global rights to alveltamig (ZG-006), a trispecific T-cell engager targeting DLL3-expressing tumors. - The agreement includes a $100 million upfront payment and up to $1.075 billion in potential milestone payments, with Zelgen retaining commercialization rights in Greater China. - Alveltamig is currently in Phase I/II trials for small cell lung cancer and neuroendocrine carcinoma, targeting DLL3 which is expressed in over 70% of small cell lung cancers. - This deal represents the latest in a series of major DLL3-focused partnerships, following similar billion-dollar agreements by Hengrui Pharma and Innovent Bio in recent years.
- China's 2025 National Reimbursement Drug List successfully added 114 drugs with an 88% success rate, including 50 Class I innovative drugs, marking significant support for genuine pharmaceutical innovation. - All five CAR-T cell therapies achieved breakthrough inclusion in the inaugural commercial insurance innovative drug directory, alongside 19 total innovative drugs, creating new payment pathways for high-value treatments. - The dual-track "basic medical insurance + commercial health insurance" model addresses previous cost-effectiveness barriers for expensive therapies while maintaining focus on clinical value and unmet medical needs. - Major pharmaceutical companies including Hengrui Pharma, Innovent Bio, Pfizer, and Johnson & Johnson secured multiple product inclusions, with Alzheimer's treatments and rare disease therapies gaining commercial insurance coverage.
