Zhangjiang Pharma Valley Enterprises Showcase Innovation Momentum: From Clinical Breakthroughs to NDA Submissions

Oct 27, 2025 15:49 CST Updated 15:49

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

Akeso

Innovative Antibody Drug Developer

Recently, there has been a series of positive developments in Zhangjiang Pharmaland: marketing authorization acceptance, completion of the first patient dosing, and potential inclusion in breakthrough therapy. Progress from Zhangjiang pharmaceutical companies continues to accelerate.

Hansoh Pharma's HS-10365 Capsule Marketing Authorization Application Accepted by NMPA

October 23,Zhangjiang Pharma Valley Enterprise Hansoh PharmaHansoh Pharma announced that the New Drug Application (NDA) for HS-10365 capsules, a highly selective Rearranged during Transfection (RET) inhibitor independently developed by the company, has been accepted by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for RET gene fusion.

HS-10365 is a Class 1 innovative drug independently developed by Hansoh Pharma. As a small-molecule, highly selective RET receptor tyrosine kinase inhibitor, it directly targets intracellular protein tyrosine kinases, competitively binding with ATP to inhibit tyrosine kinase phosphorylation, thereby effectively controlling tumor growth.

At the 114th American Association for Cancer Research (AACR) Annual Meeting in 2023, the Phase I dose-escalation trial data of HS-10365 was presented for the first time. The results showed that HS-10365 achieved an ORR of 83.3% in treatment-naïve patients with advanced RET fusion-positive NSCLC and an ORR of 66.7% in previously treated NSCLC patients. HS-10365 demonstrated superior antitumor activity in patients with RET fusion-positive advanced NSCLC, along with a favorable safety and tolerability profile. Further registrational clinical study results will be released at other international conferences subsequently.

3D Medicines' First RDC Drug 3D1015 IIT Study Completes First Patient Dosing

October 23,Zhangjiang Pharma Valley Company 3D Medicines3D Medicines(Shanghai) Co., Limited announced that the investigator-initiated trial (IIT) titled "Safety and Radiation Dosimetry Assessment of 3D1015 Injection" for its core RDC candidate drug 3D1015, which was independently developed by the company with exclusive global rights, has successfully completed the first patient dosing on August 27, 2025, in patients with metastatic castration-resistant prostate cancer (mCRPC). The patient has now completed follow-up, and the trial will continue to progress as planned.

Preliminary results showed that the drug had a significant enrichment effect on target lesions. No drug-related adverse reactions of grade 3 or higher were observed after a single dose. Moreover, at a dose only 1/20 of the approved similar products, a downward trend in patients' prostate-specific antigen (PSA) was observed, laying a solid foundation for subsequent clinical studies.

As a domestically developed RDC candidate drug in China, if 3D1015 can continue to demonstrate its advantages in subsequent clinical studies, it is expected to become the next-generation RDC treatment option following Pluvicto. It may bring more benefits to mCRPC patients worldwide in terms of dose optimization, toxicity control, and treatment costs.

Akeso's PD-1/VEGF Bispecific Antibody New Indication Proposed for Breakthrough Therapy Designation

October 24,Zhangjiang Medipost Valley Enterprise AkesoAkeso's Novel Drug Class 1 PD-1/VEGF Bispecific Antibody Ivonescimab (AK112) Injection is Proposed for Inclusion in the Breakthrough Therapy Designation, with the Indication: Ivonescimab Combined with Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.

Triple-negative breast cancer is characterized by strong heterogeneity, poor differentiation, high invasiveness, and a higher likelihood of earlier recurrence and metastasis. More than one-third of patients with triple-negative breast cancer will experience recurrence or distant metastasis. Recurrent or metastatic triple-negative breast cancer typically has a poor prognosis, with a 5-year survival rate of less than 15%, representing a significant unmet clinical need.

Ivonesc is a novel bispecific antibody with a synergistic anti-tumor mechanism of "tumor immunity + anti-angiogenesis." This drug can simultaneously target two key targets, PD-1 and VEGF, and synergistically exert dual mechanisms of tumor immunity and tumor anti-angiogenesis, which is expected to bring more efficient treatment options for such patients.

Comprehensive Editor: Hansoh Pharma, Akeso, Medicinal Observer