Zhangjiang Pharma Valley Innovation Highlights: First Prescriptions, Clinical Approvals, and New Indications

Recently,Zhangjiang Medipost and Yingshuo PharmaceuticalsHansoh Pharma's self-developed Class I innovative drug, Pimitinib Hydrochloride Capsules (Beijiemai®), has been prescribed for the first time globally, accelerating benefits for TGCT patients in China.

As the first and currently only Class I innovative drug approved in China for the treatment of TGCT, Beijiema® was approved by the NMPA for marketing in December 2025. It is indicated for adult patients with symptomatic TGCT for whom surgical resection may lead to functional limitations or severe complications. Previously,Beijiemai®Granted Breakthrough Therapy Designation by NMPA and FDA.

Professor Niu Xiaohui from Beijing Jishuitan Hospital, the principal investigator of the MANEUVER study, stated: “In the past, there were limited clinical treatment options for TGCT, especially for patients with recurrent tumors or those who could not undergo surgical resection, leaving them in long-term therapeutic dilemmas. The clinical application of Beijiemai® has filled this gap, offering the potential to transform TGCT from a difficult-to-treat disease heavily reliant on repeated surgeries into a chronic condition that can be managed in a standardized and comprehensive manner through oral targeted therapy, bringing hope for patients to return to a normal life.”

Recently,Zhangjiang Pharma Valley Enterprise CytoskeletonThe CG105 CAR-T cell injection developed by Hansoh Pharma has received clinical trial approval from the CDE for the treatment of relapsed/refractory multiple myeloma (RRMM).

CG105 CAR-T Cell Injection is developed based on the company's self-developed non-viral DNA technology platform, with its core adopting electroporation-mediated DNA delivery. This is a typical non-viral physical delivery method that forms transient nanopores in the cell membrane through short high-voltage electric pulses, allowing exogenous DNA to directly enter the cytoplasm, thereby achieving efficient, rapid, and virus-free gene delivery.

As an autologous CAR-T product, CG105 can complete the extraction and customization of patient antibody cells within an average of 8 days. The company plans to rely on this non-viral DNA platform to quickly validate efficacy in the field of hematological tumors, and subsequently advance the development of solid tumor and universal pipelines.

On March 27, the NMPA official website showed,Zhangjiang Pharm Valley Multinational AstraZenecaSelumetinib has been approved for a new indication. Based on clinical research progress, it is speculated to be for adult patients with symptomatic, inoperable neurofibromatosis type I (NF1) associated plexiform neurofibromas (PN).

(Image Source: NMPA Official Website)

Selumetinib, developed by Array BioPharma (a Pfizer subsidiary), is a mitogen-activated protein kinase kinase 1 and 2 (MEK1/2) inhibitor. It was first approved for marketing in April 2020 under the brand name Koselugo. In December 2003, AstraZeneca entered into an agreement with Array BioPharma to acquire global rights to selumetinib. In July 2017, AstraZeneca collaborated with Merck to jointly oversee the global development and commercialization of selumetinib.

In May 2023, selumetinib was approved in China for the treatment of patients aged 3 years and older with symptomatic and/or progressive, inoperable neurofibromatosis type I (NF1) associated plexiform neurofibromas (PN).

On March 27, the NMPA official website showed,Zhangjiang Pharma Valley Multinational Enterprise Daiichi SankyoAndAstraZenecaTrastuzumab Deruxtecan Approved for New Indication, Used for Neoadjuvant Treatment of HER2-Positive Breast Cancer Patients.

(Image source: NMPA official website)

The PharmaCube database shows that previously, trastuzumab deruxtecan has been approved for six indications in China, three of which are breast cancer-related. These include: the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2 therapy regimens; the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one systemic therapy during the metastatic disease stage, or who have relapsed within six months after adjuvant chemotherapy or during adjuvant chemotherapy; and adult patients with unresectable or metastatic HR-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultra-low (IHC 0, with membrane staining present) breast cancer who have progressed after one or more lines of endocrine therapy in the metastatic disease stage.