-
Gracell Biotechnologies Gains IND Approval for GC012F in China
•
Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for its chimeric antigen receptor (CAR) T cell candidate GC012F. The dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step in the development…
-
RemeGen Gains NMPA Approval for RC48 and Pyrotinib Clinical Study
•
China-based RemeGen Ltd (HKG: 9995) has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to initiate an open, single-center Phase Ib/II clinical study. The study will assess the safety, efficacy, and pharmacokinetics of its antibody-drug conjugate (ADC) candidate RC48 (disitamab vedotin) combined with Hengrui pharmamceuticals’ pyrotinib, a…
-
Hengrui Pharmaceuticals Licenses SHR2554 to Treeline Biosciences
•
China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced a licensing agreement with US-based Treeline Biosciences, Inc. The deal grants Treeline exclusive development, manufacturing, and commercialization rights to the pipeline candidate SHR2554 in markets outside of the Greater China area. This strategic partnership aims to expand the global reach of SHR2554,…
-
CSPC Pharmaceutical Licenses ADC SYS6002 to Corbus Pharmaceuticals
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced a licensing agreement with Massachusetts-based Corbus Pharmaceuticals Inc. The deal pertains to CSPC’s anti-nectin-4 antibody drug conjugate (ADC) SYS6002. Under the terms of the agreement, Corbus obtains development and commercialization rights to SYS6002 in the United States, EU, United Kingdom, Canada,…
-
Luye Pharma Initiates Phase I Study for BA1106, a CD25 Monoclonal Antibody
•
China-based Luye Pharma Group (HKG: 2186) has announced the first subject dosing in a Phase I clinical study for its BA1106, an in-house developed CD25 monoclonal antibody (mAb). The study, filed by subsidiary Shandong BoAn Biotechnology Co., Ltd, is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of…
-
Zelgen’s ZGGS15 Accepted for NMPA Review as First Global BsAb Filing
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that a clinical trial filing for its ZGGS15, a bispecific antibody (BsAb) targeting LAG-3 and TIGIT in advanced solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone as ZGGS15 is touted…
-
Hengrui’s HER2-Targeted ADC SHR-A1811 Aims for Breakthrough Designation
•
China’s Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced that its SHR-A1811, an HER2 targeted antibody-drug conjugate (ADC), is on course to obtain breakthrough therapy designation (BTD) status from the Center for Drug Evaluation (CDE) in China. This designation is for the treatment of unresectable or metastatic breast cancer with low…
-
EOC Pharma’s CDK7 Inhibitor EOC237 Accepted for CDE Review
•
EOC Pharma, a biotech operating out of the US and China, has announced that a clinical trial filing for its CDK7 inhibitor EOC237 has been accepted for review by the Center for Drug Evaluation (CDE) in China. This marks a significant milestone in the development of EOC237, which is expected…
-
Nona Biosciences Partners with Mythic Therapeutics for Next-Gen ADCs
•
Nona Biosciences, a wholly owned subsidiary of Harbour BioMed (HKG: 2142), has struck a partnership with US firm Mythic Therapeutics. The collaboration aims to leverage Nona’s HCAb transgenic mice platform technology and antibody discovery services to develop next-generation antibody-drug conjugates (ADCs) targeting multiple tumors. No financial details were disclosed. Partnership…
-
Hinova’s HP530S Accepted for NMPA Review as FAK Inhibitor for Solid Tumors
•
China-based biopharma Hinova Pharmaceuticals (SHA: 688302) has announced that a clinical trial filing for its HP530S, a highly active and selective focal adhesion kinase (FAK) inhibitor against solid tumors, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development of…
-
Qilu Pharmaceutical’s QLS12004 Gains Tacit Clinical Trial Approval
•
The Center for Drug Evaluation (CDE) website indicates that China-based Qilu Pharmaceutical’s Category 1 chemical drug candidate QLS12004 has obtained tacit clinical trial approval. This marks a significant step forward in the development of new treatments for solid tumors, including advanced breast cancer, which is the leading malignant cancer affecting…
-
ImmVira’s MVR-T3011 IT Shows Efficacy in Melanoma Treatment
•
Shenzhen-based biopharma ImmVira has revealed that its first intra-tumoral injection oncolytic virus (OV) product, MVR-T3011 IT, has produced positive signs of efficacy as a treatment for melanoma in late-stage patients who have failed previous immunotherapy. In a Phase II clinical study conducted in China and the United States, monotherapy treatment…
-
Hemay Pharma Completes Series D Financing for Autoimmune and Oncology Drugs
•
China-based Ganzhou Hemay Pharmaceutical Co., Ltd, an innovative drug developer focused on autoimmune diseases and oncology, has announced the completion of a Series D financing round at close to RMB 300 million (USD 44.18 million). This significant funding round was led by Hongfu Investment, with contributions from Jihan Capital, Hainan…
-
SciClone Pharmaceuticals Files for Hong Kong Market Approval of Danyelza
•
SciClone Pharmaceuticals Inc. (Nasdaq: SCLN), which became a China-based company after going private in 2017, has announced that a market approval filing has been made in Hong Kong for its Danyelza (naxitamab) in recurrent or refractory high-risk neuroblastoma. This marks a significant step in the global expansion of this innovative…
-
Asieris Partners with ReviR Therapeutics for Urogenital Cancer Research
•
China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has struck a partnership with compatriot firm ReviR Therapeutics, an artificial-intelligence (AI) and gene tech-powered start-up. The collaboration aims to utilize ReviR’s in-house developed AI drug research and development (R&D) platform and targeted RNA technology to conduct research…
-
Harbour BioMed’s Anti-CCR8 Monoclonal Antibody HBM1022 Receives FDA IND Approval
•
Harbour BioMed (HBM), which operates out of the Netherlands, the United States, and Suzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its in-house developed HBM1022, a novel anti-C-C chemokine receptor type 8 (CCR8) monoclonal antibody (mAb). This marks a significant milestone in the…
-
Gracell’s CAR-T Therapy GC012F Receives FDA IND Approval
•
Shanghai-based biotech Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the US FDA for its chimeric antigen receptor (CAR) T cell candidate GC012F. This dual BCMA/CD19-targeted therapy is set to be assessed in treating relapsed/refractory multiple myeloma (r/r MM), marking a significant step forward in the development…
-
BeiGene Launches Mental Health Program for Cancer Patients
•
China-based biotech BeiGene (Nasdaq: BGNE; HKG: 6160; SHA: 688235) has announced the launch of a new mental health program focused on cancer patients. The “Talk About It: Cancer and Mental Health” program, which includes the website CancerandMentalHealth.com, is designed to ensure that mental health is considered a vital part of…
-
AnHeart Therapeutics Partners with Guardant Health for Taletrectinib Diagnostics
•
Sino-US biopharma AnHeart Therapeutics and US precision oncology firm Guardant Health Inc. (NASDAQ: GH) have unveiled a partnership under which Guardant will provide companion diagnostics in support of AnHeart’s taletrectinib. This collaboration aims to enhance the development, regulatory approval, and commercialization of Guardant360 CDx and Guardant360 TissueNext assays in the…
-
Grand Pharma’s TLX101 Accepted for NMPA Review for Glioblastoma Treatment
•
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that an Investigational New Drug (IND) filing for its TLX101, a radionuclide drug conjugate (RDC) being developed to treat glioblastoma multiforme, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step in the development…
