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BioCity Biopharma Receives FDA IND Approval for CD3-EGFR BsAb BC3448
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China-based biotechnology company BioCity Biopharma has announced that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its cluster of differentiation-3 (CD3) epidermal growth factor receptor (EGFR)-targeted bispecific antibody (BsAb), BC3448. With this approval, the company will now initiate a Phase I…
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Ascentage Pharma’s Lisaftoclax (APG-2575) Gets FDA Green Light for Phase III Study
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China-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a regulatory Phase III clinical study for its novel Bcl-2 inhibitor, lisaftoclax (APG-2575). The study will evaluate the efficacy of lisaftoclax in combination with a Bruton’s tyrosine kinase…
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Hansoh Pharmaceutical Regains Rights to Ameile After EQRx Partnership Cancellation
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Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced the cancellation of its partnership and licensing agreement with US-based EQRx Inc. (NASDAQ: EQRX) concerning the epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib). As a result, the Chinese company will regain research and development (R&D), manufacturing, and commercialization rights to…
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Chia Tai Tianqing Secures Exclusive Rights to InventisBio’s D-1553 in China Licensing Deal
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China-based Chia Tai Tianqing has signed a licensing agreement with compatriot firm InventisBio, securing exclusive rights to develop, regulate, manufacture, and commercialize InventisBio’s D-1553 in mainland China. The agreement also provides Chia Tai Tianqing with potential ex-China territorial rights based on future data-sharing, although no financial details have been disclosed.…
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Our United Corporation’s Linear Accelerator Approved as Innovative Medical Device by NMPA
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Xi’an-based Our United Corporation has announced that its medical electronic linear accelerator has been approved by the National Medical Products Administration (NMPA) as an innovative medical device. This marks a significant milestone for the company and the field of radiation therapy in China. Comprehensive Features of the Linear AcceleratorThe product,…
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BeiGene and Bristol-Myers Squibb/Celgene Settle Partnership, Termination Set for 2023
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BeiGene (NASDAQ: BGNE) has announced a settlement and termination agreement with US firm Bristol-Myers Squibb/Celgene (BMS, NYSE: BMY), formally ending their previous partnership on December 31, 2023. As part of the agreement, both parties have agreed to withdraw arbitral proceedings. Bristol-Myers Squibb/Celgene will transfer 23,273,108 ordinary shares of BeiGene back…
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ABM Therapeutics’ ABM-1310 Earns Orphan Drug Designation for BRAF V600 Mutant Glioblastoma
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Shanghai-based ABM Therapeutics Inc. has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its small molecule BRAF inhibitor, ABM-1310. This designation is in relation to the molecule’s potential use in treating BRAF V600 mutant glioblastoma (GBM), a rare and aggressive…
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CASI Pharmaceuticals Enters Assignment Agreement with Mundipharma for Folotyn Commercialization in China
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US-based CASI Pharmaceuticals Inc., (NASDAQ: CASI) has announced the execution of an assignment agreement with Mundipharma International Corporation Limited (MICL), Mundipharma Medical Company (MMCo), and Acrotech Biopharma Inc. (Acrotech) for the commercialization of Folotyn (pralatrexate) in China. The financial details of the agreement have not been disclosed. Folotyn (Pralatrexate) for…
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Astellas Pharma’s Zolbetuximab BLA Accepted by China’s CDE for Gastric Cancer Treatment
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE) in China has accepted the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody (mAb), for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or…
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GSK’s Jemperli Receives FDA Approval for First-Line Treatment of Advanced Endometrial Cancer
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GSK plc (NYSE: GSK), a major UK pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has granted market approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab), as a first-line treatment for advanced or recurrent endometrial cancer. This indication is for patients who are to first…
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RemeGen’s Novel Bispecific Antibody RC148 Receives Clinical Trial Approval
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China-based RemeGen Ltd (SHA: 688331, HKG: 9995) has announced that it has received clinical trial approval for its novel bispecific antibody (BsAb), RC148. This development marks a significant step forward in the company’s efforts to address the complex challenges of treating multiple solid tumors. RC148 Development and Phase I Study…
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Jiangsu Hengrui’s Camrelizumab and Apatinib Combo Accepted for FDA Review for HCC Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that the US Food and Drug Administration (FDA) has accepted for review the Biologic License Application (BLA) for its programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab, combined with the small-molecule targeted cancer therapy apatinib, as a first-line treatment for unresectable or…
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Jacobio Pharma’s Glecirasib Enters Breakthrough Therapy Review for Pancreatic Cancer Treatment
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China-based Jacobio Pharma (HKG: 1167) has announced that its novel KRAS G12C inhibitor, glecirasib, has entered into the breakthrough therapy review process for the treatment of locally advanced or metastatic pancreatic cancer with the KRAS G12C mutation. The drug is being developed as a second-line treatment in combination with gemcitabine…
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Lucence and Innovent Biologics Partner to Enhance Access to Cholangiocarcinoma Treatment in Hong Kong
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Singapore-based precision medicine specialist Lucence, with a presence in Suzhou, Hong Kong, and Palo Alto (California, US), has entered into a partnership with China-based Innovent Biologics Inc., (HKG: 1801). This collaboration aims to enhance patient access to Innovent’s Pemazyre (pemigatinib), the world’s first targeted therapy for cholangiocarcinoma (bile duct cancer),…
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Mirxes Holding Company Secures USD 50 Million in Series D Financing for RNA Technology
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Mirxes Holding Company Ltd, a Singapore-headquartered RNA technology company specializing in blood-based miRNA test kit products, has successfully closed a Series D financing round, raising USD 50 million. The funding round was supported by a consortium of existing and new investors, including Beijing Fupu, in which the Zhejiang Anji Economic…
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HanchorBio’s HCB101 Receives WFDA Approval for Multi-Region Clinical Study
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Taiwan-based HanchorBio has announced that it has received approval from the Taiwan Food and Drug Administration (WFDA) to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101. HCB101: A Promising Fusion Protein for Cancer TreatmentHCB101 is an engineered SIRP linked to IgG4-Fc α fusion proteins that can…
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InnoCare Pharma’s ICP-723 Receives NMPA Approval for Pediatric Clinical Study
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Beijing InnoCare Pharma (HKG: 9969), a China-based biotech company specializing in cancer and autoimmune diseases, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its second-generation pan-TRK inhibitor, ICP-723, in pediatric patients aged 2 to 12 years. This follows…
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FDA Approves Daiichi Sankyo’s Vanflyta for FLT3-ITD Positive AML Maintenance Treatment
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The US Food and Drug Administration (FDA) has granted clearance to Japan-based Daiichi Sankyo (TYO: 4568) for its type II FLT3 inhibitor, Vanflyta (quizartinib), as a maintenance treatment following consolidation chemotherapy for newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive in adult patients. Phase III Study Results and…
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Gilead Sciences Halts Development of Magrolimab for HR-MDS Following Phase III Trial Results
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Gilead Sciences (NASDAQ: GILD) has decided to stop pursuing the potential first-in-class immunotherapy, magrolimab, for higher-risk myelodysplastic syndromes (HR-MDS) after obtaining disappointing efficacy data from a Phase III trial. Although the company has not yet released the results, it has confirmed that the study’s primary endpoints included complete response (CR)…
