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GSK’s Cabotegravir Receives NMPA Approval for HIV Treatment in China
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The National Medical Products Administration (NMPA) has granted marketing approval for GlaxoSmithKline’s (GSK, NYSE: GSK) cabotegravir, a significant development in HIV treatment options. Both the injection and tablet dosage forms of the drug have been approved for use in China. Cabotegravir: An Innovative INSTI for HIV TreatmentCabotegravir is an integrase…
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Beijing Tinavi Medical’s Knee Replacement Navigation System Approved by NMPA
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Beijing Tinavi Medical Technologies Co., Ltd (SHA: 688277) has received marketing approval from the National Medical Products Administration (NMPA) for its innovative navigation and positioning system designed for knee joint replacement surgery. This marks the 218th innovative product designation granted by China’s NMPA. Innovative 6-DOF Robotic Arm Technology in Knee…
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GeneQuantum Healthcare and Aimed Bio Expand Partnership to Develop Five Novel ADC Drugs
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China-based GeneQuantum Healthcare has unveiled a new agreement to expand its existing partnership with South Korea-based biotech firm Aimed Bio. The collaboration will see the two companies jointly develop up to five novel antibody drug conjugate (ADC) drugs, with the specific molecular and disease targets undisclosed. This expansion follows last…
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BeiGene’s Brukinsa Receives US FDA Review for Relapsed/Refractory Follicular Lymphoma sNDA
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China-based biotechnology company BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has accepted for review a new supplemental new drug application (sNDA) for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The application seeks to add a new indication for the treatment of adults with…
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AstraZeneca and Daiichi Sankyo’s Enhertu Gains New Indication Approval in China for HER2-Low Breast Cancer
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Partners AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have announced that their co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has been granted a new indication approval in China. This marks the drug’s second approval in the country and is specifically for use as a monotherapy in treating…
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US FDA Approves Additional Shipments of Qilu Pharmaceutical’s Cisplatin to Address Shortage
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The US Food and Drug Administration (FDA) is maintaining its reliance on China-based Qilu Pharmaceutical for supplies of the essential chemotherapy drug, cisplatin. Following the initial import of four lots in May, an additional ten lots have been approved this month. The drugs are distributed by Canada-based Apotex and are…
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Shanghai Fosun Pharmaceutical Submits Tenapanor Approval Application to China’s NMPA
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196), a China-based pharmaceutical company, has announced a market approval filing to the National Medical Products Administration (NMPA) in China for its in-licensed tenapanor. The drug is indicated for the control of hyperphosphatemia in adult patients with chronic kidney disease (CKD) who are…
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DNE Group Launches $485 Million Fund for Life Sciences Park in Shanghai Pudong
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China-based infrastructure investor DNE Group has revealed that it has raised a new fund worth over RMB 3.5 billion (USD 485 million) to establish a life sciences park in Shanghai’s Pudong district. The fund, which was opened in Q1 2023, is reportedly backed primarily by China-based insurance companies. The project,…
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LianBio Secures Clinical Supply Agreement with AstraZeneca for SHP2 Inhibitor Trial
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Sino-US biotech firm LianBio (OTCMKTS: LIANY) has announced the signing of a clinical supply agreement with UK pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN). The agreement facilitates LianBio’s plan to test the combination of its pipeline SHP2 inhibitor, BBP-398, with AstraZeneca’s Tagrisso (osimertinib) in a Phase I clinical trial for patients…
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Medidata Partners with ECCO and GoBroad to Transform Cancer Trials with Digital Tech
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Medidata, a wholly owned subsidiary of France firm Dassault Systèmes (EPA: DSY), has announced a strategic partnership with the East Clinical Center of Oncology (ECCO) and GoBroad Healthcare Group. The collaboration aims to explore the digital transformation of cancer clinical trials and enhance the clinical application of Rave EDC (Electronic…
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Shanghai Circode Bio and Pfizer Collaborate to Explore Circular RNA Therapy Potential
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Shanghai Circode Bio has entered into a partnership with US pharmaceutical giant Pfizer (NYSE: PFE) to explore the therapeutic potential of circular RNA (circRNA). This strategic collaboration aims to fully leverage Circode Bio’s unique circular RNA technology platform and combine it with Pfizer’s extensive expertise and experience in the pharmaceutical…
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Kedrion Biopharma Achieves First Product Approval in China for Human Albumin
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Italy-headquartered blood products specialist Kedrion Biopharma has announced that its subsidiary, Bio Products Laboratory (BPL), has received approval from China’s National Institutes for Food and Drug Control (NIFDC) to release human albumin into the Chinese market for the first time. This milestone follows a 2022 partnership established between Kedrion and…
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GRIT Biotechnology’s GT201 TIL Therapy Approved for Clinical Studies by China’s CDE
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The Center for Drug Evaluation (CDE) website has indicated that GRIT Biotechnology, a China-based cell therapy specialist, has received approval for its in-house developed gene engineered tumor-infiltrating lymphocyte (TIL) therapy, GT201, for clinical studies in patients with recurrent or metastatic solid tumors. Optimal Structural Design and Custom Retroviral System for…
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Novartis Terminates TIGIT-Targeted Antibody Deal with BeiGene, Retains Rights to Ociperlimab
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Swiss pharmaceutical giant Novartis AG (NYSE: NVS) has decided to terminate an option and license deal with China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235), which was focused on the development of BeiGene’s TIGIT-targeted antibody drug, ociperlimab. The initial deal, signed in December 2021, included a USD 300 million upfront…
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Biocytogen Pharmaceuticals Awarded CNIPA Patent for RenMab Human Antibody Mice Platform
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315), a China-based biopharmaceutical company, has announced receiving a patent award from the China National Intellectual Property Administration (CNIPA) for its in-house developed human antibody mice RenMab platform. The patent, titled “Genetically modified non-human animals with humanized immunoglobulin loci”, is valid through February 18,…
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Guangdong’s OptoMedic Secures Over $27.8 Million in Pre-IPO Financing for Endoscopy Innovations
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OptoMedic Technologies, Inc., a leading endoscopy specialist based in Guangdong, has reportedly raised upwards of RMB 200 million (USD 27.8 million) in a pre-IPO financing round. The round was led by CCB Private Equity Investment and Huajin Capital, with participation from Guoxin Capital and Befor Capital. The funds will be…
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Jiangsu Hengrui Pharmaceuticals’ Irinotecan and Bupivacaine Liposome Injections Get Clinical Trial Green Light in China
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark a significant step forward in the development of these targeted therapies. Irinotecan Liposome Injection for Advanced Colorectal Cancer…
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Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This…
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Jiangsu Hengrui Pharmaceuticals Receives Clinical Trial Approvals for Irinotecan and Bupivacaine Liposome Injections
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a China-based pharmaceutical company, has announced receiving separate clinical trial approvals in China for its irinotecan liposome injection and bupivacaine liposome injection. These approvals mark significant steps in advancing the company’s pipeline in oncology and pain management. Irinotecan Liposome Injection for Advanced Colorectal…
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Shanghai Junshi Biosciences’ Tuoyi Files for 9th Indication in China for RCC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the National Medical Products Administration (NMPA) has accepted for review an additional indication approval filing for its Tuoyi (toripalimab), a programmed death-1 (PD-1) inhibitor, in combination with axitinib for first-line unresectable or metastatic renal cell carcinoma (RCC). This…
