-
Innovent Biologics’ Mazdutide Showcases Weight Loss Efficacy in Phase II Study for Chinese Adults
•
China-based Innovent Biologics Inc., (HKG: 1801), has announced that a Phase II clinical study assessing the higher dose (9mg) of mazdutide (IBI362) in Chinese adults with obesity has achieved its 24-week primary endpoint. This milestone marks a significant step forward in the development of this potential treatment for obesity. Study…
-
Beijing Medical Insurance Bureau Announces Key Healthcare Initiatives and BMI Expansion
•
The Beijing Municipal Medical Insurance Bureau has released a notification outlining key tasks for the healthcare sector, with a significant focus on Basic Medical Insurance (BMI). The initiatives aim to enhance the healthcare system and improve access to medical services for residents. 1. Expansion of Long-Term Care Insurance Pilot ProjectsThe…
-
Joincare Pharmaceutical Receives NMPA Approval for Triptorelin Microspheres for Prostate Cancer
•
Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380), a China-based pharmaceutical company, has announced that it has obtained market approval from the National Medical Products Administration (NMPA) for its triptorelin microspheres. This treatment is designed for prostate cancer patients who require androgen castration therapy. Innovative Treatment Option for Prostate Cancer…
-
Zai Lab’s Repotrectinib on Track for Priority Review by China’s CDE for ROS1+ NSCLC
•
The Center for Drug Evaluation (CDE) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB) repotrectinib is on track to receive priority review status in China for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ROS1-positive. This priority review status is a reflection of…
-
Sichuan Kelun Pharmaceutical’s A166 Anti-HER2 ADC NDA Accepted for Review by NMPA
•
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted for review its Category 1 new drug application (NDA) for A166, an anti-HER2 antibody drug conjugate (ADC). The drug is intended for the treatment of HER2 positive locally…
-
Suzhou Porton Biologics and Synbio Technologies Partner to Advance Cell and Gene Therapy in China
•
China-based Contract Development and Manufacturing Organization (CDMO) Suzhou Porton Biologics Ltd has entered into a strategic partnership with US-based DNA solutions provider Synbio Technologies. The collaboration aims to integrate resources across the cell and gene therapy (CGT) industry chain, thereby strengthening the development of the CGT industry in China. Porton…
-
Mabwell Bioscience’s 9MW3911 Receives NMPA Approval for Clinical Trial in Advanced Tumors
•
Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced receiving clinical trial approval in China for its 9MW3911, a non-IL-2 blocking CD25 monoclonal antibody (mAb). The National Medical Products Administration (NMPA) has given the go-ahead for the drug to be assessed as a treatment for advanced…
-
Akeso Biopharma Initiates Phase III Study for Ivonescimab in Non-Small Cell Lung Cancer
•
China-based Akeso Biopharma (HKG: 9926) has announced the initiation of a Phase III clinical study for its bispecific antibody (BsAb) ivonescimab (AK112), which targets both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF) in non-small cell lung cancer (NSCLC). Global Phase III HARMONi Study Design and Patient DosingThe global,…
-
Zai Lab Limited Reports Q1 2023 Financial Results and Product Highlights
•
China-based Zai Lab Limited (NASDAQ: ZLAB; HKG: 9688) has announced its financial results for the first quarter of 2023, along with recent product highlights and corporate updates. The company reported total product revenues of USD 62.8 million for the quarter, marking a 36% year-on-year (YOY) growth. Product Sales and ContributionsThe…
-
Yifan Pharmaceutical’s F-627 Receives NMPA Approval for Neutropenia Treatment in Cancer Patients
•
Yifan Pharmaceutical Co., Ltd (SHE: 002019), a China-based pharmaceutical company, has announced receiving market approval from the National Medical Products Administration (NMPA) for its efbemalenograstim alfa (F-627). This in-house developed long-acting recombinant human granulocyte colony stimulating factor (rhGCSF)-Fc fusion protein is indicated for the prevention and treatment of neutropenia in…
-
Jiangsu Nhwa Pharmaceutical Receives NMPA Approval for Olinvyk (Oliceridine) Injection
•
Jiangsu Nhwa Pharmaceutical Co., Ltd. (SHE: 002262), a China-based pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its Olinvyk (oliceridine; TRV130) injection. The approved indication is for adult patients requiring management of acute pain severe enough to necessitate…
-
Innovent Biologics’ Tyvyt Secures NMPA Approval for EGFR-Mutated NSCLC Treatment
•
China-based Innovent Biologics Inc., (HKG: 1801) has announced that the National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) for patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC)…
-
China’s NHC Releases Draft Guidelines for Somatic Cell Clinical Research, Seeks Public Input
•
The National Health Commission (NHC) has released the “Somatic Cell Clinical Research Guidelines (draft proposal)” and is soliciting public feedback until May 24, 2023. These guidelines are designed to provide direction for companies and institutions engaged in clinical trials that do not seek formal market approval, which would otherwise necessitate…
-
Zion Pharma’s ZN-A-1041 Acquired by Roche for Global Development and Commercialization
•
China-based Zion Pharma Ltd, a biotechnology company specializing in the development of brain-penetrable compounds, has announced that Roche (SWX: ROG) has acquired the global rights to Zion’s lead program, ZN-A-1041. This orally administered selective tyrosine kinase inhibitor (TKI) targets the human epidermal growth factor receptor 2 (HER2) and is designed…
-
Grand Pharmaceutical Group Files NDA for Ophthalmic Analgesic APP13007 with US FDA
•
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the filing of a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for APP13007 (GPN00833), a modified hormone nano suspension eye drop co-developed with Taiwan-based Formosa Pharmaceuticals Inc., (TPE: 6838). The drug is in development as an…
-
Neuro3 Therapeutics Secures Exclusive License Deal with Lundbeck for KCNQ2 Activator Programs
•
Neuro3 Therapeutics (Neuro3), a biotechnology company specializing in central nervous system (CNS) diseases with operations in Suzhou, China, and the US, has announced the signing of an exclusive license and option agreement with Denmark-based Lundbeck (OTCMKTS: HLUBF). This deal grants Neuro3 a global license to the intellectual property encompassing two…
-
Organon Reports Q1 2023 Revenue Growth, Highlights Women’s Health and Biosimilars Progress
•
Organon (NYSE: OGN) has released its financial report for the first quarter of 2023, announcing a 3% year-on-year (YOY) increase in revenues, excluding foreign exchange effects, amounting to USD 1.54 billion. This growth was driven by a 3% increase in Women’s Health revenues, a 20% increase in Biosimilars, and a…
-
US FDA Nears Regulatory Decision on Junshi Biosciences’ PD-1 Inhibitor Tuoyi
•
China-based Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) is approaching a significant regulatory milestone as it awaits a decision from the US Food and Drug Administration (FDA) regarding its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab). The company’s co-development partner for North America, US-based Coherus Biosciences Inc., (NASDAQ: CHRS), has…
-
Acorda Therapeutics Strikes Deal with Hangzhou Chance for Inbrija Distribution in China
•
US-based Acorda Therapeutics Inc., (Nasdaq: ACOR) has announced a distribution and supply agreement with Hangzhou Chance Pharmaceuticals Co., Ltd, a Chinese pharmaceutical company. This deal will facilitate the supply of Inbrija (levodopa inhalation powder) to the mainland China market, where it will be used as an intermittent treatment for episodic…
-
RemeGen Ltd Receives Approval for Phase I Clinical Study of RC198 in Solid Tumors
•
RemeGen Ltd (HKG: 9995) has announced that it has received approval from the Human Research Ethics Committees of Australia to conduct a Phase I clinical study for its investigational drug RC198. The study will focus on patients with locally advanced unresectable or metastatic solid tumors. RC198: An Fc Fusion Protein…
