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CIM’s Cancer Vaccine CIMAvax Confirmed Immunogenic in US Study, Cuba Announces
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The Cuba-based Molecular Immunology Center (CIM), part of the state-run conglomerate BioCubaFarma, has shared updates on the status of clinical trials (CTs) for two of its drug candidates being conducted abroad. CIM Director Tania Crombet revealed that a US study, in collaboration with the Roswell Park Cancer Institute, has confirmed…
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Huadong Medicine’s HDM1002 Receives FDA Approval for Clinical Trials
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Huadong Medicine Co., Ltd (SHE: 000963), a leading China-based pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug HDM1002. This small molecule is a complete agonist of the GLP-1 receptor with oral activity, known for its…
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Betta Pharmaceuticals and EyePoint Pharmaceuticals Submit EYP-1901 for NMPA Review
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that the clinical trial filing for its EYP-1901 intravitreal implant, co-filed with EyePoint Pharmaceuticals, Inc (NASDAQ: EYPT), has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended to be assessed as a potential treatment for pathological myopia…
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Wuhan Institute’s Hexavalent Rotavirus Vaccine on Track for Priority Review by CDE
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The Center for Drug Evaluation (CDE) website has indicated that Wuhan Institute of Biological Products Co., Ltd’s oral hexavalent reconstituted rotavirus live vaccine (Vero cells) is on course for priority review. This priority status is granted for the vaccine’s use in preventing acute gastroenteritis caused by rotavirus in infants and…
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Kintor Pharmaceutical’s KX-826 Shows Promise in Phase II Study for Male Androgenetic Alopecia
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced the conclusion of a randomized, double-blind, placebo-controlled Phase II clinical study for its drug candidate KX-826 (pyrilutamide) in the US for the treatment of male patients with androgenetic alopecia (AGA). The study demonstrated that KX-826 can promote hair growth, with statistically and…
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CNIPA Releases Patent Linkage Decisions, Paving Way for Generic Drugs in China
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The China National Intellectual Property Administration (CNIPA) has released the latest batch of completed patent linkage cases, following the new legal framework introduced with China’s amended Patent Law, which came into effect from July 2021. Decisions on Generic and Originator PatentsThe decisions covered 9 molecules and 19 patent challenge verdicts,…
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Guangdong Taienkang’s CKBA Ointment for Vitiligo Accepted for Review by China’s NMPA
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Guangdong Taienkang Pharmaceutical Co., Ltd, (SHE: 301263), a China-based pharmaceutical company, has announced that the National Medical Products Administration (NMPA) has accepted a Phase II clinical trial filing for its CKBA ointment in the treatment of vitiligo. The Category 1 chemical drug is also currently undergoing a Phase IIa clinical…
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Mabwell’s B7-H3 Targeting ADC 7MW3711 Accepted for Review by China’s NMPA
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a China-based biopharmaceutical company, has announced that its clinical trial application for 7MW3711, an antibody drug conjugate (ADC) targeting B7-H3, has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of advanced solid tumors.…
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CStone Pharmaceuticals’ Partner Servier Secures EU Approvals for IDH1 Inhibitor Tibsovo
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CStone Pharmaceuticals’ (HKG: 2616) French partner, Servier, has announced receiving two new indication approvals for Tibsovo (ivosidenib), a first-in-class IDH1 inhibitor, from the European Committee. This marks a significant expansion in the drug’s approved uses for treating specific types of leukemia and cholangiocarcinoma. New Indications for Tibsovo in EuropeTibsovo is…
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Innovent Biologics’ Mazdutide Showcases Weight Loss Efficacy in Phase II Study for Chinese Adults
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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…
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Joincare Pharmaceutical Receives NMPA Approval for Triptorelin Microspheres for Prostate Cancer
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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…
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Zai Lab’s Repotrectinib on Track for Priority Review by China’s CDE for ROS1+ NSCLC
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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…
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Sichuan Kelun Pharmaceutical’s A166 Anti-HER2 ADC NDA Accepted for Review by NMPA
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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…
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Mabwell Bioscience’s 9MW3911 Receives NMPA Approval for Clinical Trial in Advanced Tumors
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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…
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Akeso Biopharma Initiates Phase III Study for Ivonescimab in Non-Small Cell Lung Cancer
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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,…
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Zai Lab Limited Reports Q1 2023 Financial Results and Product Highlights
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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…
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Yifan Pharmaceutical’s F-627 Receives NMPA Approval for Neutropenia Treatment in Cancer Patients
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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…
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Jiangsu Nhwa Pharmaceutical Receives NMPA Approval for Olinvyk (Oliceridine) Injection
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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…
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Innovent Biologics’ Tyvyt Secures NMPA Approval for EGFR-Mutated NSCLC Treatment
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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)…
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Grand Pharmaceutical Group Files NDA for Ophthalmic Analgesic APP13007 with US FDA
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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…
