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Beijing Tiantan Biological Completes Phase I Study for Recombinant Coagulation Factor VIIa
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China-based Beijing Tiantan Biological Products Co., Ltd (SHA: 600161) has announced the conclusion of a Phase I clinical study for its recombinant human coagulation factor VIIa for injection. The company is now preparing for a Phase III study, which is expected to commence soon. This advanced treatment is aimed at…
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Shanghai’s SMPA Notification: Non-Winning Bids in VBP Round 8 Can Avoid “Higher Price” Label
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Shanghai’s Sunshine Medical Procurement All-in-One (SMPA) has released a notification concerning the 8th round of the national volume-based procurement (VBP) program. The notification indicates that non-winning bids eligible for the 8th VBP round and successfully put up for online procurement in Shanghai can avoid being labeled as “drugs with higher…
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US FDA Issues Warning Letter to Chengdu KeCheng Fine Chemicals Over Communication Failures
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The US FDA’s Center for Drug Evaluation (CDE) issued a warning letter to China-based Chengdu KeCheng Fine Chemicals Co., Ltd earlier this month, following the company’s repeated failure to respond to the agency’s attempts to establish contact. The warning was prompted by the company’s avoidance of follow-up communications and its…
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Grand Pharmaceutical Initiates Phase I Study for TLX250-CDx in Renal Mass Imaging
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the Phase I clinical study for its TLX250-CDx (89Zr-DFO-girentuximab), an imaging agent licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a deal valued at up to USD 225 million in 2020. Phase I Study Design…
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Teva Pharmaceutical’s Copaxone Approved by NMPA for Multiple Sclerosis Treatment in China
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The National Medical Products Administration (NMPA) website has indicated that Israel-based Teva Pharmaceutical Industries’ (NYSE: TEVA) innovative chemical drug Copaxone (glatiramer acetate) has been approved for use as a treatment for multiple sclerosis (MS) in China. This marks the second MS therapy available in China following Bristol-Myers Squibb (BMS, NYSE:…
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Fosun Pharmaceutical’s Sisram Opens Wellness Center in Chicago for Beauty and Health
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the establishment of the Sisram Wellness Center in Chicago, United States, by its medical aesthetic solutions unit Sisram (HKG: 1696). This new venture marks the company’s expansion into providing comprehensive beauty and health experience services. Services Offered at…
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Sanyou Biopharmaceuticals and Huadong Medicine Expand Partnership on Macromolecule Therapeutics
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China-based Sanyou Biopharmaceuticals Co., Ltd has announced a licensing deal with compatriot firm Huadong Medicine Co., Ltd (SHE: 000963), expanding their strategic partnership initially formed in November 2020. The agreement focuses on the co-development of innovative bispecific antibodies (BsAbs) and antibody drug conjugates (ADCs), marking a significant step forward in…
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Daewoong Pharmaceutical Files NDA in China for Potassium-Competitive Acid Blocker Fexuclu
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South Korea-based Daewoong Pharmaceutical (KRX: 069620) has revealed that a new drug application (NDA) has been filed in China for Fexuclu/Abcito (fexuprazan) in a 40mg dosage form. Fexuclu, an in-house developed potassium-competitive acid blocker (P-CAB), represents a new generation of therapies for gastroesophageal reflux disease (GERD). Advantages of P-CABs Over…
