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Fosun Pharmaceutical’s HanDaYuan Seeks NMPA Approval for Expanded Indications in Autoimmune Treatments
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has accepted additional indication approval filings for its biosimilar HanDaYuan, which is modeled after AbbVie’s autoimmune therapy Humira (adalimumab). The company is seeking approval for HanDaYuan to treat polyarthritic juvenile idiopathic…
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CDE Streamlines Patent Dispute Resolution for Generic Drug Filings with New Online Submission Process
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The Center for Drug Evaluation (CDE) has announced a new initiative aimed at enhancing the efficiency of resolving patent disputes during the review process for generic drug market filings. Patent holders, stakeholders, and generic drug applicants can now directly submit applications for setting a waiting period, as well as acceptance…
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Jiangsu Hengrui Receives NMPA Approval for HRS-1167 Clinical Trials in Advanced Solid Tumors
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Jiangsu Hengrui Pharmaceutical Co., Ltd (SHA: 600276) has secured clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy HRS-1167, which will be evaluated in combination with SHR-A1921, bevacizumab, or abiraterone plus prednisone/prednisolone for the treatment of advanced solid tumors. HRS-1167 is a second-generation PARP inhibitor…
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Innovent Biologics Launches Phase I Study for IBI3002, a Bispecific Antibody Targeting Asthma
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Innovent Biologics, Inc. (HKG: 1801), based in China, has announced the initiation of its Phase I clinical study for IBI3002, a pioneering bispecific antibody designed to target Interleukin 4 receptor α (IL-4Rα) and thymic stromal lymphopoietin (TSLP). This innovative therapy aims to address asthma and other type 2 inflammatory diseases…
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CDE Grants Priority Review to Jiu An’s Adrenaline and AnHeart’s Taletrectinib; Two Others Earn Breakthrough Therapy Designation
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The Center for Drug Evaluation (CDE) has announced that Jiu An Pharmaceutical’s adrenaline and AnHeart Therapeutics’ taletrectinib are set for priority review, while Biotheus Inc.’s PM8002 and Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422)’s SKB264 have been designated as breakthrough therapies (BTDs). Adrenaline is gaining priority status due to new…
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Sandoz Agrees to $265 Million Settlement in U.S. Generic Drug Antitrust Case
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Sandoz (SIX: SDZ), the Swiss-based pharmaceutical company, announced this week that its U.S. subsidiaries have reached a settlement in a generic drug antitrust class action, agreeing to pay $265 million to the plaintiffs. The settlement is subject to court approval and includes a provision allowing Sandoz to withdraw if a…
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Huadong Medicine’s MaiLi Extreme Achieves Clinical Study Milestone for Chin Retraction Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that a Chinese clinical study for MaiLi Extreme, an injectable lidocaine-containing sodium hyaluronate by its UK subsidiary Sinclair, has successfully met its primary endpoint, demonstrating good safety data. The study aimed to evaluate the efficacy and safety of MaiLi Extreme injections…
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ARSMO Plastic Aesthetic Hospital Introduces Liquid PCL Implant GOURI in Hainan
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ARSMO Plastic Aesthetic Hospital Holding Co., Ltd. has announced the inaugural application of GOURI, a fully liquid polycaprolactone (PCL) based dermal filler, in its Hainan-based unit. GOURI is a renewable material that utilizes CESABP technology, allowing it to be fully liquid and to decompose gradually, thereby promoting the natural regeneration…
