•
China’s National Medical Products Administration (NMPA) has approved ROBO Medical’s gastrointestinal endoscopic surgical instrument control equipment, an innovative product now eligible for clamping and pulling diseased tissues during submucosal dissection of esophagus and stomach endoscopy. Product InnovationThis product, the first home-grown digestive endoscopic integrated robot in China, features a flexible…
•
US giant Bristol-Myers Squibb (BMS; NYSE: BMY) announced receiving another indication approval from the European Commission (EC) for its Breyanzi (lisocabtagene maraleucel; liso-cel). The approval allows the drug to be used in adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Clinical…
•
US-based Inari Medical, Inc. (NASDAQ: NARI), set to be acquired by Stryker (NYSE: SYK), announced last week that it has obtained marketing approval from China’s National Medical Products Administration (NMPA) for its peripheral vein thrombectomy stent system. This marks a significant milestone in the company’s global expansion strategy. Product DetailsThe…
•
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its tegileridine. The Category 1 drug is now approved to treat postoperative moderate to severe pain. Drug Profile and MechanismTegileridine is a μ opioid receptor (MOR)-biased small-molecule agonist. It…
•
Shanghai MicroPort Endovascular MedTech Co., Ltd’s (SHA: 688016) Cratos branched aortic stent graft system has received marketing approval from China’s National Medical Products Administration (NMPA). The approval is for the minimally invasive interventional treatment of thoracic aortic dissection involving branches of the aortic arch. Product InnovationThe Cratos system represents an…
•
China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for use in combination with chemotherapy for first-line recurrent or metastatic nasopharyngeal carcinoma (NPC). Commercialization and Market PresencePenpulimab, a differentiated PD-1 therapy,…
•
China-based Innovent Biologics Inc. (HKG: 1801) announced that its New Drug Application (NDA) for Sycume (teprotumumab), a recombinant anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, has been approved by China’s National Medical Products Administration (NMPA). This approval marks Sycume as China’s first and the world’s second approved IGF-1R antibody drug,…
•
Itovebi (inavolisib), a best-in-class PI3Kα inhibitor from Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY), has received approval from China’s National Medical Products Administration (NMPA). The drug is indicated for use in combination with palbociclib and fulvestrant in adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
•
Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products Administration (NMPA) for the ANTERION ophthalmic detector. This multimodal imaging diagnostic platform, developed by its German partner Heidelberg Instruments, integrates three functions into one device, enhancing precision and efficiency in ophthalmic diagnostics. Technical Specifications and…
•
Japan-based Otsuka Pharmaceutical Co., Ltd and its Danish partner Lundbeck A/S (OTCMKTS: HLUBF) jointly announced receiving marketing approval from the European Commission (EC) for Rxulti (brexpiprazole). The atypical oral antipsychotic can now be used to treat schizophrenia in adolescents aged 13 years and older in the European Union (EU). Background…
•
Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced receiving market approval from the National Medical Products Administration (NMPA) for its femtosecond laser corneal refractive surgery system and accompanying disposable eye fixation patient interface. Developed in collaboration with German partner SCHWIND eye-tech-solutions GmbH, the system is designed for producing corneal flaps in…
•
US major Johnson & Johnson MedTech announced receiving U.S. 510(k) regulatory clearance for its MONARCH QUEST. This latest advancement in MONARCH navigation technology features AI-powered algorithms and a verified OEC Open interface with the GE HealthCare OEC 3D mobile CBCT Imaging System. MONARCH QUEST TechnologyThe MONARCH QUEST platform represents a…
•
Swiss giant Novartis’ (NYSE: NVS) Cosentyx (secukinumab) has secured another indication approval from China’s National Medical Products Administration (NMPA), this time for the treatment of moderate to severe hidradenitis suppurativa (HS). This IL-17A-targeted therapy previously gained approval in China for moderate-to-severe plaque psoriasis, ankylosing spondylitis, and active psoriatic arthritis (PsA).…
•
UK-based giant AstraZeneca (NASDAQ: AZN) received approval from China’s National Medical Products Administration (NMPA) for a new indication for its PD-L1 inhibitor Imfinzi (durvalumab). The approval allows Imfinzi to be used in combination with chemotherapy for adults with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC), specifically for patients without…
•
Shanghai-based Huihe Healthcare, a developer of structural heart disease intervention medical devices, announced receiving marketing approval in China for its K-Clip transcatheter tricuspid valve repair system. This approval marks a significant milestone in the treatment of tricuspid regurgitation. Innovation and Market ImpactK-Clip is the first of its kind in China…
•
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its sacituzumab tirumotecan (SKB264/MK-2870). The approval allows the use of this TROP2-targeted antibody drug conjugate (ADC) in adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell…
•
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Ameile (almonertinib). The epidermal growth factor receptor (EGFR) inhibitor is now approved to treat unresectable locally advanced EGFR exon 19 deletion or exon 21 (L858R) replacement mutation-positive non-small…
•
China-based Jiangsu Cowin Biotech Co., Ltd. (SHA: 688426) announced receiving a Category III medical device license from the National Medical Products Administration (NMPA) for its human Septin9, SDC2, and NDRG4 gene methylation detection kit (fluorescence PCR method). This approval marks a significant step forward in the company’s efforts to provide…
•
US giant Bristol-Myers Squibb (BMS, NYSE: BMY) announced receiving marketing approval from the European Commission (EC) for its Opdivo (nivolumab) combined with Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). This approval marks a significant advancement in treatment options for this aggressive…
•
US giant AbbVie (NYSE: ABBV) announced receiving marketing approval from China’s National Medical Products Administration (NMPA) for its Skyrizi (risankizumab). The drug is approved to treat adult patients with moderate to severe active Crohn’s disease who have insufficient response, loss of response, or intolerance to traditional or biologic treatments. The…