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BeiGene (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in Macau for 9 indications. This marks the first time tislelizumab has received approvals outside of the China mainland market, with the Macau drug regulator’s decisions based on those issued by…
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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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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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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 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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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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US-based Eyenovia, Inc. (NASDAQ: EYEN) has announced obtaining market approval from the US Food and Drug Administration (FDA) for its Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%. This product is indicated for inducing mydriasis during diagnostic procedures and in conditions requiring short-term pupil dilation. A Milestone in Ophthalmic Drug…
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UK major AstraZeneca (AZ, NASDAQ: AZN) has announced that its mitogen-activated protein kinase (MEK) inhibitor, Koselugo (selumetinib), has been approved in China for the treatment of symptomatic, inoperable plexiform neurofibromatosis (PN) in pediatric patients with neurofibromatosis type 1 (NF1) aged three years and above. This marks a significant advancement in…
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that it has received approval from China’s National Medical Products Administration (NMPA) for four applications related to Brukinsa (zanubrutinib), the company’s Bruton’s tyrosine kinase inhibitor (BTKi). The approvals include two supplemental New Drug Applications (sNDAs) for the treatment of treatment-naïve…
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US-based medical technology firm Omega Medical Imaging has received marketing approval from the US Food and Drug Administration (FDA) for its Soteria.AI, an image-guided X-ray system specifically designed for interventional cardiology labs. This marks a significant milestone as Soteria.AI is hailed as the first artificial intelligence (AI)-enabled X-ray system approved…
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Gan & Lee Pharmaceuticals (SHA: 603087), a China-based pharmaceutical company, has announced that it has received marketing approval from Bolivia’s State Agency of Drugs and Health Technologies (AGEMED) for its insulin glargine product, which comes in a pre-filled format. Insulin Glargine: A Long-Acting Insulin AnalogueInsulin glargine is a long-acting insulin…
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China-based Rainmed Medical Limited has announced that it has received market approval from the National Medical Products Administration (NMPA) for its innovative coronary artery function measurement system, the caIMR system. Microcirculatory Resistance Index (IMR) and Its Clinical SignificanceThe microcirculatory resistance index (IMR) is a quantitative method used to evaluate the…
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ChengDu ShengNuo Biotech Co., Ltd (SHA: 688117), a China-based polypeptide specialist, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Shire’s Firazyr (icatibant). This marks a significant milestone as the company becomes the first manufacturer to file for Drug…
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U.S.-based pharmaceutical giant Pfizer (NYSE: PFE) has reported receiving an additional indication approval from the National Medical Products Administration (NMPA) for its globally successful vaccine, Prevenar 13. The approval extends the vaccine’s use to infants and children aged between 6 weeks to 5 years (before the 6th birthday), expanding the…
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Hunan Warrant Pharmaceutical Co., Ltd (SHA: 688799), a China-based pharmaceutical company, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its generic version of Menarini’s brivudine. This approval signifies that Warrant Pharma’s version of the drug has successfully passed the generic quality consistency evaluation (GQCE) and…
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Vericor-14 microcatheter. The product is now approved for use in percutaneous intervention surgery of coronary arteries and peripheral blood vessels, providing targeted access to the lesion site of narrow…
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Janssen’s Spravato (esketamine) has been granted approval by the National Medical Products Administration (NMPA) in China for the alleviation of depressive symptoms in adult patients with acute suicidal ideation or behavior when used in combination with an oral antidepressant. Spravato: A Novel Antidepressant with Rapid-Onset ActionSpravato marks a significant advancement…
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its paclitaxel-coated arteriovenous fistula high-pressure balloon dilation catheter, ACOART AVENS. The product is intended for use in percutaneous transluminal angioplasty (PTA) for autologous arteriovenous fistula stenosis in hemodialysis patients. Product…
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, orelabrutinib. The drug can now be used to treat recurrent/refractory marginal zone lymphoma (MZL), marking it as the first BTK inhibitor for that…
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The National Medical Products Administration (NMPA) has granted import approval to US firm Alcon Laboratories, Inc. for its innovative intraocular lens, marking it as the 197th innovative medical device to be approved by the bureau. Product Features and BenefitsThe product in question is a one-piece posterior chamber intraocular lens that…