-
US FDA Approves HutchMed and Takeda’s Fruzaqla for Metastatic Colorectal Cancer Treatment
•
The US Food and Drug Administration (FDA) has granted approval to HutchMed (NASDAQ: HCM) and its partner Takeda (NYSE: TAK, TYO: 4502) for their oral tyrosine kinase inhibitor Fruzaqla (fruquintinib), marking the second approval this year for a China-developed innovative drug. The drug is indicated for adult patients with previously…
-
Gaush Meditech Ltd Receives NMPA Approval for Rigid Corneal Contact Lens
•
Gaush Meditech Ltd (HKG: 2407), a company based in Suzhou, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its rigid corneal contact lens. This development marks a significant step forward for the company, as it now offers a highly rigid gas permeable…
-
Amoy Diagnostics Receives NMPA Approval for MSI Detection Kit as Companion Diagnostic for Immunotherapy
•
Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685), a prominent player in the Chinese diagnostics industry, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its human microsatellite instability (MSI) detection kit. This kit, which utilizes fluorescent PCR capillary electrophoresis,…
-
Wuhan Hiteck Biological Pharma Receives NMPA Approval for Aponermin in Multiple Myeloma Treatment
•
Wuhan Hiteck Biological Pharma Co., Ltd (SHE: 300683), a Chinese biopharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its drug Aponermin. This approval is for the treatment of adult patients with recurrent or refractory multiple myeloma who have previously undergone…
-
Sino Medical Sciences Technology Secures TFDA Approval for HT Supreme Drug-Eluting Stent System
•
Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for its HT Supreme drug-eluting stent system. This significant milestone marks the company’s expansion into the Taiwan market with a cutting-edge drug-device…
-
Luye Pharma Group’s Rivastigmine Patch LY03013 Approved by China’s NMPA for Alzheimer’s Treatment
•
China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its rivastigmine twice-weekly transdermal patch (LY03013), a treatment for symptoms of mild and moderate Alzheimer’s disease (AD). Product Development and AdvantagesLY03013, a modified version of rivastigmine, was developed…
-
Novartis’ Cosentyx Gains FDA Approval for Hidradenitis Suppurativa Treatment
•
The US Food and Drug Administration (FDA) has issued regulatory approval for Novartis’ (NYSE: NVS) IL-17A-targeting drug Cosentyx (secukinumab) for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa (HS). This approval positions Cosentyx as a new entrant in the HS biologic therapy market, potentially challenging AbbVie’s (NYSE: ABBV) Humira…
-
Siyi Intelligence Secures Approval for Innovative Rehabilitation Robots in China
•
Shanghai-based Siyi Intelligence, a developer of soft rehabilitation robots, has announced that it has received marketing approvals from the National Medical Products Administration (NMPA) for two of its groundbreaking rehabilitation robots: the “Yisheng Upper Limb Intelligent Rehabilitation Training and Evaluation System” and the “Yisheng Brain Computer Interface (BCI) Rehabilitation Training…
-
CStone Pharmaceuticals Receives NMPA Approval for Sugemalimab in R/R ENKTL
•
CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced that it has received a new indication approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor. The drug is now approved for the treatment of recurrent or refractory extranodal NK/T cell lymphoma (R/R…
-
Simcere Pharmaceutical Group Secures Full Approval for Cosela in China
•
Simcere Pharmaceutical Group (HKG: 2096), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has converted the first conditional approval in China for Cosela (trilaciclib) to full approval. Originally discovered by US biotech G1 Therapeutics Inc, trilaciclib was in-licensed by Simcere in August…
-
Roche’s Vabysmo Receives FDA Approval for Macular Edema Treatment Following RVO
•
Swiss pharmaceutical giant Roche (SWX: ROG) announced last week that it has received an indication extension approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Vabysmo (faricimab) to treat macular edema following retinal vein occlusion (RVO). This approval broadens the therapeutic applications of Vabysmo, which…
-
Dr. Reddy’s Laboratories Reports 9% YOY Revenue Growth in Q2 2024 Fiscal Year
•
India-based generics giant Dr. Reddy’s Laboratories Ltd (NYSE: RDY) has released its financial report for the Q2 2024 fiscal year ended September 30, 2023. The company reported consolidated revenues of USD 828 million for the quarter, marking a 9% year-on-year (YOY) increase. This growth was primarily driven by robust generic…
-
Junshi Biosciences’ PD-1 Inhibitor Loqtorzi Approved by FDA for Nasopharyngeal Carcinoma
•
China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that the US FDA has approved its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), for the treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). The approval marks a significant milestone as Loqtorzi becomes the first…
-
Everest Medicines’ Nefecon Receives First Regional NDA Approval in Macau for IgAN Treatment
•
China-based Everest Medicines (HKG: 1952) has announced that its New Drug Application (NDA) for Nefecon, a treatment for primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression, has been approved by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region, China. This marks the first regional…
-
GSK’s ViiV Healthcare Secures NMPA Approval for Vocabria in HIV-1 Treatment
•
UK pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that its HIV joint venture, ViiV Healthcare, has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir injection). The drug is approved for use in combination with Johnson & Johnson/Janssen Pharmaceutical’s (J&J, NYSE: JNJ) Rekambys (rilpivirine long-acting injection)…
-
AbbVie’s Rinvoq Gains Two New Indications in China: AxSpA and Ankylosing Spondylitis
•
US-based pharmaceutical company AbbVie (NYSE: ABBV) has announced the receipt of two additional indication approvals from China’s National Medical Products Administration (NMPA) for its drug Rinvoq (upadacitinib). The selective JAK inhibitor is now approved for treating adult patients with active radiologically negative axial spinal arthritis (axSpA) who show a poor…
-
Eli Lilly’s Omvoh Receives FDA Approval for Ulcerative Colitis Treatment
•
The US Food and Drug Administration (FDA) has granted regulatory approval to Eli Lilly (NYSE: LLY) for its interleukin-23p19 antagonist, Omvoh (mirikizumab), as a treatment for moderately to severely active ulcerative colitis (UC) in adults. This approval is a significant milestone for Eli Lilly, expanding its portfolio in the inflammatory…
-
Life Molecular Imaging and Sinotau Pharmaceutical Secure NMPA Approval for Neuraceq in China
•
Germany-headquartered Life Molecular Imaging (LMI) and China-based Sinotau Pharmaceutical Group have announced that Neuraceq (florbetaben F-18 injection) has received regulatory approval from the National Medical Products Administration (NMPA) in China. This marks a significant milestone as Neuraceq becomes the first radiopharmaceutical targeting β-amyloid approved in China to support the diagnosis…
-
MicroPort MedBot’s Toumai Robot Gains NMPA Approval for Endoscopic Surgery
•
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252), a leading medical robotics company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its Toumai endoscopic surgery robot. This approval allows the robot to be used across multiple departments for a variety of surgical…
-
EC Approves AstraZeneca and Daiichi Sankyo’s Enhertu for Advanced HER2+ NSCLC
•
The European Commission (EC) has granted registration approval for the HER2-directed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) to AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568). This approval is for the treatment of advanced HER2-positive non-small cell lung cancer (NSCLC) in adults who require systemic therapy following chemotherapy. The…
