•
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,…
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its in-house developed Category 1 chemical drug SYH2051. This ATM inhibitor will be assessed for use in general solid tumors, an indication previously approved for trials…
•
China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that a market filing for its BAT2506, a biosimilar version of Johnson & Johnson’s Simponi (golimumab), has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in the development and commercialization of this anti-TNF alpha…
•
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…
•
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for XH-S003. The company will initiate Phase II clinical studies for this Category 1 chemical drug candidate as a treatment for paroxysmal nocturnal hemoglobinuria (PNH). Mechanism and…
•
China-based Trinomab Biotech Co., Ltd announced the first delivery of its antitetanus toxin monoclonal antibody (mAb) injection Xintituo (siltartoxatug) in Zhuhai, Guangdong province. This marks a significant advancement in the treatment and prevention of tetanus, offering a more efficient and safer alternative to traditional methods. Advantages Over Traditional ProductsTraditional horse…
•
China-based Tasly Pharma Co., Ltd (SHA: 600535) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its NR-20201, an in-house developed allogeneic adipose-derived mesenchymal stromal cell-based therapy. This marks a significant step forward in the development of innovative treatments for acute ischemic stroke…
•
China’s Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) announced receiving clinical approval from the National Medical Products Administration (NMPA) for its Category 2.2 drug AD108. This modified version of Japan-based Nichi-Iko Pharmaceutical Co., Ltd’s kallidinogenase is designed to improve neurological deficits caused by acute ischemic stroke (AIS). Drug Mechanism and…
•
China Medical System Holdings (CMS; HKG: 0867) announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study evaluating the safety, tolerability, pharmacokinetics, and pharmacological characteristics of its investigational drug CMS-D003. The study will focus on healthy adults and those with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)…
•
Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for TIVDAK (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) originated by Seagen Inc., has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in making this innovative therapy available…
•
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced receiving approval from the National Medical Products Administration (NMPA) to initiate clinical studies for its Category 1 chemical drug HSK44459. The drug will be assessed for use in treating psoriasis and atopic dermatitis (AD), chronic, recurrent, and immune-inflammatory skin diseases with…
•
Partners Arvinas, Inc. (NASDAQ: ARVN) and Pfizer Inc. (NYSE: PFE) announced positive topline results from the Phase III VERITAC-2 study. The trial assessed vepdegestrant alone versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced or metastatic breast cancer who experienced disease progression following prior…
•
China’s Center for Drug Evaluation (CDE) has released the 91st batch of reference preparations for generic drug quality and consistency evaluation (GQCE). This update is part of the ongoing efforts to standardize and improve the quality of generic drugs in the country. New Additions and RejectionsThe latest batch includes 59…
•
China-based Jiuzhitang Co. Ltd (SHE: 000989) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic product, human bone marrow mesenchymal stem cells (hBMSCs), to treat autism spectrum disorder (ASD). This marks a significant step forward in exploring novel therapeutic options for ASD.…
•
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).…
•
US-based Biogen Inc. (NASDAQ: BIIB) announced the initiation of the TRANSCEND study, a global Phase III trial evaluating the efficacy and safety of its investigational drug felzartamab compared to placebo in adult kidney transplant recipients with late antibody-mediated rejection (AMR). This marks a significant step forward in addressing a critical…
•
China-based AIM Vaccine Co., Ltd (HKG: 6660) announced plans to file for market approval for its serum-free iterative rabies vaccine following the acquisition of the Drug Manufacturing License. The unblinded Phase III study results have demonstrated that the product meets the predetermined evaluation criteria for safety, immunogenicity, and immune persistence.…
•
China-based Ascletis Pharma Inc. (HKG: 1672) announced positive topline results from a Phase Ib clinical study of its ASC47 in Australia. This adipose-targeted drug candidate, developed in-house, is designed to achieve weight loss without losing muscle mass. Clinical Study ResultsIn the study, ASC47 demonstrated a half-life of up to 26…
•
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…
•
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…