On February 28, Regeneron and Sanofi co-announced that the FDA approved the marketing application for sarilumab (brand name: Kevzara) in treating adult patients with polymyalgia rheumatica who have an inadequate response to corticosteroids (CS) or are unable to tolerate corticosteroid reduction. It is the first and only biologics approved by the FDA to treat the disease. Sarilumab is an IL-6 fully humanized monoclonal antibody.
On February 28, Cytokinetics announced that it had received a complete response letter (CRL) from the FDA regarding its new drug application (NDA) for omecamtiv mecarbil, the understudied selective and small molecule cardiac myosin activator. The FDA believes that the existing data is insufficient to support the approval of omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF).
On March 14, Futura Medical announced that it had received review comments from the FDA on the De Novo application (a way of application for a medical device) for MED3000 in treating erectile dysfunction (ED), and thus the marketing program for this product would be deferred until the second quarter of 2023. Once approved, MED3000 will be the first over-the-counter (OTC) medicine approved for and indicated in the treatment of ED.
On March 16, the NMPA official website revealed that the darolutamide (brand name: Nubeqa) of Bayer for a new indication was approved for marketing. Upon this approval, it can be used in combination with docetaxel in treating patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide is an oral androgen receptor inhibitor (ARi) co-developed by Bayer and Orion.
On March 22, Cidara announced that the FDA approved the marketing of rezafungin (brand name: rezafungin) in treating candidemia and invasive candidiasis. Previously, the FDA has granted rezafungin qualified infectious disease product (QIDP), orphan drug, and fast track designation.
On March 22, Incyte announced that the FDA approved the marketing of retifanlimab (brand name: Zynyz) in treating adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). Retifanlimab is a humanized anti-PD1 monoclonal antibody. In 2019, Zai Lab and Incyte Company announced their licensing agreement on the development and commercialization of retifanlimab in Greater China.
On March 30, the EMA official website revealed that the marketing application for semaglutide (brand name: Wegovy) submitted by Novo Nordisk had been recommended and approved by the Committee for Medicinal Products for Human Use (CHMP) for weight management in adolescents aged 12 years and older. Wegovy was approved in the United States for adult weight loss indications in June 2021. On December 23, 2022, Wegovy was approved by the FDA to expand the applicability to adolescents aged 12 years and older based on positive results from the phase III STEP TEENS study. As the target users of Wegovy are expanding, its sales volume is expected to grow even further in 2023.
NMPA
On March 1, the NMPA official website revealed that Sino Biopharm's palbociclib capsules were approved for marketing. Palbociclib, the first approved CDK4/6 inhibitor in the world, can selectively inhibit CDK4/6, restore cell cycle control, and block tumor cell proliferation. The approved indication is locally advanced or metastatic breast cancer with hormone receptor (HR) - positive and human epidermal growth factor receptor 2 (HER2) - negative. The product should be used in combination with aromatase inhibitors as initial endocrine therapy for postmenopausal female patients.
On March 1, the NMPA official website revealed that Sino Biopharm's tedizolid phosphate tablets and tedizolid phosphate for injection were approved for marketing. Tedizolid is a second-generation oxazolidinone antibiotic indicated for acute bacterial skin and skin structure infections in adults caused by specific susceptible bacteria. As a prodrug, tedizolid phosphate can be rapidly converted in vivo by phosphatases into biologically active tertiazolamide, which binds to the ribosomal 50S subunit of bacteria, thereby inhibiting protein synthesis.
On March 3, the NMPA official website revealed that Hengrui Pharmaceuticals' first-in-class new drug, adebrelimab injection, was approved for marketing to be used in combination chemotherapy for the first-line treatment of extensive-stage small cell lung carcinoma. Adebrelimab, a humanized anti-PD-L1 monoclonal antibody self-developed by Hengrui Pharmaceuticals, can specifically bind to the PD-L1 molecule and then block the PD-1/PD-L1 pathway that leads to tumor immune tolerance and reactivate the antitumor activity of the immune system, thereby achieving the goal of treating tumors.
On March 3, the NMPA official website revealed that the trastuzumab biosimilar HS022 of Hisun Biomaterials, a wholly-owned subsidiary of BioRay, was approved for marketing to treat HER2-positive metastatic breast cancer, early gastric cancer, and metastatic gastric cancer. The innovator product of trastuzumab is Roche Herceptin, which has previously been approved in China for the treatment of breast cancer and gastric cancer.
On March 3, the NMPA official website revealed that Chiatai Tianqing's bevacizumab biosimilar TQB2302 was approved for marketing. Bevacizumab is a vascular endothelial growth factor (VEGF) inhibitor. The innovator drug, Roche Anvitin, has been approved in China for the treatment of indications including non-small cell lung carcinoma (NSCLC), metastatic colorectal cancer, glioblastoma, hepatocellular carcinoma, ovarian cancer, and cervical cancer.
On March 16, the NMPA official website revealed that Everest Medicines' first-in-class eravacycline (brand name: Xerava) was approved for marketing. Its indication is complicated intra-abdominal infections in adults. Eravacycline is a novel, fully synthetic, broad-spectrum, fluorotetracycline-containing, intravenous antibiotic that has been approved for marketing in the United States, EU, UK, and Singapore.
On March 22, the NMPA official website revealed that CSPC Pharmaceutical Group's SYS6006 was included in emergency use for the prevention of diseases caused by coronavirus disease 2019 (COVID-19). It is the first mRNA vaccine that has been self-developed and authorized for emergency use in China. It has now completed phases I and II and sequential booster immunization clinical research in China, with safety, immunogenicity, and protective potency demonstrated by the results of clinical research in more than 5,500 individuals.
On March 22, the NMPA official website revealed that SinoCellTech's recombinant COVID-19 quadrivalent (Alpha/Beta/Delta/Omicron variant strain) S trimeric protein vaccine (project code number: SCTV01E) was included in emergency use for the prevention of diseases caused by COVID-19. SCTV01E is the second COVID-19 vaccine product of SinoCellTech that was included in emergency use by China.
On March 22, the NMPA official website revealed that Aosaikang's ceritinib capsules were approved for marketing. It is the first marketed generic drug of Aosaikang. Ceritinib is an anaplastic lymphoma kinase (ALK) inhibitor originally manufactured by Novartis and AstraZeneca. In May 2018, ceritinib was approved for marketing in China for the treatment of patients with ALK-positive metastatic NSCLC whose disease progresses after receiving crizotinib therapy or who are intolerant to crizotinib.
On March 23, the NMPA official website revealed that AstraZeneca's acalabrutinib capsules (brand name: Calquence) were approved for marketing with conditions to treat adult mantle cell lymphoma (MCL) patients with at least one prior therapy. Acalabrutinib is a next-generation BTK inhibitor with high selectivity. It has been approved for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the United States, CLL in the EU and many other countries worldwide, and relapsed or refractory CLL and SLL in Japan.
On March 27, the NMPA official website revealed that Eli Lilly's baricitinib tablets (brand name: Olumiant) were approved for marketing for the systemic treatment of severe alopecia areata in adults. Baricitinib tablets are the first and only innovative targeted drug for the systemic treatment of severe alopecia areata in China. Baricitinib, a once daily oral JAK inhibitor, was originally developed by Incyte.
On March 27, the NMPA official website revealed that CSPC Pharmaceutical Group's apremilast tablets were approved for marketing. It is the first apremilast generic drug approved for marketing in China. Apremilast is an oral small molecule phosphodiesterase 4 (PDE4) inhibitor developed by Amgen that can effectively alleviate psoriasis system inflammation by increasing intracellular cAMP (cyclic adenosine monophosphate) levels.
On March 31, the NMPA official website revealed that T-mab Bio's denosumab injection (brand name: 迈利舒) was approved for marketing to treat osteoporosis in postmenopausal women at high risk of fracture; the product significantly reduces the risk of vertebral, nonvertebral, and hip fractures in postmenopausal women. It is the second Prolia biosimilar approved for marketing worldwide. Denosumab is an IgG2 fully-humanized monoclonal antibody that was originally developed and marketed by Amgen.
On March 27, Amicus Therapeutics announced that the European Commission (EC) approved cipaglucosidase alfa (brand name: Pombiliti) for marketing in combination with miglustat for the treatment of late-onset Pompe's disease (LOPD) in adults. Cipaglucosidasealfa is an enzyme replacement therapy with recombinant human acidic α- Glucosidase (rhGAA) featuring optimized carbohydrate structure.
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Pharma Sources Insight JANUARY 2024
