PharmaFocus Today – Page 3 – media

Johnson&Johnson’s new drug, Edatinib, has been approved for market in China | Medical Early Reference

NO.1 and Huang Medicine’s new lung cancer drug, Savotinib, have been approved for new indications On January 13th, the official website of the National Medical Products Administration (NMPA) of China announced that the application for the new indication of Savotinib tablets by Hehuang Pharmaceutical has been approved. Sevotinib is a highly selective oral MET inhibitor. According to a previous press release from Hehuang Pharmaceutical, the drug has been approved for the treatment of locally advanced or metastatic non-small cell lung cancer in adult patients with mesenchymal epithelial transition factor (MET) exon 14 mutation. Comment: Hehuang Pharmaceutical has made breakthroughs in the field of innovative drugs in recent years. At the beginning of the year, the company transferred the shares of its subsidiary company that operates traditional Chinese medicine products, further focusing on innovative medicine business. Johnson&Johnson’s new cancer drug, Edatinib, has been approved for marketing in China Johnson&Johnson announced that ...
- Source: drugdu
- 54
- January 15, 2025
United Imaging Medical, there are big moves in North America

On January 9, 2025, United Imaging Healthcare officially signed an agreement to significantly expand its production and office space in the Greater Houston area. The new location in Pirlan, Texas will expand the manufacturing area of the company’s North American headquarters on Kirby Drive to more than three times its original size, and achieve an overall facility area growth of more than twice. The existing production facilities of Lianying Medical have only been in operation for over four years. 01. Internationalization Journey Lianying Medical has always been committed to internationalization, and its North American journey began more than a decade ago: In 2013, United Imaging Medical established a research and development center in Houston, USA. In 2018, United Imaging Medical participated in the annual meeting of the North American Society of Radiology and entered the North American market, with Houston becoming its regional headquarters. In 2020, the North American headquarters ...
- Source: drugdu
- 57
- January 15, 2025
Hengrui Pharmaceutical’s anti-PCSK9 monoclonal antibody has been approved for market, making it the 7th domestic product!

On January 10th, the latest announcement on the NMPA official website showed that Hengrui Pharmaceutical’s injection of Ruika Xidan Kang has been approved for marketing. The indications for this drug are: for adult patients, on the basis of controlling diet, it can be used alone or in combination with statins for other lipid-lowering therapies. It is suitable for patients with primary hypercholesterolemia (including heterozygous familial and non familial) and mixed dyslipidemia who still cannot achieve the target level of low-density lipoprotein cholesterol (LDL-C) after receiving moderate or higher doses of statins; Meanwhile, for adult patients with non familial hypercholesterolemia and mixed dyslipidemia, it can also be used as a monotherapy option to effectively reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), and apolipoprotein B (ApoB) levels. Recaticimab (SHR-1209) is an anti-PCSK9 monoclonal antibody developed by Hengrui Pharmaceutical. The drug can increase the expression of LDLR on the surface of liver ...
- Source: drugdu
- 50
- January 15, 2025
Harbour Biomed Pharmaceuticals Signs Exclusive Licensing Agreement

On January 12, Harbour Biomed Pharmaceuticals (02142) announced that it has signed an exclusive licensing agreement with Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. and Windward Bio AG for HBM9378/SKB378. According to the agreement, the licensor will grant Windward Bio a global exclusive license to manufacture, develop, use, promote, sell, promise to sell, import, and otherwise commercialize HBM9378/SKB378 outside of Greater China and several Southeast Asian and Middle Eastern countries. Under the agreement, the licensor has the right to receive up to a total of $970 million in upfront and milestone payments, as well as tiered royalties ranging from single-digit to double-digit percentages of net sales. The signing of this agreement is expected to help integrate the R&D, production, and commercialization capabilities of the licensor and Windward Bio, bringing HBM9378/SKB378 to the global market. https://finance.eastmoney.com/a/202501123294354429.html
- Source: drugdu
- 41
- January 15, 2025
TopAlliances’ Dydrogesterone Tablets Approved for General Use

Beijing Business News (Reporter Ding Ning) – On the evening of January 12, TopAlliances (688180) announced that its wholly-owned subsidiary, Shanghai Wangshi Biopharmaceutical Technology Co., Ltd., has received a “Drug Supplement Application Approval Notice” issued by the National Medical Products Administration (NMPA). The hydrochloride of Dydrogesterone Tablets (brand name: Mindev) for the treatment of adult patients with mild to moderate COVID-19 infection has been approved by the NMPA, transitioning from conditional approval to general approval. https://finance.eastmoney.com/a/202501123294345292.html
- Source: drugdu
- 54
- January 15, 2025
National Center for Nanoscience and Technology has made progress in the research of universal tumor preventive nano vaccines

Recently, the team of Zhao Ruifang and Nie Guangjun from the National Center for Nanoscience and Technology, in collaboration with the team of Han Bing from Peking University School of Stomatology, have made new progress in the research of developing universal tumor preventive nano vaccines. The relevant research results were published online in Nature Biomedical Engineering (Nature Biomedical Engineering, 2024, DOI: 10.1038/s41551-024-01309-0) with the title of Potent prophylactic cancer vaccines harnessing surface antigens shared by tumour cells and induced pluripotent stem cells. By 2030, the number of new cases of malignant tumors worldwide will reach 22 million per year, and the huge population of malignant tumor patients will bring great pressure to society. In order to reduce the burden of cancer, research on tumor preventive vaccines is in full swing. In recent years, HPV and HBV vaccines have successfully reduced the incidence of cervical cancer and liver cancer related to ...
- Source: drugdu
- 47
- January 15, 2025
Kelun Biotech’s new ADC drug “Bodu Trastuzumab” has been approved for marketing with a new indication

On January 8, the CDE official website announced that the second indication application for the Class 1 new drug Bodu trastuzumab injection submitted by Kelun Biotech has been accepted for the treatment of adult patients with HER2-positive unresectable or metastatic breast cancer who have previously received at least one anti-HER2 treatment. Bodu trastuzumab is an antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) developed by Kelun Biotech (formerly known as A166). This is the second NDA for A166. According to Kelun Biotech’s official website, based on the results of the primary analysis, A166 has reached the primary endpoint of its key Phase 2 trial for 3L+ advanced HER2-positive breast cancer and submitted its first marketing application to NMPA in May 2023. This is the second marketing application for the product, and the indication is for 2L+ advanced HER2-positive breast cancer. In addition, A166 has also conducted Phase ...
- Source: drugdu
- 45
- January 15, 2025
Deuterium hydrobromide remdesivir tablets have received routine approval from the National Medical Products Administration

On January 13th, Zhongzheng Intelligent Finance News Junshi Biotechnology (688180) announced that its controlling subsidiary, Shanghai Wangshi Biopharmaceutical Technology Co., Ltd., has obtained approval from the National Medical Products Administration to switch from conditional approval to routine approval for the listing of its drug, deuterium hydrobromide remdesivir tablets. Deuteromidevir hydrobromide tablet is used to treat mild to moderate novel coronavirus infection in adult patients (COVID-19 for short). The research results show that in mild to moderate COVID-19 patients, deuterium hydrobromide remdesivir tablets can significantly accelerate symptom relief and disappearance, shorten the course of the disease, accelerate virus seroconversion, reduce the incidence of severe COVID-19 or all-cause mortality, and have a more significant effect on elderly and high-risk patients. In patients with mild to moderate liver and kidney dysfunction, this drug has shown good safety and tolerability, and patients do not need or only need to adjust the dosage slightly ...
- Source: drugdu
- 56
- January 14, 2025
Konya once again authorized to go abroad; Oral Simeglutide Tablets Fully Launched | Medical Early Reference

Novo Nordisk announced that the world’s first oral glucagon like peptide-1 receptor agonist (GLP-1 RA), Novohexidine (semaglutide tablets), has been fully launched in China. Novosim helps patients benefit from GLP-1RA drugs earlier by convenient oral administration, bringing an innovative category for clinical treatment of type 2 diabetes in China. Comment: The oral administration of GLP-1RA, a biopeptide drug, has always been a technical challenge for scientists. Novohexin has broken through multiple absorption barriers in the stomach and pushed GLP-1 RA drugs into a new stage of oral administration. The launch of oral preparations in China will also make new contributions to the sales performance of Novo Nordisk’s “Smeaglutide Family”. NO.2 Conova CD38 monoclonal antibody “CM313” achieves external authorization Konya announced that its subsidiary has partnered with Timberlyne Therapeutics, Timberlyne, Inc. has reached an exclusive licensing agreement. Based on the licensing agreement, Konya grants Timberlyne exclusive rights to develop, produce, and ...
- Source: drugdu
- 73
- January 14, 2025
The first domestically produced one! Hengrui applies for another heavyweight drug to be listed on the market

On January 9th, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration announced that the application for the listing of SHR4640 tablets, a Class 1 new drug of Hengrui Pharmaceutical, has been accepted. SHR4640 tablets are a highly selective small molecule inhibitor developed by Hengrui Pharmaceutical for the specific expression of UraT1 (urate transporter) in renal tubular epithelial cells. It is a class 1 anti gout drug independently innovated by Hengrui Pharmaceutical and the first UraT1 inhibitor to be applied for market in China. As of now, a total of approximately 279.87 million yuan has been invested in research and development projects related to SHR4640 tablets. 01. Breaking the monopoly of imported drugs? Since the 1970s, the development of URAT1 inhibitors has been quite bumpy. In the nearly 50 years since its first appearance on the historical stage, multiple products have repeatedly gone ...
- Source: drugdu
- 68
- January 14, 2025

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