PharmaFocus Today – Page 26 – media

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
- 70
- 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
- 92
- 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
- 99
- 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
- 97
- January 14, 2025
One innovative medical device approved for market launch

Recently, the National Medical Products Administration approved the registration application for the innovative product “intraocular lens with crystalline lens” of Abonod (Beijing) Medical Technology Co., Ltd. (hereinafter referred to as Abonod). Heavy product, breakthrough innovation Established in 2010, iBonod is an innovation driven manufacturer of ophthalmic medical devices, covering three major areas: ophthalmic surgical treatment, myopia prevention and control, and vision health care. We strive to provide one-stop solutions for cataract surgery, refractive error correction, and optical consumption. It is worth mentioning that iBonod successfully listed on the Science and Technology Innovation Board on July 29, 2020, becoming the first ophthalmic medical device company in China to complete the listing on the board. The company is based on three core products: artificial intraocular lenses, corneal reshaping lenses, and contact lenses. The company has strategically expanded its coverage of the entire lifecycle product pipeline for eye health. After years of development, ...
- Source: drugdu
- 92
- January 14, 2025
Sansure Biotech Plans to Acquire 100% Equity of Zhongshan Haiji

Beijing Business News (Reporter Ding Ning) – On January 11, Sansure Biotech (688289) announced that the company intends to acquire 100% equity of Zhongshan Weiming Haiji Biopharmaceutical Co., Ltd. (hereinafter referred to as “Zhongshan Haiji”) for 807.5 million yuan. Sansure Biotech stated that Zhongshan Haiji has certain production capacity in the areas of recombinant proteins, peptide technology platforms, as well as overall industrial microbiology and synthetic biology, which can create a synergistic development with the company in the field of functional biomedicine products. In the future, the company will continue to leverage the strengths of both parties to provide technical support and collaborative innovation for the research projects related to growth hormones. Additionally, the expertise in diagnostics can offer necessary validation and feedback support for the ongoing optimization and iteration of growth hormone products. https://finance.eastmoney.com/a/202501123294309388.html
- Source: drugdu
- 93
- January 14, 2025
Confident in China’s Economic Outlook and Development in China, Will Continue to Deepen Commitment to the Chinese Market

On January 9, Ambassador Wang Xuefeng of Denmark met with Lars Fruergaard Jørgensen, Global President and CEO of Novo Nordisk. Ambassador Wang stated that cooperation in the biopharmaceutical and health industry between China and Denmark has been strong, with Novo Nordisk achieving fruitful results in its decades-long partnership with China, leading to mutual benefits. Last July, the 20th Central Committee of the Communist Party of China proposed major reform measures to improve the support mechanism for the development of innovative drugs and medical devices. The Central Economic Work Conference held in December signaled ongoing deepening of reforms and an expansion of high-level opening-up policies. Recently, the Chinese government issued guidance on the high-quality development of the pharmaceutical industry, creating vast opportunities for leading global pharmaceutical companies like Novo Nordisk to develop in China. Ambassador Wang expressed hope that Novo Nordisk would take the occasion of the 75th anniversary of diplomatic ...
- Source: drugdu
- 81
- January 14, 2025
Lowers Novo Nordisk’s Target Stock Price to 875 Danish Krone

Securities Times Network reports that Goldman Sachs has lowered the target stock price for Novo Nordisk to 875 Danish krone (approximately $102.5), but still maintains a “buy” rating. This move is not an isolated case, as both BNP Paribas and Jyske Bank have also reduced their target prices while maintaining an outperform or buy rating. Novo Nordisk’s stock price has fluctuated significantly recently, with some investors expressing disappointment over the performance data of its weight loss drugs. Additionally, UK-based Hikma Pharmaceuticals has received FDA approval to launch a generic version of Novo Nordisk’s diabetes injection, increasing competitive pressure in the market. https://finance.eastmoney.com/a/202501133294434240.html
- Source: drugdu
- 73
- January 14, 2025
No Resistance Found for Baloxavir in China

Roche Pharmaceuticals released a statement saying, “No resistance has been found for Baloxavir in China.” According to authoritative monitoring reports from the World Health Organization (WHO) and the National Centers for Disease Control, Baloxavir currently remains effective against various influenza viruses globally. In China, no strains of the influenza virus exhibiting resistance to Baloxavir have been discovered. The latest data from WHO on the monitoring of antiviral drug-resistant strains show that both Type A and Type B influenza viruses remain sensitive to neuraminidase inhibitors (such as Oseltamivir) and RNA polymerase inhibitors (such as Baloxavir), and treatment remains effective. https://finance.eastmoney.com/a/202501123294373814.html
- Source: drugdu
- 67
- January 14, 2025
36 billion! Stryker swallows up the “peripheral” giant

On January 6, Stryker announced that it would acquire peripheral giant Inari Medical for $80 per share in cash, with a total transaction value of approximately $4.9 billion (approximately RMB 36 billion). The two companies expect to complete the transaction by the end of the first quarter of 2025, but it is subject to the tender of most of Inari’s outstanding shares, regulatory approval and other customary conditions. At the beginning of 2025, the merger and acquisition king Stryker “re-emerged” and threw in a large acquisition case. Behind the first acquisition of the year is the signal that Stryker has officially entered the peripheral vascular market. Why premium acquisitions are favored It is reported that Stryker’s acquisition was a premium acquisition. Before the transaction was announced, Inari Medical’s stock price was about $48, but the actual official acquisition announcement showed that Stryker acquired it at $80 per share in cash. ...
- Source: drugdu
- 94
- January 13, 2025

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