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Huadong Medicine’s exclusive marketing product Cenaparib Capsules (Paisuning®) has been approved for marketing by NMPA

Recently, Hangzhou Sino-US Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “Sino-US Huadong”), a wholly-owned subsidiary of Huadong Medicine Co., Ltd. (hereinafter referred to as “the Company”), has obtained the approval of the National Medical Products Administration (NMPA) for the exclusive marketing product Cenaparib Capsules (trade name: Paisuning®, research and development code: IMP4297) for marketing, which is used for maintenance treatment of adult patients with advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer after achieving complete remission or partial remission of first-line platinum-containing chemotherapy. About Cenaparib On December 19, 2023, Sino-US Huadong and Shanghai Yingpai Pharmaceutical Co., Ltd. (hereinafter referred to as “Yingpai Pharmaceutical”), a wholly-owned subsidiary of Nanjing Yingpai Pharmaceutical Co., Ltd., signed an exclusive marketing service agreement. Sino-US Huadong obtained Yingpai Pharmaceutical’s exclusive marketing rights for Cenaparib in mainland China. Cenaparib is a novel, highly effective PARP1/2 inhibitor independently developed by Impa Pharmaceuticals. It has ...
- Source: drugdu
- 252
- January 22, 2025
Domestic new drugs are popular, and some people are falling behind

In the second half of 2024, domestic TCE bispecific antibody transactions are popular all over the world, and autoimmune-related transactions account for 5 of all 7 domestic TCE bispecific antibody transactions, which can be called the “hottest” type of domestic innovative drugs. It is in this wave of global pharmaceutical companies scrambling for autoimmune TCE bispecific antibody rights that some developers have begun to fall behind, and the most advanced overseas biotech company IGM Biosciences. On January 9, IGM Biosciences announced that the company will lay off 73% of its employees and stop developing two autoimmune candidate drugs, Imvotamab (CD3/CD20 bispecific antibody) and IGM-2644 (CD3/CD38 bispecific antibody). IGM made such a decision because its CEO Mary Beth Harler said that the interim data of the Phase Ib study of Imvotamab in the treatment of rheumatoid arthritis and systemic lupus erythematosus showed that the depth and consistency of B cell depletion ...
- Source: drugdu
- 242
- January 22, 2025
Kelunbotai’s PD-L1 monoclonal antibody “Tagolimab” has been approved for a new indication

On January 20, 2025, Kelunbotai’s Tagolimab injection was approved by the State Food and Drug Administration again, with a new indication of first-line treatment of recurrent or metastatic nasopharyngeal carcinoma in combination with gemcitabine and cisplatin (acceptance number CXSS2400049). The approval of this new indication marks a further expansion of the application scope of Tagolimab in the treatment of nasopharyngeal carcinoma. Nasopharyngeal carcinoma is a malignant tumor that occurs in the nasopharynx. Because its location is hidden and its early symptoms are not obvious, it is often diagnosed in the middle and late stages. https://bydrug.pharmcube.com/
- Source: drugdu
- 213
- January 22, 2025
Innovent Biologics enters a new era of dual-wheel drive and global innovation and development

January 17, 2025, San Francisco, USA and Suzhou, China – Innovent Biologics (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, production and sale of innovative drugs in major disease areas such as oncology, autoimmunity, metabolism, ophthalmology, etc., was invited to attend the 43rd Annual JPMorgan Healthcare Conference (JPM). Dr. Yu Dechao, founder, chairman and CEO of the group, delivered a keynote speech on site to share the company’s latest business progress and prospects. In its 13 years of establishment, Innovent Biologics has grown rapidly into a leading biopharmaceutical company in China. Under the guidance of the “sustainable development and global innovation” strategy, it has continuously achieved excellent results. At the beginning of the new year, the company has made important progress: two lung cancer targeted drugs, Dabolu® and Aoyixin®, were approved in succession, and the number of commercial products increased to 14; Xinbilu® was included in the medical ...
- Source: drugdu
- 326
- January 22, 2025
【EXPERT Q&A】Why does IVD analysis performance evaluation require the use of samples from different sources for research?

Drugdu.com expert’s response: In the analytical performance evaluation of IVD (In Vitro Diagnostics), the requirement to use samples from different sources for research is primarily based on the following considerations: I. Influence of Matrix Effects For IVD products, the detection targets are typically human tissues or fluids, particularly liquid samples such as blood and urine. These samples contain various substances such as salts, proteins, lipids, etc., which collectively constitute the matrix of the sample. Different human samples, or even samples from the same individual at different time points, may exhibit variations in their matrices. This matrix variation can impact the test results of reagents, known as matrix effects. Matrix effects are objectively present but can be controlled through scientific methods. Therefore, when conducting analytical performance evaluations of IVD products, it is necessary to use samples from different sources as much as possible to fully consider the impact of matrix effects ...
- Source: drugdu
- 332
- January 22, 2025
14 breakthrough devices approved for market launch

The FDA’s Breakthrough Devices Program is a voluntary program aimed at accelerating the review of breakthrough technologies or technologies that can more effectively treat or diagnose life-threatening or irreversible debilitating diseases or conditions. According to data from PharmSmart Medical Devices, there are a total of 32 breakthrough device products that have been approved for market by the US FDA in 2024. According to publicly available information from the FDA, the types of 32 products are mainly focused on passive implantable devices, with orthopedic and cardiovascular implants being the main ones. This article introduces 14 types of implantable devices, as follows: 01. Chest and Abdominal Branch Stent (W.L. GORE&ASSOCYTES, INC.) Indications: Patients with thoracoabdominal aortic aneurysm, as well as those with high surgical risk and proximal renal aortic aneurysm. The main researcher of this product, Dr. Michel Makarou, director of vascular surgery at the University of Pittsburgh School of Medicine, stated ...
- Source: drugdu
- 740
- January 21, 2025
Meditex Bangladesh

Organiser：CEMS Exhibitions USA Time：May 8 – 10, 2025 Address：Agargaon, Sher-E-Bangla Nagar, Dhaka – 1207, Bangladesh. Exhibition hall：Bangabandhu International Conference Center Product range: Hospital medical equipment, appliances, disposable consumables, surgical equipment and accessories, surgical instruments, physiotherapy equipment, orthopedic equipment. Plastic surgery equipment, prosthesis materials, repair materials, healthcare equipment, electronic medical devices, medical technology, testing and diagnostic equipment, treatment equipment, dental equipment and supplies, laboratory equipment. Professional medical uniforms, emergency equipment, hospital supplies, hospital furniture, communication devices, control and automation systems, medical service providers and related services, technologies, and equipment. Pharmaceuticals, prescription drugs, herbal preparations, nutritional health supplements such as minerals and vitamins, dietary nutritional products, etc. About Meditex Bangladesh： Meditex Bangladesh is the highest-level exhibition of medical equipment and supplies in Bangladesh. Numerous exhibitors showcase a wide variety of medical equipment, conduct business, and stay updated on the latest developments in the pharmaceutical industry.
- Source: drugdu
- 699
- January 21, 2025
Zhengda Tianqing challenges Microchip Biotechnology alone, original anti-cancer drugs are challenged for patent invalidation, and cumulative sales exceed 2.3 billion

Domestic original anti-cancer drugs encounter patent challenges. On January 16, Microchip Biotechnology (688321.SH) issued an announcement stating that on December 30, 2024, Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhengda Tianqing”) filed a request for invalidation of the company’s cedabendamine product patent with the State Intellectual Property Office. After formal review, the State Intellectual Property Office issued a “Notice of Acceptance of Invalidation Request” on January 13, 2025. According to the announcement, the patent involved in the case is an invention patent for “an E-configuration benzamide compound and its pharmaceutical preparation and application” (patent number: ZL201410136761.X). This patent is one of the series of patents that ChipScreen Biotech has laid out for its product line of ChipScreen Biotech, which was applied for by ChipScreen Biotech to the State Intellectual Property Office on April 4, 2014, and was authorized on May 17, 2017. The patent is valid until ...
- Source: drugdu
- 357
- January 20, 2025
the national alliance centralized procurement is coming, which may stir up the biosimilar market

On January 16, the share price of Innovent Biologics (HK01801, share price 30 Hong Kong dollars, market value 49.14 billion Hong Kong dollars) fell by more than 10%, with the largest drop exceeding 14%. The market view generally links the drop in share price to a meeting two days ago. According to the official website of the Anhui Provincial Medical Security Bureau, on January 14, the provincial medical security work conference was held in Hefei. The meeting made arrangements for the provincial medical insurance work in 2025 from seven aspects, of which the third article mentioned “leading the national biological drug alliance centralized procurement”. It is reported that chemical drugs are usually also called small molecule drugs, with simple chemical structures. As long as the chemical structures are consistent, the active ingredients are generally considered to be the same. Biological drugs are usually called macromolecular drugs, but due to their ...
- Source: drugdu
- 357
- January 20, 2025
The first major pharmaceutical merger in 2025

On January 13, Johnson & Johnson announced that it had reached a final agreement with Intra-Cellular Therapies to acquire all outstanding shares of the latter at a price of US$132 per share, with a total transaction value of approximately US$14.6 billion. Intra-Cellular Therapies is a biopharmaceutical company focused on the development and commercialization of drugs for the treatment of central nervous system (CNS) diseases. Its core asset is a once-daily oral antipsychotic product Caplyta (lumateperone). The drug is a 5-hydroxytryptamine 2A (5-HT2A) receptor antagonist and dopamine receptor D2 modulator, first developed by Bristol-Myers Squibb (BMS). In 2015, Intra-Cellular Therapie obtained a license from BMS for global development. In December 2019, Caplyta was approved by the FDA for the treatment of adult patients with schizophrenia, and in December 2021 it was approved for the adjuvant treatment of depressive episodes associated with bipolar disorder type I or type II (bipolar depression). In ...
- Source: drugdu
- 334
- January 20, 2025

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