PharmaFocus Today – Page 23 – media

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
- 76
- 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
- 74
- 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
- 75
- 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
- 100
- 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
- 122
- 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
- 117
- 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
- 110
- 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
- 112
- January 20, 2025
Over 4.4 billion US dollars! GLP-1 opens a new chapter

There is no doubt that this is the era of GLP-1. Recently, in less than a month, three GLP-1 transactions were concluded one after another, involving an amount exceeding US$4.4 billion. First, Merck introduced the small molecule GLP-1RA HS-10535 from Hansoh Pharmaceuticals, and then Jixing Pharmaceutical introduced the global (except Greater China) development and commercialization rights of the oral small molecule GLP-1RA CX11 from Wingtech Pharmaceuticals. Recently, Verdiva Bio, an overseas Biotech company, has introduced the rights to once-weekly oral inoglutide from Xianweida Biotech. Among these transactions, a significant trend has attracted attention-the oral dosage form of GLP-1 drugs has become the focus of competition among pharmaceutical companies. Both emerging biotechnology companies and established pharmaceutical giants are all focusing their R&D resources on oral GLP-1 drugs, and a fierce competition around oral dosage forms has begun. The advantages are fully demonstrated . Currently, the mainstream GLP-1 drugs are mainly injections. ...
- Source: drugdu
- 120
- January 20, 2025
Legendary Biology’s 11 early cell therapy pipelines are advancing; Lilly GLP-1 drug sales fall short of expectations | Medical Early Reference

NO.1 Legendary Biology’s 11 Early Cell Therapy Pipelines are Advancing On January 15th Beijing time, Dr. Huang Ying, CEO of Legendary Biotech, gave a speech at the 43rd J.P. Morgan Healthcare Annual Meeting (JPM). Huang Ying introduced the progress of Legendary Biotech’s core products, core technology platforms, and research pipelines. The company has currently established a CAR-T cell therapy product portfolio that includes 11 early-stage research and development pipelines, covering multiple fields such as hematological malignancies, solid tumors, and autoimmune diseases. Comment: The report shows that Legendary Biology is advancing multiple research pipelines for autologous cell therapy/allogeneic cell therapy. These investigational therapies have a wide range of indications, not limited to multiple myeloma, but also include solid tumors such as autoimmune diseases, non Hodgkin lymphoma, small cell lung cancer, acute lymphoblastic leukemia, and hematological tumors. NO.2 Sanofi/Regenerator IL-33 monoclonal antibody has been re approved for clinical use in China The ...
- Source: drugdu
- 102
- January 17, 2025

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