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The first domestic drug for treating Duchenne muscular dystrophy, Angelide ® Approved for listing

On December 11, 2024, Shufang Medicine announced the announcement of Anjiali ® (Common name: Vamorolone Oral Suspension, Vamorolone); Specification: 40mg/mL, 100mL/bottle) has recently been approved by the National Medical Products Administration (NMPA) of China for the treatment of Duchenne muscular dystrophy (DMD) patients aged four years and above. Angali ® It is the first domestically approved treatment drug for Duchenne muscular dystrophy. Angali ® Previously, it was included in the breakthrough treatment drug and priority review procedures by the Drug Evaluation Center of the National Medical Products Administration.Duchenne muscular dystrophy is a rare neuromuscular disease that often occurs in childhood, and there is a huge unmet medical need in this field. Angali ® It is the first DMD treatment drug that has been fully approved in both the United States and the European Union. Its receptor that binds to glucocorticoids is the same, but its downstream activity is altered. Compared ...
- Source: drugdu
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- December 12, 2024
GLP-1 fired a shot at the AD market?

As we all know, Alzheimer’s disease is still one of the most difficult diseases in the world. The core is that the medical community still knows very little about its pathogenesis. There are currently two mainstream hypotheses about the mechanism of Alzheimer’s disease: One is the Aβ hypothesis, that is, the overexpression of β-amyloid protein (Aβ) aggregates into amyloid plaques; the other is the Tau protein hypothesis, that is, the neurofibrillary tangles formed by the misfolding of Tau protein after excessive phosphorylation. Regardless of which hypothesis, countless pharmaceutical companies have failed frequently, including the Aβ hypothesis that is most recognized by pharmaceutical companies. According to this hypothesis, the more completely the drug clears the amyloid plaques in the patient’s brain, the more beneficial it is for controlling the development of the disease. Donanemab and lecanemab, which have been approved, are the same, but the mechanisms are different. How much benefit ...
- Source: drugdu
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- December 11, 2024
China’s gene sequencing industry survives the darkest moment

When it comes to the major issue of China’s gene sequencing industry, the Biosafety Act is an unavoidable topic. At the beginning of the year, in the draft version of the Biosafety Act submitted by members of the U.S. House of Representatives, domestic companies such as WuXi AppTec, BGI, and BGI were mentioned; a similar draft bill was recently proposed by the U.S. Senate. If these bills are passed, medical institutions funded by the U.S. government will be restricted from using the products and technologies of the mentioned companies. Therefore, the Biosafety Act inevitably caused excessive panic in the domestic capital market, causing some companies to oversell. Since the “924 market”, the Science and Technology Innovation 50 has been a weather vane, with a cumulative increase of nearly 20%. Although BGI is a component of the Science and Technology Innovation 50, its stock price has fallen by nearly 40% since ...
- Source: drugdu
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- December 11, 2024
【EXPERT Q&A】Do I need to obtain authorization for the same type of medical device information?

Drugdu.com expert’s response: During the medical device registration or filing process, if the proposed referenced data for the same kind of medical device (including technical documents, clinical trial data, market usage information, etc.) are non-public, meaning these data have not been released through public channels and are protected by intellectual property rights (such as patents, trade secrets, etc.), authorization or permission from the original data holder is typically required to ensure the legitimacy and compliance of the data. This is because unauthorized use of non-public data may infringe upon the intellectual property rights of the original data holder, leading to legal disputes and regulatory risks. Therefore, when submitting a medical device registration or filing application, corresponding authorization documents or certificates should be attached to prove that the data used were legally obtained. However, if the data for the same kind of medical device are publicly published data, such as those ...
- Source: drugdu
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- December 11, 2024
Behind the sales difference between China and the United States

When it comes to innovative anesthetic sedative drugs launched in recent years, remimazolam is undoubtedly a variety worthy of attention. Remimazolam was designed and synthesized by GSK in 1999. After changing hands many times, it was approved for marketing in China, the United States, Europe and other countries almost simultaneously around 2020. However, the author found that the sales volume of the drug after its launch in different countries varies greatly. In 2023, the sales volume of remimazolam in China was about 40 million US dollars, while that in the United States was only 800,000 US dollars, which is about 2% of the Chinese market. Why is there such a difference? It is reported that remimazolam, a “new star” in the field of anesthesia, is an ultra-short-acting GABAA receptor agonist that combines the characteristics of midazolam and remifentanil, two anesthetics. Like midazolam, it acts on GABA receptors, but like remifentanil, ...
- Source: drugdu
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- December 11, 2024
Challenging the “Cancer King”

Revolution Medicines recently announced that its pan-RAS inhibitor RMC-6236 has shown significant anti-tumor effects and good safety in the treatment of patients with pancreatic ductal adenocarcinoma (PDAC) who have undergone other treatments. The study results show that RMC-6236, as a single drug for second-line treatment, can improve the median progression-free survival (PFS) and overall survival (OS) of PDAC patients carrying RAS mutations. Among them, the overall survival of patients at 6 months The rate data are impressive: 100% for patients with KRAS G12X mutations and 97% for patients with any RAS mutation. Pan-KRAS inhibitors have been making rapid progress, challenging the “king of cancers” pancreatic cancer. The toughest target? Pancreatic cancer is a malignant tumor with a high mortality rate, and RAS gene mutations have an important impact on the occurrence and development of pancreatic cancer. Data show that about 85% to 95% of pancreatic cancer patients have RAS mutations, ...
- Source: drugdu
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- December 11, 2024
580 million! Peripheral vascular innovation equipment company completes Series B financing

According to the Medicine Intelligence Data Investment Pattern Database, VFLO Medical, a peripheral vascular innovation medical device company, recently announced the completion of a Series B financing with a total amount of $80 million (approximately RMB 581 million). The financing was jointly participated by well-known investment institutions such as Tonghe Yucheng and its US dollar fund 120 Capital, a large family office, Hefei Production Investment, Hefei High tech Investment, and USTC Silicon Valley. It is reported that the funds raised in this round will be used to support the clinical and promotion of innovative pipelines in the peripheral intervention field developed by Jitong Medical through multiple collaborations and self research. The aim is to meet the huge clinical demand in China’s peripheral vascular field and bring more cutting-edge solutions for the treatment of peripheral vascular diseases. Founded in 2021, Yitong Medical is jointly incubated by Tonghe Yucheng and 120 Capital. ...
- Source: drugdu
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- December 11, 2024
GE Healthcare Swallows Japanese Nuclear Drug Giant

Recently, GE Healthcare announced that it will acquire the remaining 50% stake in Nihon Medi Physics (NMP) from Sumitomo Chemical, achieving full takeover of NMP. The transaction is expected to be completed in early 2025, subject to regulatory approval. According to Sumitomo Chemical’s announcement, this transaction is expected to bring approximately 30 billion yen (approximately 1.455 billion yuan) in revenue growth. Master of Nuclear Medicine Acquisition NMP was founded in 1973, headquartered in Tokyo, Japan, initially as a joint venture between British life sciences company Amersham and Sumitomo Chemical. Since its establishment, NMP has been committed to providing a range of radiopharmaceuticals as diagnostic agents, enabling doctors to observe the function of internal organs in the human body through imaging technology and detect the presence and progression of diseases. Nowadays, NMP has strong capabilities in molecular imaging programs such as single photon emission computed tomography (SPECT) and positron emission tomography ...
- Source: drugdu
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- December 11, 2024
Building a diversified business ecosystem, Tai’enkang’s growth ceiling is expected to be opened

Source: Daily Economic News Tai’enkang, which is accelerating its layout in the life science and health industry, has recently achieved continuous good news. Recently, the company’s CKBA ointment Phase II clinical trial completed the enrollment of all subjects. If approved for listing in the future, it is expected to become a heavyweight product of the company and create new growth points for the company. As the company focuses on innovative drugs that can break monopolies, truly address unmet clinical needs, and fill clinical gaps, building a diverse and collaborative business ecosystem will inject momentum into the long-term development of the enterprise. CKBA is making rapid progress In just one year, Taienkang has made new progress in the research and development of vitiligo drugs. Recently, Taien Kang announced that its subsidiary, Jiangsu Bochuangyuan Biomedical Technology Co., Ltd., has completed the enrollment of all subjects for the Class 1 innovative drug CKBA ...
- Source: drugdu
- 62
- December 10, 2024
Wanxiang WIL Meta ® 3D C-arm machine “and Tianzhihang” Tianji ® Orthopedic surgical robots are interconnected and interconnected

Recently, Suzhou Yimu Wanxiang Technology Co., Ltd. (hereinafter referred to as “Wanxiang Technology”) joined hands with Beijing Tianzhihang Medical Technology Co., Ltd. (hereinafter referred to as “Tianzhihang”) to discuss their core product – “WIL Meta” ® Yuanxiang Series 3D C-arm Machine “and” Tianji ® In depth communication and exploration of deep cooperation on orthopedic surgical robots. Wanxiang Technology and Tianzhihang are respectively deeply rooted in the fields of surgical imaging and orthopedic surgical robots, each with leading technological advantages and rich clinical experience. Through this collaboration, both parties will deeply combine their respective technological advantages and jointly explore new paths for smart healthcare, providing more accurate, efficient, and safe solutions for clinical practice. As the flagship product of Wanxiang Technology, WIL Meta ® The Yuanxiang series 3D C-arm machine, with its highly integrated features, ultimate compactness and lightness, fast scanning, large imaging, customized 3D, AI empowerment and other professional advantages, ...
- Source: drugdu
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- December 10, 2024

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