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Propafenone Hydrochloride Injection Receives Drug Production Registration Certificate

On January 30th, Shijiazhuang Pharmaceutical Group announced on the Hong Kong Stock Exchange that it had obtained the drug production registration certificate from the National Medical Products Administration of China for propafenone hydrochloride injection (20ml:70mg). This drug is classified as a Class 3 chemical drug and is considered to have passed the consistency evaluation. Shijiazhuang Pharmaceutical Group is the third domestic company to receive this approval. Propafenone hydrochloride injection is mainly used for treating supraventricular tachycardia, such as atrioventricular junctional tachycardia, WPW syndrome complicated with supraventricular tachycardia or paroxysmal atrial fibrillation, and ventricular tachycardia requiring treatment or that may be fatal.
- Source: https://finance.eastmoney.com/a/202601303636739215.html
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- January 30, 2026
Hengrui’s innovative drug camrelizumab in combination with apatinib mesylate and TACE for the treatment of liver cancer has been accepted for marketing authorization application

Recently, the National Medical Products Administration (NMPA) accepted the new indication marketing authorization applications for the innovative drugs Camrelizumab for Injection (AiRuiKa®) and Apatinib Mesylate (AiTan®) developed by Hengrui Medicine and its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd. The indication is : Camrelizumab for Injection in combination with Apatinib Mesylate and transarterial chemoembolization (TACE) for the treatment of unresectable hepatocellular carcinoma . Research on SHR-1210-III-336 This application for a new indication is based on a randomized, open-label, multicenter phase III clinical trial (SHR-1210-III-336) evaluating the efficacy and safety of camrelizumab and apatinib mesylate in combination with transarterial chemoembolization (TACE) versus TACE alone in patients with unresectable hepatocellular carcinoma. The study was led by Academician Jia Fan and Professor Shu-Kui Qin of Zhongshan Hospital affiliated with Fudan University, with participation from 34 centers nationwide, enrolling a total of 423 patients. The primary efficacy endpoint was progression-free survival (PFS) assessed by ...
- Source: https://bydrug.pharmcube.com/news/detail/e52478ede0711ec643afefcaf5bacc7a
- 52
- January 30, 2026
The world’s first clinically approved “autologous regenerated islets” for the treatment of type 2 diabetes! Ruipuchen Chuang opens a new dual-indication autologous regeneration track.

On January 29, the Investigational New Drug (IND) application for RGB-5088 pancreatic islet cell injection, independently developed by Hangzhou Ruipuchenchuang Technology Co., Ltd., for the treatment of type 2 diabetes was officially approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This is the world’s first product to utilize autologous regenerated islet therapy to treat type 2 diabetes . “Autologous regenerated islet therapy” refers to the process of creating islet cells from the patient’s own cells to replace the patient’s dysfunctional islet cells, thereby achieving long-term stable control of blood sugar levels. The islet cells created by this product not only closely resemble adult islet cells in structure and function but also possess high glucose sensitivity, allowing them to regulate insulin secretion based on changes in blood glucose concentration. It is worth noting that RGB-5088 islet cell injection has previously been approved for clinical trials in type 1 diabetes. ...
- Source: https://mp.weixin.qq.com/s/EtUZYv7EphTZ59KW-Jh9Lw
- 54
- January 30, 2026
A new player enters the market for a blockbuster drug with sales exceeding 600 million yuan, marking the second half of the battle for trazodone tablets.

Recently, according to the NMPA (National Medical Products Administration) announcement, Zhejiang Jiangbei Pharmaceutical’s trazodone hydrochloride tablets have been approved for marketing, making it the 15th company to receive approval for this product. The addition of a new competitor to an established product reflects not just a simple accumulation of approvals, but rather a rapidly accelerating, crowded race in the field of psychotropic drugs. Trazodone hydrochloride tablets, an atypical antidepressant, belong to the phenylpiperazine and triazolidine derivative class and are second-generation antidepressants of the 5-HT2 antagonist and reuptake inhibitor (SARI) class. Developed by Angelini Pharma in Italy, trazodone hydrochloride tablets are both an effective antidepressant and a good sedative-hypnotic, especially suitable for depressed patients with anxiety or sleep disorders. It was first approved for marketing in Italy on October 15, 1971, and entered the Chinese market in 2000. The market competition for trazodone hydrochloride tablets is increasingly fierce. To date, more ...
- Source: https://news.yaozh.com/archive/47035.html
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- January 30, 2026
The first of its kind in the country! A new breakthrough in the field of high-end CT

Recently, the National Medical Products Administration approved the registration application of Shanghai United Imaging Healthcare Co., Ltd. (hereinafter referred to as “United Imaging Healthcare”) for its innovative X-ray computed tomography equipment . It is understood that this product breaks through the barrier that traditional high-end CT cannot balance product coverage and temporal resolution, and promotes China’s medical imaging equipment into a new stage of development. 01 The first in the country For a long time, the high-end medical imaging equipment market has been monopolized by international giants such as GE Healthcare, Siemens, and Philips, while domestically produced equipment is mainly concentrated in the low-to-mid-end market . However, in recent years, with policy support and the trend of medical device companies continuously increasing their R&D investment, innovative medical device companies such as Wandong Medical, Neusoft Medical, and United Imaging Healthcare have continued to emerge, and more and more ...
- Source: https://news.yaozh.com/archive/47033.html
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- January 30, 2026
【EXPERT Q&A】Is it risky to register Class III medical devices?

Drugdu.com expert’s response: The registration of Class III medical devices entails significant risks, which are manifested in multiple dimensions such as technology, process, regulations, clinical trials, documentation preparation, market dynamics, and post-registration supervision. Below is a detailed analysis: High Technical Difficulty: Class III medical devices are primarily used for diagnosis and treatment, directly involving the life and health safety of patients. They have extremely high requirements for product safety and effectiveness. These products often incorporate advanced technologies such as artificial intelligence and robotics, with stringent technical standards. Ensuring product safety while meeting technical requirements poses a major challenge in the registration process. Complex Registration Process: The registration process for Class III medical devices is intricate, involving multiple stages of approval and filing, including product technical requirements, clinical trials, and quality system assessments. With increasingly stringent national reviews and regulations on Class III medical device registration, the time cost required for ...
- Source: drugdu
- 92
- January 28, 2026
The Acquisition Battle May Not Be Over

January 25th – Merck & Co. has terminated negotiations to acquire Revolution Medicines, a biotech firm focused on oncology drug research and development, The Wall Street Journal reported on Sunday. Citing people familiar with the matter, the newspaper stated that the two parties shelved the talks after failing to reach a consensus on the acquisition price. However, it does not rule out the possibility of resuming negotiations at a later date or other bidders entering the fray to bid for Revolution Medicines. At present, the above report has not been verified. Merck & Co. and Revolution Medicines could not be immediately reached for comment by the media as the announcement fell during off-hours. Earlier, at the 2026 J.P. Morgan Healthcare Conference, Revolution Medicines – which was then at the center of acquisition rumors – saw its CEO Mark Goldsmith decline to comment on any rumors or speculation surrounding potential merger ...
- Source: drugdu
- 69
- January 27, 2026
Received Approval for Clinical Trial of Yunpi Huatan Tongqiao Granules

People’s Finance News, Jan. 26: Kanion Pharmaceutical (600557) announced on Jan. 26 that it received a “Notice of Approval for Drug Clinical Trial” for Yunpi Huatan Tongqiao Granules from the National Medical Products Administration. The drug is intended to invigorate the spleen, resolve phlegm, and open orifices for treating children with adenoid hypertrophy with spleen deficiency and phlegm obstruction syndrome. While current treatments for children’s adenoid hypertrophy include nasal corticosteroids, leukotriene receptor antagonists, antihistamines, and immunomodulators, there are no approved Chinese patent medicines on the market. If successful, this product could address an unmet clinical need. https://finance.eastmoney.com/a/202601263630871910.html
- Source: drugdu
- 64
- January 27, 2026
Received Approval for Clinical Trial of Innovative Anti-tumor Drug SHR-1049 Injection

Hengrui Pharma Announcement (January 26): The company has received a “Notice of Approval for Drug Clinical Trial” from the NMPA for SHR-1049 Injection, approving clinical trials of the drug as a monotherapy for advanced solid tumors. SHR-1049 Injection is an innovative anti-tumor drug independently developed by the company, intended for the treatment of advanced solid tumors. According to current research, no similar drugs have been approved for marketing both domestically and internationally. https://finance.eastmoney.com/a/202601263630701956.html
- Source: drugdu
- 61
- January 27, 2026
North China Pharmaceutical’s tacrolimus capsules, an immunosuppressant, have received a drug registration certificate.

On January 26, North China Pharmaceutical(600812) announced that it recently obtained a Drug Registration Certificate for Tacrolimus Capsules (0.5mg, 1mg) issued by the National Medical Products Administration. This drug is a prescription drug with an 18-month shelf life, and its registration standard number is YBH35192025. This approval indicates that the product meets the relevant requirements for drug registration and possesses the basic access conditions for centralized procurement bidding. Tacrolimus is a potent immunosuppressant, primarily used to prevent graft rejection after liver or kidney transplantation. To date, excluding the original drug, eight domestic companies, including ours, hold drug registration certificates for tacrolimus capsules (0.5mg, 1mg). According to data from Yaorongyun’s full-terminal hospital database, sales of tacrolimus capsules reached 5.292 billion yuan in 2024, with a sales volume of 472 million capsules. In the first three quarters of 2025, North China Pharmaceutical Group achieved revenue of RMB 7.485 billion and net profit ...
- Source: drugdu
- 53
- January 27, 2026

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