Beijing Business Today — On Jan. 9, Jiangsu Hengrui Pharmaceuticals Co., Ltd. released an announcement stating that the company and its subsidiaries (Chengdu Shengdi Pharma and Shanghai Hengrui Pharma) have obtained IND (Investigational New Drug) approvals from the NMPA for SHR-4394 (for injection), HRS-5041 tablets, Zemetostat (SHR-2554), and Rezvilutamide. The upcoming clinical program features a multicenter, open-label Phase II trial investigating SHR-4394 or HRS-5041 combined with anti-tumor therapies for the treatment of prostate cancer, focusing on safety, tolerability, and efficacy. https://finance.eastmoney.com/a/202601093614353893.html
On January 9, a clinical collaboration project on boron neutron capture therapy (BNCT), jointly undertaken by CNNC Haidewei, Fujian Ruisco, and Fujian Medical University Union Hospital, was officially launched in Putian, the hometown of Mazu in Fujian. According to CNNC Haidewei, the injectable boron[10B] phalan, independently developed by CNNC Haidewei, recently received the “Drug Clinical Trial Approval Notice” from the National Medical Products Administration, marking the official entry of the drug into the Phase I clinical trial stage. Boron neutron capture therapy (BNCT) is a novel radiotherapy method that precisely targets cancer cells. Its principle is based on the specific affinity of boron-10 compounds for cancer cells. After the drug accumulates at the tumor site, neutron beam irradiation triggers a boron neutron capture nuclear reaction, thereby precisely destroying tumor cells while maximally protecting surrounding normal tissues. This represents a highly promising frontier in the field of cancer treatment. CNNC Haidewei ...
To accelerate the introduction of effective and innovative drugs from overseas and fill unmet clinical needs of domestic patients, in addition to new drugs for major and rare diseases, urgently needed drugs already marketed overseas for the treatment of chronic and geriatric diseases can now be included in the priority review and approval scope of the National Medical Products Administration (NMPA). Furthermore, for eligible generic drugs already marketed overseas, clinical trials may be waived, allowing pharmaceutical companies to directly submit applications for marketing authorization. On January 7, the National Medical Products Administration (NMPA) issued the “Announcement on Further Optimizing the Review and Approval of Clinically Urgent Drugs Already Marketed Overseas” (hereinafter referred to as the “Announcement”). The Announcement reiterated the principle of “adhering to clinical value as the guiding principle and encouraging applicants to conduct simultaneous global research and development and apply for market approval in China,” while clarifying that ...
Recently, Xingda® Ruxolitinib Phosphate Tablets (specifications: 5mg (calculated as C17H18N6), 20mg (calculated as C17H18N6)) produced by Shandong New Era Pharmaceutical Co., Ltd. of Lunan Pharmaceutical Group were approved for marketing by the National Medical Products Administration and are regarded as having passed the consistency evaluation of generic drug quality and efficacy. Approval numbers: National Drug Approval Number H20263015 and National Drug Approval Number H20263014. Ruxolitinib is a highly potent and selective inhibitor of Janus-associated kinases (JAK family) JAK1 and JAK2. It is indicated for the treatment of disease-related splenomegaly or disease-related symptoms in adult patients with intermediate- or high-risk primary myelofibrosis (PMF) (also known as chronic idiopathic myelofibrosis), myelofibrosis secondary to polycythemia vera (PPV-MF), or myelofibrosis secondary to essential thrombocythemia (PET-MF); and for the treatment of acute graft-versus-host disease (acute GVHD) or chronic graft-versus-host disease (chronic GVHD) in patients aged 12 years and older with an inadequate response to glucocorticoids ...
At the turn of the year, the National Medical Products Administration set the tone for innovation in China’s pharmaceutical industry in 2026 with a series of intensive actions. Following New Year’s Day, the National Medical Products Administration (NMPA) announced significant achievements for 2025, including the approval of 76 innovative drugs and a total transaction value exceeding US$100 billion for overseas authorizations . Subsequently, at the National Drug Supervision and Management Work Conference held on January 6, NMPA Director Li Li further clarified the policy direction: China will strengthen service support for innovative drugs with new mechanisms and new targets across the entire chain, including communication, clinical trials, registration applications, and review and approval, to help innovative drugs achieve “first launch in China” . This vision of “first launch in China” goes far beyond the geographical significance of “innovative drugs being launched in China first.” It points to the deeper value ...
Recently , the domestically produced nine-valent HPV vaccine campus health initiative took a solid step forward at Chongqing University – the first vaccination ceremony of “Wholehearted Protection, Walking with You in Chongqing” was officially launched at Campus A of Chongqing University’s Shapingba Campus. As the second stop in the national university promotion sequence, this event was hosted by the Shapingba District Center for Disease Control and Prevention and organized by Chongqing University Hospital and Xiamen Wantai Canghai Biotechnology Co., Ltd., marking the official launch of China’s independently developed nine-valent HPV vaccine, Xinkening 9, in Chongqing , providing more comprehensive, convenient and accessible cervical cancer protection options for women aged 9 to 45 in the city. This vaccine is China’s first and the world’s second approved nine-valent HPV vaccine . It received NMPA approval in June 2025, ending the previous reliance on imports for the nine-valent vaccine. Compared to the bivalent ...
On January 8th, Xianju Pharmaceutical…(002332) issued an announcement stating that the company recently received the “Drug Registration Certificate” for betamethasone sodium phosphate injection issued by the National Medical Products Administration. The specification of betamethasone sodium phosphate injection is 1ml:4mg (calculated as CHFO), and it is submitted for approval as a Class 3 chemical drug. The reference preparation for this drug is betamethasone sodium phosphate injection marketed in the European Union, under the brand name Celestone®. In the first three quarters of 2025, Xianju Pharmaceutical achieved revenue of RMB 2.826 billion and net profit attributable to the parent company of RMB 407 million. https://finance.eastmoney.com/a/202601083613015592.html
Recently, OpenAI released two AI products related to the healthcare field: ChatGPT Health for consumers and OpenAI for Healthcare for medical institutions. ChatGPT Health, integrated into ChatGPT, is a “dedicated space for health-related conversations with ChatGPT.” It connects to electronic medical records and various health applications, generating responses that incorporate the user’s health information and personal context. OpenAI for Healthcare is a suite of products designed to help healthcare institutions provide more consistent and higher-quality care to patients. It can be used to create reusable discharge summaries and patient guidance templates, or to analyze medical evidence for application to specific patients. https://finance.eastmoney.com/a/202601093613575432.html
On January 7th local time, the British pharmaceutical company GlaxoSmithKline…GSK announced that its investigational chronic hepatitis B therapy, Bepirovirsen, met its primary endpoints in two pivotal Phase 3 clinical trials. If approved, this would mean the world’s first antiviral therapy that can achieve functional cure of hepatitis B with only a limited 6-month treatment course. Bepirovirsen is a novel antisense oligonucleotide (ASO) antiviral therapy for hepatitis B that directly inhibits viral replication. GSK plans to formally initiate global regulatory approval applications for Bepirovirsen in the first quarter of this year. The term “functional cure” refers to a condition where, after discontinuing medication, the patient remains negative for hepatitis B surface antigen (HBsAg) and has undetectable hepatitis B virus (HBV) DNA for six months or longer. Analysts believe that even if only 15% to 20% of hepatitis B patients achieve functional cure, it will have significant implications for changing global hepatitis ...
Recently, Xuantai Pharmaceutical received a Drug Registration Certificate issued by the National Medical Products Administration, officially approving the marketing of its independently developed “Isaconazole Sulfate for Injection ,” bringing new hope for the treatment of fungal infections in China! Targeting essential clinical needs and enriching the product pipeline The newly approved isaconazole sulfate for injection is an injectable formulation with a strength of 0.2g (calculated as C₂₂H₁₇F₂N₅OS), indicated for the treatment of invasive aspergillosis and invasive mucormycosis in adults . These two types of infections are serious invasive fungal infections, posing a significant threat to high-risk groups such as those with weakened immune systems, and there is an urgent clinical need for their treatment. It is understood that the original drug was developed by Pfizer and was quickly included in the National Reimbursement Drug List (NRDL) after being approved in China in June 2022. It has gained widespread clinical recognition ...
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