media – Page 19 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

The marketing application of CSPC Pharmaceutical Group’s pulgliptin metformin extended-release tablets has been accepted by the National Medical Products Administration.

On January 12, CSPC Pharmaceutical Group (1093.HK) announced that its marketing application for pruluglitin metformin extended-release tablets (hereinafter referred to as “the product”) has been accepted by the National Medical Products Administration of the People’s Republic of China (hereinafter referred to as “NMPA”) This product is a combination sustained-release formulation of our Group’s Class 1 innovative drug prulugliptin and metformin hydrochloride. It is being submitted for registration under Chemical Drug Registration Classification 2.3, with the proposed indication being (for adult patients with type 2 diabetes mellitus ( T2DM ): this product, in conjunction with diet and exercise therapy, is indicated for patients whose blood sugar is not adequately controlled by metformin monotherapy or who are currently receiving combination therapy with prulugliptin and metformin). Prulugliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. By inhibiting DPP-4, it increases the level of endogenous active GLP -1, thereby increasing glucose-stimulated insulin secretion and enhancing the ...
- Source: drugdu
- 61
- January 13, 2026
Despite a failure rate exceeding 50%, Shandong Zhitai successfully broke through and obtained the first generic drug approval.

Shandong Zhitai: Diphenhydramine Hydrochloride Injection. Recently, the NMPA (National Medical Products Administration) issued a public notice that the diphenhydramine hydrochloride injection applied for by Shandong Zhitai Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Shandong Zhitai”) has been officially approved, becoming the first company in China to pass the “deemed to have passed the consistency evaluation” for this drug . Diphenhydramine hydrochloride injection is not a new drug; it already had approval in China as early as 2002. As a first-generation antihistamine, it has a stable clinical position in the treatment of allergies, sedation, and motion sickness. However, the path to consistency evaluation for this old drug has been exceptionally bumpy. According to Yaozhi data, as of now, a total of 12 companies have submitted applications for marketing authorization or consistency evaluation for this drug to the NMPA. Of the 9 companies that have received results, 5 were rejected. A ...
- Source: drugdu
- 62
- January 13, 2026
TIHE 2026

Organiser：ITE Group, UK Time：April 28 – 30, 2026 Address：Amir Temur street, Tashkent, 700084107, Uzbekistan Exhibition hall：Uzekspocentre Exhibition Centre Product range: Pharmaceuticals, herbal preparations, nutritional supplements such as minerals and vitamins, dietary nutritional products, homeopathic preparations, dermatological preparations, maternal and infant medical care products and baby food, personal hygiene products, incontinence products, medical consumables, pharmaceuticals and pharmaceutical equipment, medical equipment, laboratory equipment and instruments, medical electronic equipment, surgical instruments, ophthalmic equipment and protective products, first-aid and emergency equipment, hospital/dental/medical service equipment About TIHE 2026 ： The Uzbekistan International Healthcare Exhibition (TIHE) is a well-known professional medical exhibition in Central Asia. It is the only medical exhibition in Uzbekistan approved by the Global Association of the Exhibition Industry (UFI). TIHE continues to be a significant event in Uzbekistan’s medical community—an authoritative and professional platform showcasing the latest global achievements in the fields of medicine and healthcare.
- Source: drugdu
- 140
- January 13, 2026
Ruizhou Biologics Announces Completion of RMB 200 Million Series B Financing, Led by Ruili Synthetic Biology Fund

In recent days, Shanghai Ruizhou Biotechnology Co., Ltd. (hereinafter referred to as “Ruizhou Biologics”) announced the successful completion of a RMB 200 million Series B financing round. This round was led by Ruili Synthetic Biology Fund, with BioTrack Capital acting as the exclusive financial advisor. The funds raised in this round of financing will be mainly used for the clinical research and commercialization advancement of the company’s core product, the 24-valent pneumococcal polysaccharide conjugate vaccine (PCV24), for indications in adults and infants/young children, as well as the R&D and pipeline development of novel meningococcal vaccines. Founded in September 2017 by Dr. Zhu Xianchao, a senior returnee expert, Shanghai Ruizhou Biotechnology Co., Ltd. (Ruizhou Biologics) focuses on the R&D and industrialization of novel vaccines, antibodies, and recombinant protein drugs. Its core product, the 24-valent pneumococcal polysaccharide conjugate vaccine, is designed for the characteristics of pathogenic pneumococcal serotypes in China. The expected ...
- Source: drugdu
- 127
- January 12, 2026
Subsidiary’s First-in-Class Long-Acting Triple Agonist DR10624 Granted Breakthrough Therapy Designation

CS Index Smart Finance — On the evening of January 11, Huadong Medicine (000963.SZ) announced that DR10624, a global first-in-class long-acting triple agonist independently developed by its majority-owned subsidiary, Zhejiang Doer Biologics Co., Ltd., has recently been included in the Breakthrough Therapy Program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The drug targets the Fibroblast Growth Factor 21 Receptor (FGF21R), Glucagon Receptor (GCGR), and Glucagon-Like Peptide-1 Receptor (GLP-1R), with the proposed indication for Severe Hypertriglyceridemia (sHTG). According to the announcement, DR10624 is a trispecific agonist targeting FGF21R, GCGR, and GLP-1R. It received clinical trial approvals from China’s CDE and the U.S. FDA in October 2023 and October 2025, respectively, for the treatment of sHTG. The Phase II clinical study results for sHTG were featured as a Late-Breaking Science presentation at the 2025 American Heart Association (AHA) Scientific Sessions. Data revealed that after 12 ...
- Source: drugdu
- 103
- January 12, 2026
Hengrui Pharma granted IND (Investigational New Drug) approvals for four drug candidates

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
- Source: drugdu
- 135
- January 12, 2026
China National Nuclear Corporation’s injectable BNCT boron drug enters clinical trial stage

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 ...
- Source: drugdu
- 124
- January 12, 2026
The National Medical Products Administration (NMPA) is accelerating the introduction of urgently needed new and effective drugs from overseas, and expanding the scope of its priority review and approval process.

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 ...
- Source: drugdu
- 106
- January 12, 2026
Lunan Pharmaceutical’s Xingda® Ruxolitinib Phosphate Tablets have been approved for marketing!

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 ...
- Source: drugdu
- 73
- January 12, 2026
Following the approval of 76 new drugs, has the year of “first launch in China” for innovative drugs begun?

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 ...
- Source: drugdu
- 250
- January 12, 2026

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