media – Page 3 – Pharma & Medical Industry Insights Hub | Drugdu Insights & Updates

3D Medicines’ innovative drug Envita has been accepted by the National Medical Products Administration for marketing approval for first-line treatment of biliary tract cancer.

On January 12, it was learned from 3DMed Pharmaceuticals that its New Drug Application (NDA) for Envida (Envorimab Injection), a commercial product, in combination with gemcitabine and oxaliplatin for first-line treatment of unresectable or metastatic biliary tract cancer, has recently been accepted by the National Medical Products Administration (NMPA). This acceptance is based on the results of a Phase III clinical trial. If the NDA is successfully approved, it will become another indication for Envida. Envita is reportedly the world’s first and only approved subcutaneous PD-L1 inhibitor. As 3DMed Pharmaceuticals’ first commercialized product, Envita has achieved total sales of over 1.7 billion yuan since its launch, covering more than 3,000 hospitals and 763 pharmacies in 30 provinces across China, and has been included in the “Huiminbao” (a type of health insurance) catalog in 36 cities. Meanwhile, the company is actively expanding the commercialization of Envita in overseas markets. In 2024, ...
- Source: drugdu
- 57
- January 13, 2026
Haixiang Pharmaceutical and Wanbangde Pharmaceutical signed an innovative drug cooperation agreement focusing on the research and development of orphan drugs for ALS.

Haixiang Pharmaceutical(002099) issued an announcement stating that on January 12, 2026, the company and Wanbangde…Wanbangde Pharmaceutical Group Co., Ltd., a wholly-owned subsidiary of Pharmaceutical Holdings Group Co., Ltd. (002082), signed an ” Innovative Drug…”The two parties will collaborate on the indication of ALS (Amyotrophic Lateral Sclerosis), initially focusing on the research and commercialization of WP205, a product of Wanbangde Pharmaceuticals that has already received orphan drug designation. The agreement stipulates that Haixiang Pharmaceutical will provide a total of RMB 150 million in funding, and 15% of the cooperation profits will be distributed to Haixiang Pharmaceutical . The agreement will take effect after being reviewed and approved by the shareholders’ meeting of Wanbangde Pharmaceutical Holdings Group Co., Ltd. In the first three quarters of 2025, Haixiang Pharmaceutical achieved revenue of 1.367 billion yuan and net profit attributable to the parent company of 7.29 million yuan. https://finance.eastmoney.com/a/202601123615957442.html
- Source: drugdu
- 50
- January 13, 2026
China’s dual-resistance technology is on a roll! Rongchang RC148 secures a $5.6 billion order from AbbVie

On January 12, 2026, Rongchang Bio announced that it had granted AbbVie exclusive rights to develop, produce and commercialize its independently developed PD-1/VEGF bispecific antibody RC148 outside of Greater China. According to the announcement, AbbVie will acquire the exclusive rights to develop, manufacture, and commercialize RC148 outside of Greater China (including major pharmaceutical markets such as the United States, the European Union, and Japan). Upon the agreement taking effect, Rongchang Bio will immediately receive an upfront payment of US$650 million and will be eligible for development, regulatory, and commercialization milestone payments of up to US$4.95 billion, as well as double-digit tiered royalties based on net sales outside Greater China. The potential total value of this transaction is up to US$5.6 billion. The announcement indicates that RC148 is a novel bispecific antibody drug targeting PD-1/VEGF, developed by Rongchang Biotechnology. Its design aims to activate anti-tumor immune responses while inhibiting tumor-driven angiogenesis. ...
- Source: drugdu
- 57
- January 13, 2026
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
- 47
- 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
- 47
- January 13, 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
- 65
- 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
- 59
- 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
- 46
- 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
- 49
- January 12, 2026
Domestically produced 9-valent HPV vaccine officially launched in Chongqing

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 ...
- Source: drugdu
- 47
- January 12, 2026

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.