PharmaFocus Today – Page 5 – media

Isaconazole sulfate API approved for market launch, expanding into the antifungal drug field

Shanghai Pharmaceuticals (601607) announced on the evening of January 13 that its subsidiary, Shanghai Pharmaceutical Kangli (Changzhou) Pharmaceutical Co., Ltd., received the ” Chemical Raw Material ” certificate for isaconazole sulfate raw material issued by the National Medical Products Administration.The drug was officially approved for production upon receiving the “Notification of Approval for Drug Marketing Application”. The announcement indicates that isaconazole sulfate is an azole antifungal drug and a prodrug of isaconazole. After entering the body, it is rapidly converted into the active metabolite isaconazole by plasma esterases, which disrupts fungal cell membrane formation by inhibiting ergosterol biosynthesis. This drug was jointly developed by Astellas Pharma and Basellia Pharma, and was approved for marketing in the United States in 2015 for the treatment of invasive aspergillosis and mucormycosis in adults. It has been granted orphan drug status in both the European Union and the United States. Shanghai Pharmaceuticals Kangli submitted ...
- Source: drugdu
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- January 14, 2026
WuXi Biologics Receives UK MHRA GMP Certification, Accelerating Commercial Production of Innovative Ophthalmic Biologics

WuXi Biologics recently announced that its two manufacturing plants in Wuxi—Plant 5 (DP5) and the Formulation Packaging Centre (DPPC)—have received GMP certification from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to provide commercial manufacturing services for an innovative ophthalmic biologic. WuXi Biologics will provide end -to-end manufacturing services for this ophthalmic biologic, covering both the drug substance and the formulation. https://finance.eastmoney.com/a/202601133616465680.html
- Source: drugdu
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- January 14, 2026
NVIDIA and Eli Lilly jointly invested 1 billion US dollars to establish an AI drug research laboratory

China Securities News (Intern Yang Yanying, Reporter Wang Zhoujie) – On January 12th local time, NVIDIA and the pharmaceutical company Eli Lilly announced that they would jointly invest 1 billion US dollars to establish an AI drug research laboratory in San Francisco to accelerate the drug development process. This 1 billion US dollar investment will be used over five years for the infrastructure, computing power and talent deployment of the laboratory. Engineers from NVIDIA will collaborate with experts in biology, science and medicine from Eli Lilly to advance medical research. The related work of the laboratory will start at the beginning of this year. Eli Lilly’s CEO David Ricks said, “Combining our vast data and scientific knowledge with NVIDIA’s computing capabilities and model construction expertise may completely reshape the way we know drug development.” In the medical and health field, NVIDIA has previously invested in the biotechnology company Recursion and ...
- Source: drugdu
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- January 13, 2026
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
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- 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
- 51
- 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
- 58
- 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
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- 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
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- 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
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- 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
- 70
- January 12, 2026

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