PharmaFocus Today – Page 8 – media

The first subject has been dosed in the Phase II clinical trial of its innovative small nucleic acid drug EDP167.

On February 9, Yiteng Jiahe (06998) issued an announcement, announcing that its innovative small nucleic acid drug…The first subject was successfully dosed in the Phase II clinical trial of EDP167. This trial is aimed at adult patients with homozygous familial hypercholesterolemia (HoFH) and aims to evaluate the efficacy and safety of EDP167 in HoFH patients. The primary endpoint is the change in low-density lipoprotein cholesterol (LDL-C) levels from baseline 24 weeks after the first dose. The evaluation of the primary endpoint is expected to be completed in the fourth quarter of 2026. EDP167 is an innovative siRNA therapy specifically designed to treat dyslipidemia. Its mechanism of action is independent of the LDL receptor pathway, overcoming the limitations of traditional lipid-lowering drugs. Prior to initiating a Phase II clinical trial for HoFH patients, the company completed a Phase I clinical study in healthy individuals and those with mild dyslipidemia. Results showed ...
- Source: drugdu
- 60
- February 12, 2026
Novo Nordisk’s oral weight-loss drug advertisement has been flagged by the FDA for allegedly misleading advertising.

According to the U.S. Food and Drug Administration (FDA), Danish pharmaceutical company Novo Nordisk…For oral weight loss drugsA television advertisement was found to contain “false or misleading” claims. Novo Nordisk is the manufacturer of semaglutide, a drug that is also produced by Eli Lilly.Tirzepatide is a GLP-1 weight loss drug . In January of this year, the oral version of semaglutide was approved for marketing in the United States, becoming the world’s first oral GLP-1 inhibitor for the treatment of obesity. Novo Nordisk stated last week that more than 170,000 patients in the United States are currently using the drug. However, in a letter to Novo Nordisk on February 5, the FDA stated that Novo Nordisk’s advertising for the drug constituted “misbranding,” and therefore its dissemination of the information violated federal law. In its letter, the FDA stated that Novo Nordisk’s advertising was misleading, suggesting that its oral medication was ...
- Source: drugdu
- 57
- February 12, 2026
Visipine®, the first and only oral S1P receptor modulator for ulcerative colitis in my country, has been approved, ushering in a new era of “deep healing”.

On February 6, 2026, the National Medical Products Administration (NMPA) of China officially approved Velisipity® (arginine eltromod tablets) for marketing, for the treatment of adult patients with moderate to severe active ulcerative colitis (UC) who have an inadequate response, loss of response, or intolerance to conventional therapies or biologics. This drug fills a significant gap in the treatment of moderate to severe ulcerative colitis and provides a new option for innovative oral treatments targeting deep mucosal healing. As a new generation of highly selective S1P receptor modulators, Visiprine® is taken orally once daily, enabling rapid onset of action and potent deep mucosal healing, while also possessing good safety profiles. It has the potential to be the best-in-disease and provides a new first-line treatment option for adult patients with ulcerative colitis. The incidence of UC is rising and showing a trend towards affecting younger people. Mucosal healing has a low clinical ...
- Source: drugdu
- 60
- February 12, 2026
Multi-dimensional Breakthroughs in Policy, Rules, and Pricing

As the final year of the 14th Five-Year Plan, 2025’s successful completion of its goals and tasks not only lays a solid foundation for a good start to the 15th Five-Year Plan period but also demonstrates the significant achievements the country has made in the coordinated development and governance of the three medical systems (medical services, pharmaceuticals, and healthcare). Focusing on the area of centralized drug procurement, the core strategy for 2025 is to lay out plans around several dimensions, including the standardization and improvement of centralized procurement policies and the listing and withdrawal mechanisms, and the comprehensive monitoring and governance of pharmaceutical prices and procurement credit. 01 Centralized Procurement Policy In March 2025, the “Draft Plan for Further Optimizing Centralized Drug Procurement Policies (for Public Comment)” circulated within the healthcare industry and caused a stir. In May 2025, a second draft of the same plan circulated again. A comparison ...
- Source: drugdu
- 56
- February 12, 2026
The first subject has been dosed in the Phase I clinical trial of Yuandong Bio’s EP-0210 monoclonal antibody injection.

On the evening of February 9, Yuandong Bio issued an announcement stating that its wholly-owned subsidiary, Chengdu Youluo Biotechnology Co., Ltd., is conducting a Phase I clinical trial of its independently developed Class 1 biological drug EP-0210 monoclonal antibody injection for the treatment of inflammatory bowel disease, and recently completed the dosing of the first subject. The announcement shows that EP-0210 monoclonal antibody injection is a humanized IgG1 monoclonal antibody drug that targets human tumor necrosis factor-like ligand 1A (TL1A). Its proposed indication is inflammatory bowel disease. Its mechanism of action is to bind to human TL1A efficiently and block the TL1A-mediated pro-inflammatory signaling pathway, thereby playing a role in the treatment of inflammatory bowel disease. Yuandong Bio stated that TL1A antibody drug development is one of the most promising emerging targets in the field of inflammatory bowel disease research, and currently there are no drugs targeting the same target ...
- Source: drugdu
- 71
- February 10, 2026
Clinical trial of recombinant herpes zoster ZFA01 adjuvant vaccine (CHO cells) approved

On February 9, Zhifei Biological Products Co., Ltd. announced that it had recently learned that the recombinant herpes zoster ZFA01 adjuvant vaccine (CHO cell) developed by its wholly-owned subsidiary Zhifei Longcom has received a drug clinical trial approval notice from the National Medical Products Administration, agreeing to conduct clinical trials for the prevention of herpes zoster in people aged 40 and above. If the project progresses smoothly, it will further enrich Zhifei Biological’s adult vaccine portfolio and improve its product portfolio. However, it should be noted that drug development is characterized by large investments, long cycles, and high risks, and there are uncertainties regarding the progress, results, and market launch of subsequent clinical trials. This vaccine uses a novel, independently developed adjuvant that can simultaneously stimulate both cellular and humoral immune responses, potentially enhancing its protective efficacy. However, the shingles vaccine market is highly competitive, and its commercial performance remains ...
- Source: drugdu
- 61
- February 10, 2026
Heyu Pharmaceuticals’ FGFR4 inhibitor ipagoglottinib has received Fast Track designation from the FDA for the treatment of advanced HCC patients with FGF19 overexpression who have been treated with ICIs and mTKIs.

On February 10, 2026, Shanghai Heyu Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as “Heyu Biopharmaceutical”, HKEX code: 02256) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Heyu Biopharmaceutical’s independently developed highly selective small molecule FGFR4 inhibitor, ipraginib (Irpagratinib/ABSK-011) , for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received immune checkpoint inhibitor (ICI) and multi-target kinase inhibitor (mTKI) therapy and have FGF19 overexpression. Currently, there is a lack of effective follow-up treatment options for patients with advanced or unresectable HCC after ICI and mTKI therapy. Studies show that approximately 30% of HCC patients overexpress FGF19, and these patients have a relatively poor prognosis after first-line targeted immunotherapy. Therefore, precise targeted therapy against the FGF19/FGFR4 signaling pathway holds promise for providing new and effective options for these patients. Ipatoloteinib is a highly selective FGFR4 inhibitor independently developed by Heyu ...
- Source: drugdu
- 62
- February 10, 2026
Sanofi’s “Rilzabrutinib” has been recognized as a Breakthrough Therapy in the United States and an Orphan Drug in Japan, and has applied for marketing approval in China.

Today, Sanofi announced that its investigational oral BTK inhibitor, Rilzabrutinib, has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug designation by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of warm autoimmune hemolytic anemia (wAIHA).According to Sanofi’s announcement, both recognitions are based on clinical data from the ongoing LUMINA Phase 2b study (Clinical Study No.: NCT05002777), which aims to evaluate the efficacy and safety of rizabutinib in patients with wAIHA. In addition, the newly initiated LUMINA Phase 3 study (Clinical Study No.: NCT07086976) is evaluating the efficacy of rizabutinib versus placebo in patients with wAIHA.In addition, the drug has been approved for marketing in the United States, the European Union and the United Arab Emirates (UAE) under the brand name Wayrilz for the treatment of immune thrombocytopenic purpura (ITP) in adults. (Image source: Sanofi official website) Follow NewDrugs.com ...
- Source: drugdu
- 57
- February 10, 2026
Domestically developed blockbuster ADC approved for new indication

On February 6, the NMPA website showed that Kelun Biotech’s TROP2 ADC, sasugamucil ( sac-TMT), has been approved for a new indication: the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) who have previously received endocrine therapy and other systemic therapies at an advanced or metastatic stage . This indication had previously been included in the priority review and approval process by the CDE (Center for Drug Evaluation). Screenshot source: NMPA official website Sacubituzumab is an ADC drug targeting TROP2 developed by Kelun Biotech. It is composed of a humanized monoclonal antibody, Sacituzumab, an enzymatically cleavable linker, and a novel topoisomerase I inhibitor, T030, with an average drug-to-antibody ratio (DAR) as high as 7.4. In May 2022, Kelun Biotech and Merck signed a collaboration agreement, granting the latter exclusive rights to develop, use, manufacture, ...
- Source: drugdu
- 62
- February 10, 2026
Novartis’s first-ever autoimmune drug has been submitted for marketing approval in China.

On February 6, the CDE website showed that Novartis’ ianalumab had applied for marketing approval in China. Ilimumab, acquired by Novartis (from MorphoSys) , is a fully human monoclonal antibody targeting B-lymphocyte activating factor receptor ( BAFF-R ). It possesses a dual mechanism of action: depleting B cells and inhibiting BAFF-R. It can be used to treat various autoimmune diseases, including Sjögren’s syndrome, immune thrombocytopenic purpura (ITP), and systemic lupus erythematosus (SLE) . This drug is the first anti- BAFF-R antibody to complete Phase III trials.In the phase III NEPTUNUS-1 study , after 48 weeks of illuminumab treatment, patients with Sjögren’s syndrome had a 6.4-point reduction in the EULAR Sjögren’s Disease Activity Index (ESSDAI) score, compared to a 5.1-point reduction in the placebo group. In the phase III NEPTUNUS-2 study, patients with Sjögren’s syndrome who received irinumab treatment for 48 weeks experienced a 6.5-point reduction in their ESSDAI score, compared ...
- Source: drugdu
- 49
- February 10, 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.