PharmaFocus Today – Page 10 – media

Sunshine Novo’s Small Nucleic Acid Drug IND Application Accepted; Innovative Drug Pipeline Enters Harvest Phase

SSE News / China Securities Online (Reporter: Li Yanzheng) — Sunshine Novo announced on January 21, 2026, that its investigational small nucleic acid drug, ABA001, has formally received Clinical Trial Application (IND) acceptance from the National Medical Products Administration (NMPA). The drug is targeting hypertension, marking a pivotal step forward for the company’s nucleic acid drug platform. ABA001 utilizes GalNAc covalent conjugation technology to precisely deliver siRNA into hepatocytes, specifically degrading AGT mRNA to effectively “shut off” the pressor switch of the Renin-Angiotensin-Aldosterone System (RAAS). Non-clinical data demonstrate that a single subcutaneous injection can produce rapid and sustained blood-pressure-lowering effects in animal models, accompanied by a favorable safety profile. Classified as a Category 1 innovative chemical drug, ABA001 is intended for the treatment of primary hypertension. It offers the potential for quarterly or even semi-annual dosing, a significant improvement over existing daily medications. According to the regulatory review process, if ...
- Source: drugdu
- 64
- January 22, 2026
Big news! Chia Tai Tianqing’s oral GLP-1 has been approved for clinical trials! Can its differentiated “biased” mechanism break through the red ocean market?

On January 20, the CDE (Center for Drug Evaluation) announced the implicit approval for clinical trials, showing that TQF3250 capsules, an oral weight-loss product submitted by Chia Tai Tianqing Pharmaceutical Group in November last year, has been approved for clinical trials. Unlike the more familiar GLP-1 receptor agonists on the market, TQF3250 is an “orally administered small molecule-biased GLP-1 receptor agonist.” It preferentially activates cAMP-related pathways, reducing β-arrestin recruitment and receptor endocytosis, aiming to achieve a better balance between duration of action and tolerability. From a mechanistic research perspective, the signal bias of the GLP-1 receptor is indeed considered a potential direction for optimization by the academic community. Rewinding to a month ago, a landmark event occurred in the global narrative of oral weight-loss drugs. Novo Nordisk’s oral weight-loss drug received FDA approval in December 2025, seizing a crucial position in the oral weight-loss drug market. Subsequently, Eli Lilly’s oral ...
- Source: drugdu
- 53
- January 22, 2026
Industry News | Roche’s Class 1 Oral GLP-1 Receptor Agonist Approved for Clinical Trials in China

On January 20, the website of the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) announced that Roche’s Class 1 new drug RO7795081 has been approved for clinical trials in China, intended for long-term weight management in overweight or obese patients. Public information shows that RO7795081 (CT-996) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist . Roche previously entered into a merger agreement with Carmot Therapeutics, acquiring the company for approximately $3.1 billion, thereby gaining access to three GLP-1 investigational therapies, one of which is CT-996. Publicly available information shows that, unlike endogenous GLP-1 hormones, CT-996 is specifically designed as a biased GLP-1 receptor agonist that activates cAMP signaling with minimal recruitment of β-arrestin. These precisely modulated signaling properties promise to lead to robust glycemic control, resulting in significant weight loss and good tolerability. In July 2024, Roche announced positive results from a Phase 1 clinical ...
- Source: drugdu
- 58
- January 22, 2026
Phase III Clinical Trial of Recombinant Staphylococcus Aureus Vaccine Progressing Normality

Securities Daily Online, Jan 20 (Reporter) — Olymvax Biopharmaceuticals stated during an investor survey that the Phase III clinical trial of the company’s recombinant Staphylococcus aureus vaccine is proceeding as planned. As of now, the study remains blinded, and no efficacy data has been generated yet. The company expects to complete the initial and confirmatory testing of all serum samples in the first quarter of this year (2026). Meanwhile, data cleaning is currently underway. It is anticipated that after completing data cleaning and obtaining the serum test reports in the first half of this year, the company will be able to perform a periodic database lock and the first unblinding for protective efficacy analysis. As vaccine clinical trials are susceptible to various factors, the final progress and results of the clinical trials shall be subject to the company’s official public disclosures. https://finance.eastmoney.com/a/202601203624958315.html
- Source: drugdu
- 64
- January 21, 2026
Its drug marketing application for injectable iza-bren has been accepted

On January 20, Baili Tianheng (688506.SH) announced that it had received an Acceptance Notice from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The NDA for its independently developed, first-in-class, new-concept EGFR×HER3 bispecific antibody ADC (iza-bren), the only one to enter Phase III clinical trials, has been formally accepted. Iza-bren, used to treat recurrent or metastatic esophageal squamous cell carcinoma, has also been included in the priority review list by the CDE. This drug is the world’s first EGFR×HER3 bispecific antibody ADC to have its NDA accepted. Iza-bren is currently undergoing more than 40 clinical trials in China and the United States targeting various tumor types. To date, iza-bren has 7 indications included in the CDE’s Breakthrough Therapy List, 2 indications included in the CDE’s Priority Review List, and 1 indication included in the U.S. Food and Drug Administration’s Breakthrough Therapy List. https://finance.eastmoney.com/a/202601203624810110.html
- Source: drugdu
- 69
- January 21, 2026
Kain Technology withdrew a drug registration application, resulting in a profit reduction of 111 million yuan in 2025

On January 20, 2026, KAIN Technology, a company listed on the Science and Technology Innovation Board,(688687.SH) disclosed that it has withdrawn its drug registration application for Peicheng Interferon α-2 Injection (with the addition of hepatitis B indication). Peicheng Interferon α-2 Injection is a marketed drug indicated for the treatment of chronic hepatitis C (HCV) in adults. It obtained drug registration approval and a new drug certificate in 2018. In September 2024, KAIYIN Technology submitted an application for a new indication for the drug. The application withdrawn this time pertains to this newly submitted indication. According to the latest review recommendations from the National Medical Products Administration ( NMPA) , and after careful consideration, the company has decided to voluntarily withdraw its drug registration application. It will further supplement its clinical case studies in accordance with the relevant requirements of the NMPA and resubmit the registration application as appropriate. Kaiyin Technology ...
- Source: drugdu
- 56
- January 21, 2026
Received Notice of Approval for Drug Clinical Trial

Hengrui Pharma announced on January 20, 2026, that the company and its subsidiaries, Suzhou Shengdia Biopharmaceutical Co., Ltd. and Shanghai Hengrui Pharmaceutical Co., Ltd., have received the “Notice of Approval for Drug Clinical Trial” issued by the National Medical Products Administration (NMPA) for SHR-9839 for Injection (sc) and HRS-4642 Injection. Clinical trials for these drugs will commence in the near future. Additionally, its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the “Notice of Approval for Drug Clinical Trial” from the NMPA for HRS-2141 Tablets (I) and (II), and will also begin clinical trials shortly. https://finance.eastmoney.com/a/202601203624765352.html
- Source: drugdu
- 68
- January 21, 2026
Breaking news! AstraZeneca to be delisted from Nasdaq.

On January 20 , Reuters reported that AstraZeneca announced a major restructuring of its listing : the company will delist its American Depositary Receipts ( ADS ) and debt securities from Nasdaq and directly list its common stock and debt products on the New York Stock Exchange. The changes will take effect after the close of trading on January 30 , 2026 . It is understood that AstraZeneca ‘s common stock and debt securities are expected to begin trading on the NYSE on February 2 , and will continue to use the stock code “AZN” to ensure trading continuity for investors. This restructuring of the listing structure is a core component of the unified listing plan approved by AstraZeneca shareholders. Following the implementation of the unified structure, AstraZeneca will shift from trading ADSs (representing its common stock at a 2-to-1 ratio) to directly listing its $0.25 common stock, thereby simplifying ...
- Source: drugdu
- 69
- January 21, 2026
XinYue Bio Secures Tens of Millions in Series A+ Follow-on Funding to Advance DEL+AI-Powered Drug Discovery

Xinyue Bio closes multi-million RMB Series A+ round with follow-on from XtalPi (2228.HK). This latest funding, secured within six months of XtalPi’s initial investment, underscores strong investor confidence. The funds will drive the R&D of Xinyue Bio’s “DEL+AI” platform and accelerate the clinical development of its pipeline, aiming to boost efficiency and success rates in early drug discovery. Synergy in Action: Building a New Engine for Drug R&D Xinyue Bio specializes in the advanced development and application of DNA-Encoded Library (DEL) technology, dedicated to empowering and advancing innovative drug discovery. The company’s proprietary DEL live-cell screening platform enables effective screening of membrane proteins that are difficult to express and purify. This not only expands the range of druggable targets accessible to DEL technology but also represents a screening approach that more closely mimics physiological conditions. As a pioneer in AI-driven drug discovery, XtalPi leverages a high-precision drug design platform that ...
- Source: drugdu
- 50
- January 21, 2026
20-Valent Pneumococcal Vaccine Approved for Clinical Trials

On January 19, AIM Vaccine (06660.HK) issued an announcement stating that its self-developed 20-valent pneumococcal polysaccharide conjugate vaccine (PCV20) has received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA), officially granting approval for clinical trials. The vaccine is an optimized upgrade of the 13-valent pneumococcal conjugate vaccine (PCV13), adding 7 new serotypes for a total of 20 major prevalent serotypes. It is designed to prevent invasive diseases caused by these serotypes, such as pneumonia, meningitis, and bacteremia. https://finance.eastmoney.com/a/202601193623487020.html
- Source: drugdu
- 67
- January 20, 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.