PharmaFocus Today – Page 6 – media

Kanghong Pharmaceutical’s Class 1 new drug receives clinical trial approval

On February 25, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its website that KHN707 tablets, a Class 1 new chemical drug submitted by Chengdu Kanghong Pharmaceutical Group Co., Ltd., has been approved for clinical trials . This is an oral small-molecule selective orexin receptor (OX2R) antagonist independently developed by Kanghong Pharmaceutical . The approved indication for clinical trials is insomnia , and it has shown sleep-promoting effects in various insomnia efficacy models in preclinical studies. Insomnia patients mainly experience difficulty falling asleep, sleep maintenance disorders, and reduced total sleep time. Persistent insomnia can cause symptoms such as low mood, poor memory, and difficulty concentrating, not only affecting daily life and work but also leading to other central nervous system disorders, such as varying degrees of depression. According to data from the “Guidelines for the Diagnosis and Treatment of Insomnia in Chinese Adults ...
- Source: drugdu
- 75
- February 26, 2026
Bio-Thera Solutions’ innovative drug, Darpubayimab injection, has had its marketing authorization application accepted by the NMPA

Bio-Thera Solutions, Ltd. (SSE: 688177 ) is a global, science-driven biopharmaceutical company located in Guangzhou, China, hereinafter referred to as ” Bio-Thera ” or ” the Company ” . The Company’s marketing authorization application for its product, darpubayimab injection (hereinafter referred to as “BAT4406F” ), for the treatment of neuromyelitis optica spectrum disorder (NMOS D ) positive for anti-aquaporin 4 (AQP4) antibodies, has recently been accepted by the National Medical Products Administration. In July 2025, the interim analysis of the pivotal Phase II/III registration clinical trial of BAT4406F in neuromyelitis optica spectrum disorders (NMOSD) showed significant benefit in the experimental group, leading to a recommendation from the Independent Data Monitoring Committee (IDMC) to “terminate the trial early,” thus ending participant recruitment early. The BLA application was completed in early February 2026. NMOSD is a rare autoimmune disease characterized by high relapse and high disability rates. Its core clinical manifestations include ...
- Source: drugdu
- 65
- February 25, 2026
Dashi Pharmaceuticals licenses its migraine medication to NewCo in the United States.

On February 25th, Dashi Pharmaceutical announced an exclusive licensing agreement with Slate Medicines, a rising US biopharmaceutical company operating under the NewCo model. Dashi Pharmaceutical will exclusively license the global clinical development and commercialization rights outside of Greater China to Slate Medicines for its independently developed monoclonal antibody DS009 (SLTE-1009), which targets pituitary adenylate cyclase-activating peptide (PACAP). This drug will be used for the prevention and treatment of headaches such as migraines, and will also become the first domestically developed non-opioid biological analgesic to be exported. Slate Medicines has simultaneously completed a $130 million Series A funding round, co-led by leading US healthcare investment firms including RA Capital Management, Forbion, and Foresite Capital. The funds will primarily be used to advance the global clinical development of DS009. The company is led by CEO Gregory Oakes, who has over 30 years of industry experience. Mr. Oakes also recently served as a ...
- Source: drugdu
- 64
- February 25, 2026
United Laboratories subsidiary, UBT251 injection (a Class 1 innovative drug), achieved near-20% weight loss in Phase II clinical trials

On February 24, United Laboratories (03933) issued an announcement stating that its wholly-owned subsidiary, United Biotechnology (Zhuhai Hengqin) Co., Ltd., has independently developed a Class 1 innovative drug. UBT251 injection has completed a Phase II clinical trial in overweight/obese patients in China. This study included 205 obese or overweight patients with weight-related comorbidities. The participants had a baseline mean weight of 92.2 kg and a baseline mean BMI of 33.1 kg. The results showed that after 24 weeks of administration, the mean weight change from baseline was the highest in each of the UBT251 dose groups, reaching -19.7% (-17.5 kg), while the placebo group showed -2.0% (-1.6 kg). Furthermore, UBT251 significantly improved key secondary endpoints such as waist circumference, blood glucose, blood pressure, and blood lipids compared to placebo, with good overall safety and tolerability, and no withdrawals due to adverse events occurred. The company will initiate a Phase III clinical ...
- Source: drugdu
- 46
- February 25, 2026
Dongyangguang Pharmaceutical’s first anti-Nipah virus “lifesaving drug” has entered clinical trials, achieving a 100% mortality protection rate in animal prevention.

On February 24, Dongyangguang Pharmaceutical (06887) issued an announcement stating that the Center for Drug Evaluation of the National Medical Products Administration of China has formally accepted the company’s application for clinical trials of HEC-648 injection, a monoclonal antibody new drug targeting the Nipah virus G protein. Phase I clinical research is expected to be officially launched in 2026. Nipah virus is a highly lethal single-stranded negative-sense RNA virus, with a mortality rate ranging from 40% to 75%. Currently, Nipah virus is classified as a biosafety level 4 virus, and there are no approved targeted treatments or vaccines available.。 HEC-648 injection is a fully human monoclonal antibody targeting the Nipah virus G protein, a research achievement of the Wuhan Institute of Virology, Chinese Academy of Sciences. In animal model experiments, this drug demonstrated a 100% preventative mortality protection rate and over 80% therapeutic mortality protection rate, making it the first ...
- Source: drugdu
- 43
- February 25, 2026
34 million patients no longer rely on imported drugs

In China, the number of people suffering from attention deficit hyperactivity disorder (ADHD) has exceeded 34 million. For a long time, the clinical treatment of this group has been heavily reliant on imported drugs. With the launch of the first generic drug by Lifang Pharmaceutical, the approval of multiple dosage forms of improved new drugs by Youer Pharmaceutical, and the successful approval of innovative compound preparations by Aikebaifa, several domestically produced ADHD treatment drugs have been launched, and the reliance on imported drugs is gradually being broken. In the ADHD sector, a breakthrough battle for domestic substitution and upgrading has officially begun. 01 Market potential awaits release Attention deficit hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder characterized by disproportionate attention deficits and hyperactivity, manifesting as poor concentration, impulsivity, hyperactivity, and learning difficulties. According to the “Pediatric Expert Consensus on Early Identification, Standardized Diagnosis and Treatment of Attention Deficit ...
- Source: drugdu
- 47
- February 25, 2026
How far can GLP-1 go in the weight loss race?

At the start of 2026, a business development (BD) deal between CSPC Pharmaceutical Group and AstraZeneca set a new record for the highest amount of foreign licensing for Chinese biopharmaceutical companies, with a potential value of over US$18.5 billion. This record-breaking business development deal has once again propelled the research and development of weight-loss drugs to a new level . According to the agreement, AstraZeneca has acquired the global exclusive rights to CSPC Pharmaceutical Group’s once-monthly injectable weight management product portfolio outside of Greater China, including one clinical-ready project SYH2082, three preclinical projects, and four new collaborative projects based on CSPC Pharmaceutical Group’s platform. It is worth mentioning that SYH2082 is a GLP1R/GIPR agonist, which means that GLP-1 will continue to be popular in the weight loss field. 01 Blood sugar reduction has been unknown for many years One day of weight loss produced a medicine king With the release ...
- Source: drugdu
- 45
- February 25, 2026
Aohong Pharmaceutical | Drug registration application for Motomidyl Hydrochloride Injection accepted by CDE

Recently, the National Medical Products Administration accepted the drug registration application of Motomidate Hydrochloride Injection (Project Code: ET-26, Application Registration Category: Class 1 Chemical Drug; hereinafter referred to as “the new drug”) by Jinzhou Aohong Pharmaceutical Co., Ltd., a subsidiary of Fosun Pharma (stock code: 600196.SH; 02196.HK). The proposed indication for this application is for anesthesia induction and short-term surgical anesthesia. This new drug is a Class 1 new drug for intravenous general anesthesia and was included in the “Major New Drug Development” science and technology major project in 2014.According to the latest data from IQVIA CHPA1 , in 2024, sales of similar drugs (such as etomidate) used for anesthesia induction and short-term surgical anesthesia in mainland China (excluding Hong Kong, Macao and Taiwan) amounted to approximately RMB 4.238 billion.As a wholly-owned subsidiary of Fosun Pharma, Aohong Pharmaceutical has always regarded innovation as the core driving force for its sustainable ...
- Source: drugdu
- 48
- February 24, 2026
Hansoh Pharmaceutical’s blockbuster new drug has been approved for marketing in the European Union!

Just now, Hansoh Pharmaceutical announced that its innovative drug, Ametinib Mesylate Tablets (Chinese trade name: Ameile® , overseas trade name: Aumseqa® ) , has been officially approved by the European Commission ( EC ) for marketing in the European Union for the treatment of: First-line treatment for adult patients with advanced non-small cell lung cancer ( NSCLC ) with epidermal growth factor receptor ( EGFR ) exon 19 deletion or exon 21 ( L858R ) substitution mutation ; Treatment of adult patients with advanced EGFR T790M mutation-positive NSCLC . This approval came after the European Medicines Agency ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) issued a positive opinion. Ametinib thus becomes the first Chinese-developed EGFR-TKI drug to receive EU approval, marking another breakthrough for domestically produced targeted innovative lung cancer drugs in the European market. Ametinib mesylate tablets (Aumseqa® ) are China’s first original ...
- Source: drugdu
- 55
- February 24, 2026
Jinsai Pharmaceutical’s new drug officially approved for clinical trials to improve micropenis in children!

On February 24, the CDE website showed that GenSci141 ointment , submitted by Jinsai Pharmaceutical , was approved for clinical trials. It is indicated for improving micropenis in children caused by hypergonadotropic hypogonadism, 5α-reductase 2 deficiency, congenital adrenal hyperplasia with reduced androgen synthesis, and idiopathic causes. The registration categories are 2.2 and 2.4. GenSci141 ointment is a dihydrotestosterone ointment developed by Jinsai Pharmaceutical . It mainly works by paracrine secretion within target tissues, targeting and promoting penile tissue growth and development. According to publicly available information, there are currently no approved drugs worldwide specifically for micropenis in children, indicating a significant unmet clinical need. If successful, GenSci141 ointment could become the world’s first drug specifically for micropenis in children. https://mp.weixin.qq.com/s/lKYLBl1EyMWSjlHehOE0Kw
- Source: drugdu
- 52
- February 24, 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.