The approval is for pediatric patients living with either moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. This approval expands indications of use beyond the initial adult population and is the first and only pediatric approval for an interleukin-23 inhibitor. The approval is based on results from the phase 3 PROTOSTAR study in which the coprimary end points of Psoriasis Area Severity Index (PASI) 90 and Investigator’s Global Assessment (IGA) score of 0/1 were achieved at week 16. More than half of patients (56 percent) receiving Tremfya achieved PASI 90 versus 16 percent of patients receiving placebo. For IGA score, at week 16, two-thirds (66 percent) of patients receiving Tremfya achieved high levels of skin clearance (score 0/1) versus 16 percent of patients receiving placebo. Complete clearance (IGA 0) at week 16 was achieved by nearly 40 percent of pediatric patients receiving Tremfya ...
Drugdu.com expert’s response: The “generic drug consistency evaluation” marked on Moxifloxacin Hydrochloride Tablets indicates that this generic drug has undergone comparative quality and efficacy trials with the original branded drug and has been proven to possess equivalent quality and efficacy. Specific Meaning and Background Definition and Purpose: The generic drug consistency evaluation is a systematic assessment conducted on already-marketed generic drugs. It requires that generic drugs maintain consistency with the original branded drug in terms of active ingredients, dosage forms, specifications, routes of administration, and therapeutic effects. The core objective is to ensure that generic drugs can serve as substitutes for the original branded drugs, delivering the same therapeutic effects while guaranteeing public safety and efficacy in medication use. Policy Background: China initiated the generic drug consistency evaluation program in 2016, aiming to enhance the overall quality of generic drugs through a phased approach to quality consistency evaluation. Drugs that ...
Even though many years have passed since the start of the COVID-19 pandemic, the effects of infection with SARS-CoV-2 are not completely understood. This is especially true for Long COVID, a chronic condition that can develop after COVID-19 that causes a variety of lasting symptoms. Among the most common and debilitating of these is cognitive impairment, often referred to as “brain fog,” which affects over 80% of people with Long COVID. Given the hundreds of millions of global cases, Long COVID represents a massive public health and socioeconomic challenge, as it severely impacts people’s ability to work and perform daily activities. Unfortunately, despite its prevalence, the underlying causes of Long COVID and brain fog remain poorly understood. Previous imaging studies have shown some structural changes in the brain, but they could not pinpoint the molecular dysfunctions responsible for the cognitive symptoms. Since it’s difficult to observe the molecules that govern ...
Depending on which vaccine they received, HPV infections fell by 76% to 98% over 17 years among vaccinated women, researchers reported in the journal JAMA Pediatrics. But infections also fell by 72% to 76% among unvaccinated women during the same period, results showed. “There are two encouraging takeaways from our study,” said senior researcher Dr. Jessica Kahn, chair of head and neck pathology at the Albert Einstein College of Medicine in New York City. “First, HPV vaccines work remarkably well in a real-world setting, even among women at high risk for HPV and who may not have received all vaccine doses,” she said in a news release. “Second, we saw clear evidence of herd immunity, meaning when enough people are vaccinated, the vaccine indirectly protects unvaccinated people by reducing overall virus transmission.” Kahn said these results “reinforce the potential of the HPV vaccine to prevent infection and, ultimately, eliminate cervical cancer globally.” Long-lasting ...
an investor asked on the investor interaction platform: When is the company’s nine-valent vaccine expected to be launched? What is its current stage? What is the annual production capacity of the company’s production line? Watson Bio(300142.SZ) stated on the investor interaction platform on September 24 that the company’s related work on the Phase III clinical study of the nine-valent HPV vaccine is ongoing. If there is any substantial and phased progress in the research and development of the company’s vaccine, the company will disclose it in a timely manner. Please pay attention to the relevant information disclosed by the company for subsequent progress. Source;https://finance.eastmoney.com/a/202509243522306220.html
SecuritiesDaily News Zhifei BiologyWhen answering investors’ questions on the interactive platform on September 26, it was stated that the company had achieved controlling stake in Chenan Bio through capital increase this year, and the company’s business had extended from vaccines to metabolic diseases. Source:https://finance.eastmoney.com/a/202509263524977168.html
Taienkang announced that its controlling subsidiary, Broad Venture Park, has received a “Notice of Approval for Drug Clinical Trial” from the National Medical Products Administration (NMPA), authorizing the conduct of a Phase II/III seamless adaptive clinical trial of CKBA Cream for the rosacea indication. CKBA Cream is a topical preparation independently developed by Broad Venture Park and is a Category 1 innovative chemical drug. To date, no Category 1 innovative drug for the treatment of rosacea has been approved for marketing in China . Tainkang’s innovative drug has been approved for clinical trials and is expected to fill the treatment gap for rosacea indications in China . If clinical trials can prove its efficacy, the market potential is considerable. Source:https://www.stcn.com/article/detail/3358450.html
Baili Tianheng issued an announcement stating that the company’s independently developed iza-bren (EGFR×HER3 dual-antibody ADC), the world’s first, new concept and the only one to enter the Phase III clinical stage, is used for patients with unresectable locally advanced or metastatic urothelial carcinoma who have failed previous treatment with platinum-containing chemotherapy and PD-1/PD-L1 inhibitors. It has been included in the list of breakthrough therapies by the Drug Review Center of the National Medical Products Administration. To date, seven indications of Iza-bren have been included in the list of breakthrough therapies by the Center for Drug Evaluation, and one indication has been granted breakthrough therapy designation by the U.S. Food and Drug Administration. The National Medical Products Administration’s Center for Drug Evaluation prioritizes resources for drugs included in the Breakthrough Therapy designation, strengthening guidance and promoting drug development. Baili Tianheng’s Iza-bren has been designated a Breakthrough Therapy, which is expected to ...
On the evening of September 29th, Luoxin Pharmaceutical (002793) announced that it plans to raise no more than 842 million yuan for innovative drug research and development projects, raw material drug expansion and freeze-drying workshop technology renovation projects, and to supplement working capital. According to the data, Luoxin Pharmaceutical is mainly engaged in the research, development, production and sales of pharmaceutical products, focusing on digestion, respiration, anti-tumor and other advantageous fields. Its products are mainly chemical preparations, chemical raw materials, and traditional Chinese patent medicines and simple preparations. The company was listed on the Shenzhen Stock Exchange in April 2016. Luoxin Pharmaceutical stated that in order to strengthen the company’s innovative drug product layout and improve the market competitiveness of innovative drug products, the innovative drug research and development project in this fundraising investment project will focus on the Phase II and III clinical studies of LX22001 for injection to ...
Changchun High tech, which once dominated the capital market with growth hormone, is accelerating its plan to go public in Hong Kong after experiencing a performance slump, attempting to find a new way out in the midst of difficulties. On September 29th, according to the Hong Kong Stock Exchange, Changchun High Tech Industry (Group) Co., Ltd. (referred to as “Changchun High Tech”) from Changchun, Jilin submitted a prospectus to the Hong Kong Stock Exchange, intending to be listed on the main board of Hong Kong. Changchun High Tech was listed on the Shenzhen Stock Exchange on December 18, 1996, and as of the close of trading on September 29, 2025, its total market value was RMB 52.583 billion. This marks the official launch of the “A+H” dual platform listing journey for the growth hormone Mao, which once created a “myth” in the A-share market. A pharmaceutical industry analyst from a ...
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