Shanghai RAAS Subsidiary's Protein C Clinical Trial Application Accepted

Product / Tech
โดย CLS·CN·Read original
Summary · why it matters

Shanghai RAAS announced that its wholly-owned subsidiary Guangxi RAAS Biopharmaceutical Co., Ltd. has received an acceptance notice from the National Medical Products Administration regarding the clinical trial application for Protein C. The drug is intended for the treatment of patients with congenital Protein C deficiency. It is a Class II new drug in China, and currently no similar human Protein C preparation has been approved for marketing domestically. If successfully approved for marketing, it could enhance the company's comprehensive utilization rate of plasma and optimize its product portfolio.

Impact on stocks 1

Others · 1 stocks

Theme Impact 1

Off-coverage companies 1

广西莱士生物制药有限公司Private▲ Positive
Technologyrelevance

As the subsidiary developing Protein C, the acceptance of its clinical trial application is a positive development.

Related news

3

Novo Nordisk's Frehemgo wins EMA panel backing for hemophilia A

A European Medicines Agency panel has recommended approval of Frehemgo, Novo Nordisk's injectable treatment for hemophilia A, moving the Danish drugmaker closer to another commercial opportunity outside its diabetes and obesity franchise. The recommendation covers adults and children, including patients with or without inhibitors, and follows results from Novo's FRONTIER clinical program, in which Frehemgo reduced annualized bleeding rates compared with previous clotting-factor preventive treatments and therapies given when bleeding occurred. Novo plans to sell Frehemgo in a single-use, prefilled pen with dosing options ranging from once weekly to once monthly, offering patients more flexibility. The European Commission still needs to give final approval, but Novo is already preparing for commercialization and expects to introduce Frehemgo in a selected European market during the fourth quarter, followed by a broader European Union rollout early next year. The next catalyst is European Commission approval and whether Novo can begin that first launch before year-end.
GuruFocus·1dRead more →

Kamada Says KedRAB Supply Adequate as U.S. Rabies Cases Rise

Kamada said it maintains an adequate supply of KedRAB, its human immune globulin targeting rabies, even as cases linked to the viral disease rise in the United States. The Israeli biotech's shares traded higher on Thursday following the statement. Last week the CDC issued a health advisory reporting a significant increase in human rabies exposures and the use of rabies post-exposure prophylaxis, with a 17% increase in rabies-related inquiries from July through August and a 76% rise in the utilization of two U.S.-licensed rabies immunoglobulins for the week ending Sept. 2. Kamada said that in light of the increase in end-user utilization described in the CDC advisory, it has the inventory and manufacturing capacity to support continued supply of KedRAB. With its Q2 2026 results in August, Kamada reiterated its full-year guidance for revenue and adjusted EBITDA at $200M–$205M and $50M–$53M, implying 12% and 23% year-over-year growth respectively.
Seeking Alpha·1dRead more →

Weiguang Biological's Belarus Blood Transfusion Center Cooperation Project Officially Delivered, Completing China's First Export of Blood Product Technology

Weiguang Biological has received the third-stage acceptance report issued by the Belarusian state institution, the Republican Scientific and Practical Center for Transfusiology and Medical Biotechnologies, marking the successful completion and delivery of the Weiguang Biological–Belarus Blood Transfusion Center blood product cooperation project. The company has thus become the first Chinese enterprise to complete the export of blood product technology. The project officially began in December 2022 and was implemented in three major stages, with all tasks in each stage passing acceptance on the first attempt. In December 2023, Weiguang Biological completed the verification and delivery of technical documents. In October 2024, Belarusian technical personnel came to China for full-time training and all successfully completed the program. Afterward, Weiguang Biological traveled to the Gantsevichi base to conduct production condition inspections and on-site process guidance, successfully completing the trial production of human albumin and intravenous human immunoglobulin as stipulated in the contract. Through cross-testing by both parties, all indicators of the semi-finished and finished products met the standards of the Pharmacopoeia of the People's Republic of China and the relevant Belarusian quality standards. The Belarusian Blood Transfusion Center highly praised Weiguang Biological's professional technical capabilities.
证券时报·2dRead more →