Core Points - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received the drug registration certificate from the National Medical Products Administration for its application of αN02 injection of follicle-stimulating hormone, which has been approved for marketing in China [1] Company Summary - The approval of the αN02 injection marks a significant milestone for Changchun Jinsai Pharmaceutical, enhancing its product portfolio in the pharmaceutical market [1] - This development indicates the company's commitment to expanding its presence in the biopharmaceutical sector [1] Industry Summary - The approval of new drugs like αN02 injection reflects the ongoing growth and regulatory advancements within the pharmaceutical industry in China [1] - The successful registration of this drug may lead to increased competition and innovation in the reproductive health segment of the pharmaceutical market [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing of its drug, FSH-CTP injection, in China [1] Group 1: Company Information - The approved product is a long-acting recombinant human follicle-stimulating hormone (FSH-CTP) injection, developed using genetic engineering technology [1] - FSH-CTP is designed to replace the traditional 7-day regimen of follicle-stimulating hormone injections with a single subcutaneous injection [1] - The product falls under the category of therapeutic biological products, classified as type 3.2 [1] Group 2: Industry Context - The approval of FSH-CTP injection represents a significant advancement in reproductive health treatments, potentially improving patient compliance and treatment outcomes [1] - The use of CHO cell expression technology for drug development highlights the ongoing innovation within the biopharmaceutical industry in China [1]

Group 1 - The core point of the article is that Changchun High-tech (000661) announced the approval of two drugs by the National Medical Products Administration for market launch in China [1] Group 2 - Changchun High-tech's subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received the drug registration certificate for Tebentafusp tablets, which has been approved for sale in the domestic market [1] - The company also announced that its subsidiary received the drug registration certificate for Follitropin αN02 injection, which has also been approved for sale in the domestic market [1]

Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing of its drug, FSH-CTP injection, in China [1] Group 1: Company Overview - The approved product is a long-acting recombinant human follicle-stimulating hormone (FSH-CTP) injection, developed by Jinsai Pharmaceutical [1] - FSH-CTP is produced using genetic engineering technology, combining the human FSH gene with the carboxy-terminal peptide of the beta subunit of human chorionic gonadotropin (hCG) gene, expressed in Chinese hamster ovary (CHO) cells [1] Group 2: Product Details - The FSH-CTP injection is designed to replace the traditional 7-day regimen of FSH injections with a single subcutaneous injection [1] - It is classified as a Class 3.2 therapeutic biological product [1]