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]

Core Insights - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the marketing of Tebrostone tablets in China [1] Group 1: Product Information - Tebrostone tablets are a selective estrogen receptor modulator developed by Jinsai Pharmaceutical, classified as a Class 4 oral chemical drug, aimed at treating low estrogen symptoms in women due to natural or surgical menopause [1] - Tebrostone is a synthetic steroid hormone with weak hormonal activity, relying on local enzyme activity and specific metabolic mechanisms in different tissues to exert various effects [1] - Upon oral administration, Tebrostone is rapidly metabolized into three compounds that mediate its pharmacological effects, with two metabolites exhibiting estrogen-like activity and a third metabolite showing progestogenic and androgenic activity [1] Group 2: Market and Clinical Relevance - The Tebrostone tablets developed by Jinsai Pharmaceutical are a generic drug targeting unmet market and clinical needs [2] - Clinical trial results from a bioequivalence study indicate that Jinsai's Tebrostone tablets are bioequivalent to the original drug and demonstrate good safety, providing more treatment options for menopausal women experiencing low estrogen symptoms [2]

格隆汇9月29日丨长春高新(000661.SZ)公布，公司已于2025年9月29日向香港联合交易所有限公司（简 称"香港联交所"）递交了发行境外上市外资股（H股）股票并在香港联交所主板上市的申请，并于同日 在香港联交所网站刊登了本次发行上市的申请资料。本次发行上市事项的相关申请资料为公司按照香港 证券及期货事务监察委员会及香港联交所的要求编制和刊发，为草拟版本，其所载资料可能会适时作出 更新及修订，投资者不应根据其中的资料作出任何投资决定。 ...

Core Insights - Changchun High-tech (000661.SZ) announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd. (referred to as "Jinsai Pharmaceutical"), has received approval from the National Medical Products Administration for the marketing of its drug, Tebrostone Tablets [1] Group 1: Product Information - Tebrostone Tablets are a selective estrogen receptor modulator developed by Jinsai Pharmaceutical, classified as a Class 4 oral chemical drug, aimed at treating low estrogen symptoms in women due to natural or surgical menopause [1] - Tebrostone is a synthetic steroid hormone with weak hormonal activity, relying on local enzyme activity and specific metabolic mechanisms in different tissues to exert various effects [1] - Upon oral administration, Tebrostone is rapidly metabolized into three compounds that mediate its pharmacological effects, with two metabolites exhibiting estrogen-like activity and a third metabolite showing progestogenic and androgenic activity [1] Group 2: Market and Clinical Relevance - The Tebrostone Tablets developed by Jinsai Pharmaceutical are a generic drug targeting unmet market and clinical needs [2] - A completed bioequivalence study demonstrated that Jinsai Pharmaceutical's Tebrostone Tablets are bioequivalent to the original drug and have good safety profiles, providing more treatment options for menopausal women experiencing low estrogen symptoms [2]

Core Viewpoint - Changchun High-tech (000661.SZ) has submitted an application for the issuance of overseas listed foreign shares (H-shares) and for listing on the main board of the Hong Kong Stock Exchange on September 29, 2025 [1] Group 1 - The application materials for this issuance and listing have been prepared and published in accordance with the requirements of the Hong Kong Securities and Futures Commission and the Hong Kong Stock Exchange [1] - The published application materials are in draft form and may be updated and revised as necessary [1] - Investors are advised not to make any investment decisions based solely on the information contained in these materials [1]

Core Viewpoint - Changchun High-tech announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing of its drug, Teibolong Tablets, in China [1] Group 1: Company Information - Changchun Jinsai Pharmaceutical has developed Teibolong Tablets, which are classified as a selective estrogen receptor modulator [1] - The drug is categorized as a Class 4 oral chemical medication [1] - Teibolong Tablets are intended for the treatment of low estrogen symptoms caused by natural or surgical menopause in women [1]

Core Insights - Changchun High-tech is a leading innovation-driven pharmaceutical group in China, with a diverse product matrix covering therapeutic biopharmaceuticals, chemical drugs, vaccines, and traditional Chinese medicine [2] - The company has established a strong and diversified product portfolio in endocrine and metabolic diseases, women's health, immune and respiratory diseases, oncology, vaccines, and traditional Chinese medicine [2] - As of September 23, 2025, Changchun High-tech has over 40 candidates in clinical stages or with IND applications submitted, including 14 in Phase III clinical trials or NDA stages [2] Financial Performance - Revenue for the years 2022, 2023, 2024, and the six months ending June 30, 2025, were approximately RMB 12.63 billion, RMB 14.57 billion, RMB 13.47 billion, and RMB 6.64 billion respectively [4] - The company reported a profit of RMB 4.22 billion in 2022, RMB 4.78 billion in 2023, and RMB 2.71 billion in 2024, with a profit of RMB 1.80 billion for the six months ending June 30, 2025 [4] - Gross profit for the same periods was RMB 11.11 billion, RMB 12.52 billion, RMB 11.54 billion, and RMB 5.62 billion respectively [4]

Core Viewpoint - Changchun High-tech has submitted a listing application to the Hong Kong Stock Exchange, aiming to expand its market presence after being listed on the Shenzhen Stock Exchange. The company is recognized as a leading innovation-driven pharmaceutical group in China, with a comprehensive product portfolio across various drug categories [1]. Group 1: Company Overview - Changchun High-tech is a prominent pharmaceutical group in China, focusing on therapeutic biological agents, chemical drugs, vaccines, and traditional Chinese medicine, with capabilities in R&D, production, and commercialization across all major drug registration types [1]. - The company has established a competitive and diversified product matrix driven by a differentiated innovation strategy, leading to strong financial performance and sustainable growth [1]. Group 2: Product Development and Pipeline - As of September 23, 2025, Changchun High-tech has successfully launched 13 new drug products, including the first domestically developed shingles vaccine approved in January 2023 and the first innovative biological drug for acute gouty arthritis approved in June 2025 [2]. - The company is actively expanding the indications of its approved products to cover a broader patient population, such as the approval of Jin Sai Zeng for ISS and Turner syndrome in 2024, which addresses approximately 82.3% of the pediatric short stature population in China [2]. Group 3: Financial Performance - The company reported revenues of approximately RMB 126.27 billion, RMB 145.66 billion, RMB 134.66 billion, and RMB 66.03 billion for the fiscal years 2022, 2023, 2024, and the six months ending June 30, 2025, respectively. Corresponding profits for these periods were approximately RMB 42.15 billion, RMB 47.76 billion, RMB 27.08 billion, and RMB 9.32 billion [3].

据港交所文件，长春高新技术产业（集团）股份有限公司向港交所提交上市申请书，独家保荐人为中信 建投国际。 (本文来自第一财经) ...

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Construction Investment International as the sole sponsor, indicating its intention to expand its market presence after being listed on the Shenzhen Stock Exchange [1][3]. Group 1: Company Overview - Changchun High-tech is a leading innovation-driven pharmaceutical group in China, covering therapeutic biological agents, chemical drugs, vaccines, and traditional Chinese medicine, with comprehensive capabilities in R&D, production, and commercialization across all major drug registration types [3][4]. - The company has established a strong and diversified product portfolio in various therapeutic areas, including endocrine and metabolic diseases, women's health, immune and respiratory diseases, tumors, vaccines, and traditional Chinese medicine [4]. Group 2: Financial Performance - The sales revenue of Changchun High-tech's pharmaceutical products reached RMB 12.7 billion in 2024, maintaining over RMB 10 billion for four consecutive years [3]. - The company has consistently ranked among the "Top 100 Pharmaceutical Enterprises in China" for eight consecutive years since 2017 [3]. - Revenue figures for the fiscal years 2022 to 2025 show a growth trajectory, with revenues of approximately RMB 126.27 billion, RMB 145.66 billion, RMB 134.66 billion, and RMB 66.03 billion for the first half of 2025 [5][7]. Group 3: Product Development and Pipeline - As of September 23, 2025, Changchun High-tech has over 40 candidate drugs in clinical stages or submitted for IND applications, including 14 in Phase III clinical trials or NDA stages and 15 first-class innovative drugs [5]. - The company has successfully launched 13 new drug products during the historical record period, including the first domestically developed shingles vaccine approved in January 2023 and the first innovative biological drug for acute gouty arthritis approved in June 2025 [4][5].