证券代码：000661 证券简称：长春高新 公告编号：2025-130 产品名称：绒促卵泡激素αN02 注射液 申请事项：上市申请 长春高新技术产业（集团）股份有限公司 关于子公司绒促卵泡激素αN02 注射液在境内获批上市的公告 受理号：CXSS2400073 和 CXSS2400074 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有 虚假记载、误导性陈述或重大遗漏。 近日，长春高新技术产业（集团）股份有限公司（以下简称"公司"）子公 司长春金赛药业有限责任公司（以下简称"金赛药业"）收到国家药品监督管理 局核准签发的《药品注册证书》，其申报的绒促卵泡激素αN02 注射液已在境内 获批上市，现将相关情况公告如下： 一、药品的基本情况 申请人：长春金赛药业有限责任公司 绒促卵泡激素αN02注射液是金赛药业针对上述未满足的临床需求研发的一 款长效FSH制剂，目前已完成Ⅰ、Ⅱ和Ⅲ期完整开发流程。根据已完成的绒促卵 泡激素αN02注射液在接受辅助生殖技术治疗进行COS以促进多个卵泡发育的受 试者中进行的Ⅱ期和Ⅲ期临床试验结果显示，该制剂在有效性和安全性方面均表 现优异。公司绒促卵泡激素αN02注射液在 ...

证券代码：000661 证券简称：长春高新 公告编号：2025-129 长春高新技术产业（集团）股份有限公司 关于向香港联交所递交境外上市外资股（H股） 发行上市申请并刊发申请资料的公告 长春高新技术产业（集团）股份有限公司（以下简称"公司"）已于2025 年9月29日向香港联合交易所有限公司（以下简称"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（以下简称"本次发行上 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。 鉴于本次发行上市的认购对象仅限于符合相关条件的境外投资者及依据中国 相关法律法规有权进行境外证券投资的境内合格投资者，公司将不会在境内证券 交易所的网站和符合监管机构规定条件的媒体上刊登该申请资料，但为使境内投 资者及时了解该等申请资料披露的本次发行上市以及公司的其他相关信息，现提 供该申请资料在香港联交所网站的查询链接供查阅： 中文： 本公司及董事会全 ...

本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有 虚假记载、误导性陈述或重大遗漏。 近日，长春高新技术产业（集团）股份有限公司（以下简称"公司"）子公 司长春金赛药业有限责任公司（以下简称"金赛药业"）收到国家药品监督管理 局核准签发的《药品注册证书》，其申报的替勃龙片已在境内获批上市，现将相 关情况公告如下： 一、药品的基本情况 产品名称：替勃龙片 证券代码：000661 证券简称：长春高新 公告编号：2025-131 长春高新技术产业（集团）股份有限公司 关于子公司替勃龙片在境内获批上市的公告 替勃龙片原研由N.V.Organon研发。金赛药业研发的替勃龙片是针对当前未 满足的市场和临床需求研发的一款仿制药。根据已完成的一项"中国绝经后健康 女性受试者空腹/餐后单次口服替勃龙片和利维爱®的单中心、随机、开放、两序 列、四周期、完全重复交叉设计的生物等效性试验"的临床试验结果显示，与原 研药物相比，金赛药业研发的替勃龙片达到生物等效，且安全性良好，可为绝经 女性的低雌激素症状的治疗提拱更多选择。 获批适应症：治疗妇女自然绝经和手术绝经所引起的低雌激素症状。对于所 有患者，应根据对患者的总体风险 ...

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]