Core Viewpoint - Changchun High-tech (000661.SZ) announced that its subsidiary, Jinsai Pharmaceutical, has received acceptance from the US FDA for the clinical trial application of GenSci143, a dual-specific antibody-drug conjugate targeting B7-H3 and PSMA for the treatment of advanced solid tumors [1] Group 1 - GenSci143 is independently developed by Jinsai Pharmaceutical [1] - The clinical trial application for GenSci143 has also been accepted by the National Medical Products Administration in China [1]

证券代码：000661 证券简称：长春高新 公告编号：2025-135 长春高新技术产业（集团）股份有限公司 关于子公司注射用 GenSci143 境外生产药品注册临床试验申请 获得受理的公告 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"）收到美国食品药品 监督管理局（以下简称"FDA"）书面通知，金赛药业注射用 GenSci143 临床试 验申请获得受理，现将相关情况公告如下： 一、药品的基本情况 产品名称：注射用 GenSci143 申请事项：临床试验申请 受理号：177763 申请人：长春金赛药业有限责任公司 审批结论：经审查，决定予以受理。 适应症：晚期实体瘤 二、药品的其它情况 B7 同源物 3（B7 homologue 3，B7-H3）是一种Ⅰ型跨膜糖蛋白，其在多种 恶性肿瘤中呈现显著高表达，包括非小细胞肺癌、胰腺癌、肝细胞癌、结直肠癌、 乳腺癌、前列腺癌、头颈部鳞癌及黑色素瘤等。前列腺特异性膜抗原 （Prostate-spe ...

Group 1: Company Overview - Changchun High-tech Industry (Group) Co., Ltd. is located in Changchun, Jilin Province, and was established on June 10, 1993, with its listing date on December 18, 1996 [2] - The company primarily engages in the research, production, and sales of biopharmaceuticals and traditional Chinese medicine, with real estate development and property management as supplementary businesses [2] - The revenue composition of the company is as follows: pharmaceuticals 92.83%, real estate 6.81%, and services 0.36% [2] Group 2: Financial Performance - For the first half of 2025, the company achieved operating revenue of 6.603 billion yuan, a year-on-year decrease of 0.54%, and a net profit attributable to shareholders of 983 million yuan, a year-on-year decrease of 42.85% [2] - The company has cumulatively distributed dividends of 4.791 billion yuan since its A-share listing, with 3.259 billion yuan distributed in the last three years [3] Group 3: Stock Performance and Market Activity - As of October 16, the stock price of Changchun High-tech fell by 2.01% to 124.61 yuan per share, with a trading volume of 453 million yuan and a turnover rate of 0.90% [1] - Year-to-date, the stock price has increased by 28.62%, but it has decreased by 3.59% in the last five trading days [1] - The company has appeared on the "Dragon and Tiger List" twice this year, with the most recent appearance on September 2, where it recorded a net purchase of 275 million yuan [1]

Core Viewpoint - Changchun High-tech has submitted an application for overseas listing (H shares) on the Hong Kong Stock Exchange, following a significant decline in its stock price, which has dropped over 70% since 2021 due to price reductions in its core product, growth hormone, resulting in a projected decline in revenue and net profit for 2024 and the first half of 2025 [2][10]. Financial Performance - In 2024, Changchun High-tech's revenue is expected to be 13.466 billion yuan, a year-on-year decrease of 7.55%, while net profit is projected at 2.583 billion yuan, down 43.01% [4]. - For the first half of 2025, the company anticipates revenue of 6.603 billion yuan, a slight decline of 0.54%, and a net profit of 983 million yuan, down 42.85% [4]. - The gross profit margin from drug sales has decreased from 91.6% in 2022 to 88.6% in the first half of 2025 [6]. Core Business Impact - The main revenue and profit contributions come from the growth hormone business of Jinsai Pharmaceutical, which saw a revenue of 10.671 billion yuan in 2024, down 3.73%, and a net profit of 2.678 billion yuan, down 40.67% [10]. - In the first half of 2025, Jinsai Pharmaceutical's revenue was 5.469 billion yuan, a year-on-year increase of 6.17%, but net profit decreased by 37.35% to 1.108 billion yuan [10]. - The vaccine business of Baike Biotechnology also faced challenges, with revenue dropping to 1.229 billion yuan in 2024, down 32.64%, and a net profit of 232 million yuan, down 53.67% [11]. Market Challenges - The growth hormone product has been included in centralized procurement in several provinces since 2022, leading to significant price reductions and increased competition from similar products [10]. - The company's international revenue remains low, with only 130 million yuan in 2024, accounting for 0.97% of total revenue, and 1.13% in the first half of 2025 [12].

Core Viewpoint - Changchun High-tech has submitted an application for overseas listing (H shares) on the Hong Kong Stock Exchange, following a significant decline in its stock price, which has dropped over 70% since 2021 [2][3]. Financial Performance - In 2024, Changchun High-tech's revenue and net profit are expected to decline for the first time in nearly 20 years, with projected revenue of 13.466 billion yuan, a decrease of 7.55%, and net profit of 2.583 billion yuan, down 43.01% [6][7]. - For the first half of 2025, the company is projected to report revenue of 6.603 billion yuan, a slight decrease of 0.54%, and a net profit of 983 million yuan, down 42.85% [8]. - The gross margin for drug sales has decreased from 91.6% in 2022 to 88.6% in the first half of 2025 [10]. Core Business Impact - The main revenue and profit contributions come from two subsidiaries: Jinsai Pharmaceutical and Baike Biological, both of which have experienced declining gross margins from 93.5% to 90.9% and from 87.2% to 78.4%, respectively, from 2022 to the first half of 2025 [12][13]. - Jinsai Pharmaceutical's revenue is projected to be 10.671 billion yuan in 2024, down 3.73%, with a net profit of 2.678 billion yuan, a decrease of 40.67% [16]. - Baike Biological is expected to report revenue of 1.229 billion yuan in 2024, down 32.64%, and a net profit of 232 million yuan, down 53.67% [17]. Market Challenges - The decline in revenue and profit is attributed to the inclusion of growth hormone products in centralized procurement programs across various provinces, leading to significant price reductions [16]. - The company faces increased competition as similar products from other companies have entered the market, disrupting its previous monopoly [16]. - The international expansion of Changchun High-tech remains in its early stages, with overseas revenue accounting for only 0.97% in 2024 and 1.13% in the first half of 2025 [17].

Group 1 - The Shenzhen State-Owned Enterprises Shareholder Return Index (470064) closed at 2334.29 points, up 1.05%, with a trading volume of 39.892 billion yuan and a turnover rate of 1.5% on October 15 [1] - Among the index constituents, 31 stocks rose, with Shenhuo Co., Ltd. leading with a 5.9% increase, while 11 stocks fell, with Fuan Energy leading the decline at 3.99% [1] - The top ten constituents of the index include BOE Technology Group (9.64% weight), Wuliangye Yibin (7.95% weight), and Hikvision (7.72% weight), with total market capitalizations of 153.397 billion yuan, 473.828 billion yuan, and 305.832 billion yuan respectively [1] Group 2 - The net inflow of main funds into the index constituents totaled 0.987 billion yuan, while retail investors experienced a net outflow of 0.882 billion yuan [1] - Detailed fund flow data shows that Chang'an Automobile had a net inflow of 0.651 billion yuan from main funds, while retail investors had a net outflow of 0.386 billion yuan [2] - Other notable stocks include BOE Technology Group with a net inflow of 0.221 billion yuan from main funds and a net outflow of 0.735 billion yuan from retail investors [2]

Core Points - The Bioeconomy Index (970038) closed at 2319.65 points, up 1.32%, with a trading volume of 23.929 billion yuan and a turnover rate of 1.64% [1] - Among the index constituents, 39 stocks rose while 11 fell, with Boteng Co., Ltd. leading the gainers at 6.85% and Dabo Medical leading the decliners at 2.94% [1] Index Constituents Summary - The top ten constituents of the Bioeconomy Index include: - Mindray Medical (sz300760) with a weight of 13.81%, latest price at 230.50, and a market cap of 279.468 billion yuan [1] - Changchun High-tech (sz000661) with a weight of 5.41%, latest price at 127.16, and a market cap of 51.873 billion yuan [1] - Kanglong Chemical (sz300759) with a weight of 4.66%, latest price at 31.35, and a market cap of 55.746 billion yuan [1] - Other notable constituents include Taige Pharmaceutical, Deep Technology, and Muyuan Foods, each with varying weights and market caps [1] Capital Flow Analysis - The Bioeconomy Index constituents experienced a net inflow of 265 million yuan from institutional investors, while retail investors saw a net outflow of 72.932 million yuan [3] - Key stocks with significant capital flow include: - Mindray Medical with a net inflow of 79.5868 million yuan from institutional investors [3] - Xintai (002294) with a net inflow of 66.974 million yuan, but a net outflow of 87.6434 million yuan from retail investors [3] - Changchun High-tech also saw a net inflow of 66.9424 million yuan from institutional investors, with a notable outflow from retail investors [3]

Core Insights - The Medical Health Index (980016) closed at 6759.45 points, up 1.78%, with a trading volume of 27.946 billion yuan and a turnover rate of 1.0% [1] - Among the index constituents, 40 stocks rose, with Huahai Pharmaceutical leading at a 7.59% increase, while 9 stocks fell, with BGI Genomics leading the decline at 2.93% [1] Index Performance - The Medical Health Index saw a net inflow of 1.063 billion yuan from main funds, while retail investors experienced a net outflow of 392 million yuan [1] - The top ten constituents of the index include major companies such as WuXi AppTec, Hengrui Medicine, and Mindray Medical, with varying market capitalizations and price changes [1] Fund Flow Analysis - Huahai Pharmaceutical had a main fund net inflow of 163 million yuan, while retail investors saw a net outflow of 76.6 million yuan [2] - Other notable companies with significant fund flows include Aier Eye Hospital and Hengrui Medicine, both experiencing mixed inflows and outflows from different investor categories [2]

Core Insights - The innovative drug sector in Hong Kong has experienced significant volatility, with the Hang Seng Healthcare Index dropping 6.33% in a week, marking the largest weekly decline since the second half of 2025 [4][10] - The recent surge in IPOs for innovative drug companies in Hong Kong is attributed to favorable policies and improved market liquidity, with notable companies like Betta Pharmaceuticals and Changchun High-tech expected to achieve "A+H" listings [5][6] - The first domestic IL-36R monoclonal antibody has been submitted for approval to treat adult generalized pustular psoriasis, indicating advancements in innovative drug development [12][13] Market Performance - The pharmaceutical and biotechnology index fell by 1.66% from October 6 to October 10, underperforming the Shanghai Composite Index by 0.72 percentage points, continuing a trend of underperformance for three consecutive weeks [4] - The innovative drug index saw a decline of 1.09% over the same period, with the Hong Kong innovative drug ETF dropping 3.98% [4] IPO Trends - A notable increase in IPO activity for innovative drug companies has been observed, with a focus on various cutting-edge fields such as small molecule drugs and antibody-drug conjugates [5] - The Hong Kong Stock Exchange has relaxed public shareholding requirements for "A+H" companies, facilitating more A-share companies to list in Hong Kong [5] Clinical Trials - Recent data indicates that 85 clinical trial registrations were disclosed by the National Medical Products Administration, with 29 of these being innovative drugs in Phase II or higher, primarily targeting autoimmune diseases and tumors [6] Business Development (BD) Insights - The recent downturn in the innovative drug sector is linked to a cooling off of high-profile business development transactions, with market expectations having been previously overstated [10][11] - The total transaction amount for related deals in the first half of the year reached $60.8 billion, reflecting a 129% year-on-year increase [10] Future Outlook - The upcoming European Society for Medical Oncology (ESMO) annual meeting is expected to showcase 23 studies from China, highlighting the potential for innovative drugs to gain international recognition [11] - The market is advised to focus on clinical data and competitive landscapes as the sector transitions from high BD activity to a more fundamental-driven approach [11]

Market Overview - The biopharmaceutical sector experienced a decline of 1.28% on October 13, with Baipusais leading the drop [1] - The Shanghai Composite Index closed at 3889.5, down 0.19%, while the Shenzhen Component Index closed at 13231.47, down 0.93% [1] Stock Performance - Notable gainers in the biopharmaceutical sector included: - Teabo Bio (688278) with a closing price of 83.89, up 2.91% [1] - ST Sihuan (000518) with a closing price of 2.42, up 2.11% [1] - Wanzhe Co. (000534) with a closing price of 15.88, up 1.99% [1] - Major decliners included: - Baipusais (301080) with a closing price of 57.65, down 6.11% [2] - Changchun High-tech (000661) with a closing price of 132.06, down 3.11% [2] - Tibet Pharmaceutical (600211) with a closing price of 47.50, down 2.84% [2] Capital Flow - The biopharmaceutical sector saw a net outflow of 432 million yuan from institutional investors, while retail investors contributed a net inflow of 246 million yuan [2] - The capital flow for specific stocks showed: - Changchun High-tech (000661) had a net outflow of 51.35 million yuan from institutional investors [3] - Baipusais (301080) experienced a net inflow of 8.11 million yuan from institutional investors [3] - SanSheng GuoJian (688336) had a net inflow of 9.14 million yuan from institutional investors [3]