Core Viewpoint - The company Shuyou Shen (300204.SZ) has recently obtained the Phase I clinical study summary report for STSP-0902 eye drops, indicating positive safety and tolerability results in healthy subjects [1] Group 1: Clinical Study Results - STSP-0902 eye drops demonstrated good overall safety and tolerability with most adverse events classified as CTCAE Grade 1 [1] - All drug-related adverse events were mild and self-limiting localized ocular reactions [1] - Pharmacokinetic results showed that the trial drug was detectable in all tear samples up to 6 hours after a single dose [1] Group 2: Future Research Implications - No systemic drug exposure or immunogenicity was observed after both single and multiple doses [1] - The study results support the initiation of further clinical trials in patients with neurotrophic keratitis [1]

Core Viewpoint - The company has received the Phase I clinical study summary report for STSP-0902 eye drops, indicating positive safety and tolerability results in healthy subjects, supporting further trials in patients with neurotrophic keratitis [1] Group 1: Clinical Study Results - The drug STSP-0902 is intended for the treatment of neurotrophic keratitis [1] - The overall safety and tolerability of the drug were found to be good in both single and multiple dosing in healthy subjects, with most adverse events classified as CTCAE Grade 1 [1] - Pharmacokinetic results showed that the drug was detectable in all tear samples up to 6 hours after a single dose [1] Group 2: Future Implications - The results of the study support the initiation of further clinical trials in patients suffering from neurotrophic keratitis [1]

Core Viewpoint - The company has obtained the Phase I clinical study summary report for STSP-902 eye drops, which are intended for the treatment of neurotrophic keratitis, indicating progress in its clinical development [1] Group 1: Clinical Development - The company plans to submit the clinical trial application for STSP-902 in April 2024, with approval expected in July 2024 and the first subject dosing completed by October 2024 [1] - The study results demonstrate that both single and multiple doses of STSP-902 eye drops show good overall safety and tolerability in healthy subjects, with no systemic drug exposure or immunogenicity observed [1] - Pharmacokinetic results indicate that the trial drug can still be detected in tear samples 6 hours after a single dose administration [1] Group 2: Future Implications - The results support the initiation of further clinical trials in patients with neurotrophic keratitis, suggesting potential for future therapeutic applications [1]

证券代码：300204 证券简称：舒泰神 公告编号：2025-046 1、药品名称：STSP-0902 滴眼液 2、实验题目：一项单次和多次给药剂量递增评价 STSP-0902 滴眼液在健康 受试者中的安全性、耐受性和药代动力学特征的 I 期临床试验 3、适应症：治疗神经营养性角膜炎 舒泰神（北京）生物制药股份有限公司 关于 STSP-0902 滴眼液（用于治疗神经营养性角膜炎） 获得 I 期临床研究总结报告的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假 记载、误导性陈述或重大遗漏。 近日，舒泰神（北京）生物制药股份有限公司（以下简称"舒泰神"或"公 司"）取得 STSP-0902 滴眼液 I 期临床研究总结报告。现将有关情况公告如下： 一、药品的基本情况 4、申办方：舒泰神（北京）生物制药股份有限公司 二、主要研究结论 STSP-0902 滴眼液单次和多次给药在健康受试者中整体安全性和耐受性良 好，大部分不良事件为 CTCAE 1 级，与试验药物相关的不良事件均为轻微且自 限性的眼局部反应。眼局部药代动力学结果显示，单次给药后 6h 所有泪液样本 中仍可检测到试验药物。单次和多次 ...

Group 1 - The A-share pharmaceutical sector has experienced a significant rally this year, with 56 stocks doubling their prices [1][2] - Among the top performers, Shuyou Shen (300204.SZ) has seen a price increase of 6.44 times, reaching a historical high on August 19 [1] - Other notable stocks include Saifen Technology (688758.SH) with a 3.57 times increase and Guangshengtang (300436.SZ) with a 3.55 times increase [1] Group 2 - The overall market has shown strong performance, with 435 out of 494 stocks rising, indicating a nearly 90% increase [1] - The surge in pharmaceutical stocks is attributed to the recognition of innovation capabilities among domestic pharmaceutical companies [2]

Core Viewpoint - The A-share pharmaceutical sector has shown significant growth this year, with nearly 90% of stocks rising, and 56 stocks doubling in price, indicating a recovery in the industry after a period of capital winter [1][4]. Group 1: Market Performance - The A-share market has seen a trading volume exceeding 2 trillion yuan for six consecutive days, with the pharmaceutical sector leading the gains [1]. - Among the stocks, Shuyou Shen (300204.SZ) has the highest cumulative increase of 6.44 times, followed by Saifen Technology (688758.SH) with 3.57 times, and Guangsheng Tang (300436.SZ) with 3.55 times [1]. - Other notable stocks with over 100% increase include Chao Yan Co. (301602.SZ), Yipin Hong (300723.SZ), and several others, indicating a strong upward trend in the sector [1]. Group 2: Industry Dynamics - The recent bullish trend in pharmaceutical stocks is attributed to the recognition of domestic pharmaceutical companies' innovation capabilities [2]. - The industry faced a capital winter due to homogeneous competition and lower-than-expected returns on innovative drugs, but the current performance suggests a recovery [4]. - The number of successful outbound transactions for domestic innovative drugs has reached a record, with 50 projects and a total transaction value exceeding 48.4 billion USD [5]. Group 3: Policy Support - The National Medical Insurance Administration and the National Health Commission have issued measures to support the high-quality development of innovative drugs, signaling strong governmental backing for the industry [7]. - The introduction of dual directories for medical insurance and commercial insurance for innovative drugs represents a significant innovation in the policy landscape, enhancing the payment capabilities for innovative drugs [7]. - The current policy environment is seen as favorable for the growth of the innovative drug sector, contributing to a positive outlook for the industry [7].

Group 1 - The value of domestic innovative drugs is undergoing a reassessment, with the A-share pharmaceutical sector showing significant performance this year, as nearly 90% of the 494 stocks have risen, and 56 stocks have doubled in price [1][3] - Notable stock performances include Shuyou Shen with a price increase of 6.44 times, followed by Saifen Technology at 3.57 times, and Guangshengtang at 3.55 times [1] - The recent surge in pharmaceutical stocks is attributed to the recognition of the innovation capabilities of domestic pharmaceutical companies [1][3] Group 2 - The innovative drug industry faced a capital winter due to homogenized competition and lower-than-expected returns, but the current performance indicates a recovery phase [3] - In the first half of this year, domestic innovative drugs achieved record-breaking overseas transactions, with 50 business development projects totaling over $48.4 billion, reflecting global confidence in China's clinical data and R&D capabilities [4] - The surge in business development activities among domestic pharmaceutical companies indicates a growing recognition of the value of Chinese medical innovation [4][5] Group 3 - Recent government policies, including measures to support high-quality development of innovative drugs, have provided strong backing for the industry [5] - The simultaneous launch of basic medical insurance and commercial insurance drug directories marks a significant innovation in the adjustment of the medical insurance directory, enhancing the multi-payment capability for innovative drugs [5]

Market Overview - The market experienced a day of high-level consolidation after two consecutive days of strength, with the Shanghai Composite Index, Shenzhen Component Index, and ChiNext Index closing down slightly by 0.02%, 0.12%, and 0.17% respectively [4] - Nearly 3,000 stocks rose while over 2,200 stocks fell, indicating a mixed market sentiment [4] Innovation Drugs Sector - The innovation drug and pharmaceutical sectors saw a strong opening, with multiple stocks hitting the daily limit, including Jimin Health with four consecutive limit-ups and Shunlian Bio with a 20% increase [5][7] - The innovation drug sector initially surged nearly 2.5% but ended the day with a modest gain of 0.13% [8] - The sector is favored by institutions, driven by the acceleration of Chinese pharmaceutical companies entering overseas markets, with the potential market size increasing from $50 billion domestically to over $420 billion in the U.S. market alone [9] - Analysts suggest that the domestic innovation drug industry is at a turning point, transitioning from a decade of preparation to realizing innovative results [10] Media Sector - The media sector, which had a significant rise previously, saw a mixed performance following the announcement of new initiatives by the National Radio and Television Administration aimed at enhancing content supply [19] - The sector's leading stock, Ciweng Media, achieved two consecutive limit-ups, but overall performance was lackluster, with many stocks opening lower or declining [21] Oriental Selection - Oriental Selection's stock experienced a dramatic rise of over 23% during the afternoon session, reflecting a significant rebound over the past two months, with the stock price nearly quintupled [23][24] - However, the stock faced a sharp decline later, with a drop exceeding 20% and an intraday retreat of over 35%, indicating volatility and potential profit-taking behavior [25][26][27]

Market Performance - The trading volume of the Shanghai, Shenzhen, and Beijing markets exceeded 2 trillion yuan for the fifth consecutive trading day, marking a significant increase in market activity [7][8] - The last occurrence of such sustained trading volume was in November of the previous year [8] Stock Highlights - Shuotai Shen became the second "10-bagger" of the year, with its stock price soaring to 66.66 yuan, representing a maximum increase of 10.3 times from its low in April [4] - Cambricon Technologies' stock price reached a new high of 1001.10 yuan, marking its entry into the "thousand yuan club" for the first time [5] - Agricultural Bank of China continued to set historical highs, with its stock price surpassing 7 yuan and a total market capitalization nearing 2.4 trillion yuan [6] Historical Highs and Doubling Stocks - A total of 99 stocks reached historical highs today, including eight stocks with a market capitalization exceeding 100 billion yuan, such as Agricultural Bank, Industrial Fulian, and Cambricon [8] - The number of stocks that have doubled in price this year has risen to 357, with Shuotai Shen and *ST Yushun following the leader, Shuangwei New Materials, which has a 12-fold increase [9]

Group 1 - The core viewpoint of the articles highlights a significant surge in the innovative drug sector, with companies like Shenlian Bio and Boji Pharmaceutical reaching their historical highs, indicating a shift from "follower" to "leader" in China's innovative drug industry [1] - The current phase of China's innovative drug industry is identified as the 3.0 era, with expectations for 2025 to be a pivotal year for the overseas explosion of Chinese innovative drugs, with many products projected to exceed peak sales of $3 billion to $5 billion [1] - The investment opportunities in the innovative drug sector this year are anticipated to be greater than those in 2020-2021, driven by ongoing advancements and record-breaking licensing transactions [1] Group 2 - The National Medical Insurance Administration has recently published the preliminary list of drugs for the 2025 National Medical Insurance Drug Directory and commercial insurance innovative drug directory, with several cancer drugs and new drugs in chronic disease areas passing initial reviews [2] - The innovative drugs set to be included in the medical insurance and commercial insurance directories are mostly at a low base stage, suggesting potential for rapid growth as policy support continues to be released [2] - As the mid-year reporting season approaches, there are recommendations for investment opportunities based on the performance of companies in the second half of the year [2]