Core Viewpoint - The company, Baicheng Pharmaceutical, has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug BIOS-0625 tablets, aimed at treating ulcerative colitis, a chronic and recurrent inflammatory bowel disease [1] Group 1: Drug Development - BIOS-0625 tablets are a new drug developed by the company targeting ulcerative colitis, which currently has no other drugs with the same indication on the market [1] - The drug is classified as a Class 1 chemical drug and is categorized as an innovative drug that has not been marketed domestically or internationally [1] Group 2: Market Challenges - Ulcerative colitis presents persistent treatment challenges due to its chronic and recurrent nature, characterized by "non-curability and recurrence" [1] - Traditional medications can only provide short-term symptom relief and are limited by three major bottlenecks: low efficacy ceiling, significant adverse reactions, and poor patient tolerance [1] Group 3: Importance of New Therapies - New molecules and therapies are essential for improving patients' quality of life and serve as a critical bridge connecting translational medicine with long-term patient benefits [1]

Core Viewpoint - The company, Baicheng Pharmaceutical, has received clinical trial approval from the National Medical Products Administration for its innovative drug BIOS-0625 tablets, aimed at treating ulcerative colitis, marking a significant step in its drug development pipeline [1] Group 1: Drug Development - BIOS-0625 tablets are a novel drug developed by the company, targeting a new mechanism for the treatment of ulcerative colitis, with no similar indication drugs currently available on the market [1] - The drug is classified as a Class 1 chemical drug, indicating it is an innovative drug that has not been marketed domestically or internationally [1] Group 2: Regulatory Approval - The approval notification for clinical trials signifies a critical milestone in the drug's development process, although it comes with inherent uncertainties regarding the progress and outcomes of the clinical trials [1] - The company faces risks related to the clinical trial timeline and the potential for the product to receive market approval [1]

Core Viewpoint - The company has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative drug BIOS-0625, aimed at treating ulcerative colitis [1] Group 1 - The drug BIOS-0625 is classified as a Class 1 medication [1] - The clinical trial application for BIOS-0625 was accepted by NMPA on August 28, 2025 [1] - The clinical trials will focus on the treatment of ulcerative colitis [1]

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。 杭州百诚医药科技股份有限公司（以下简称"公司"）近日获悉，公司自主研发 的创新药 BIOS-0625 片获得国家药品监督管理局（NMPA）临床试验批准通知书。现将 情况公告如下： 杭州百诚医药科技股份有限公司 关于创新药BIOS-0625片获得临床试验批准通知书的公告 证券代码：301096 证券简称：百诚医药 公告编号：2025-056 受理号：CXHL2500907、CXHL2500908 一、药品基本情况 目前所处审批阶段：IND 获批（临床试验获批） 审批结论：根据《中华人民共和国药品管理法》及有关规定， 2025 年 8 月 28 日受理的 BIOS-0625 片临床试验申请符合药品注册的有关要求，同意本品开展用于治 疗溃疡性结肠炎的临床试验。 二、药品的其他情况 溃疡性结肠炎作为一种慢性复发性肠道炎症性疾病，其"不可根治、反复发作"的 病程特征构成了持久的治疗挑战。传统药物虽能短期缓解症状，却长期受制于三大瓶 颈：疗效天花板低、不良反应显著、患者耐受性差。新分子，新疗法既是改善患者生 活质量的基石，更 ...

Core Insights - On November 6, Baicheng Pharmaceutical experienced a decline of 3.41% with a trading volume of 706 million yuan, indicating market volatility [1] - The company reported a financing buy-in of 78.38 million yuan and a financing repayment of 133 million yuan on the same day, resulting in a net financing outflow of 54.65 million yuan [1] - As of November 6, the total margin balance for Baicheng Pharmaceutical was 400 million yuan, representing 6.77% of its market capitalization, which is above the 90th percentile of the past year [1] Financial Performance - For the period from January to September 2025, Baicheng Pharmaceutical achieved a revenue of 510 million yuan, reflecting a year-on-year decrease of 29.33% [2] - The net profit attributable to the parent company was 6.12 million yuan, showing a significant decline of 95.68% compared to the previous year [2] Shareholder Information - As of September 30, 2025, the number of shareholders for Baicheng Pharmaceutical was 10,100, a decrease of 15.05% from the previous period [2] - The average number of circulating shares per shareholder increased by 18.15% to 8,242 shares [2] Dividend Distribution - Since its A-share listing, Baicheng Pharmaceutical has distributed a total of 184 million yuan in dividends, with 119 million yuan distributed over the past three years [3] Institutional Holdings - As of September 30, 2025, the top ten circulating shareholders of Baicheng Pharmaceutical saw the exit of the Rongtong Health Industry Flexible Allocation Mixed A/B fund from the list [3]

Investment Rating - The investment rating for the company is "Outperform the Market" [4] Core Views - The company has faced performance pressure in the first three quarters of 2025, with revenue of 510 million yuan, a decrease of 29.33%, and a net profit attributable to shareholders of 6 million yuan, down 95.68% [1] - The company is continuing its innovation transformation, with a focus on enhancing the production capacity of its subsidiary, and has a pipeline of over 15 innovative drugs, particularly in the fields of neurology, autoimmune diseases, and oncology [2] - Revenue forecasts for 2025-2027 are maintained at 730 million, 790 million, and 850 million yuan, with expected year-on-year growth rates of -9%, 8%, and 8% respectively [2] Financial Performance Summary - For the first three quarters of 2025, the gross margin was 48.98%, down 12.19 percentage points, influenced by price competition and low capacity utilization [1] - The company’s operating expenses have increased, with a management expense ratio of 16.15%, up 9.85 percentage points, indicating a significant rise in management costs [1] - The projected earnings per share for 2025 is 0.49 yuan, with a PE ratio of 115.2x, reflecting the company's current valuation [3][22]

Core Viewpoint - Baicheng Pharmaceutical (301096.SZ) is currently experiencing a decline in stock price, closing at 54.08 yuan with a drop of 3.41%, indicating it is in a state of underperformance since its IPO [1] Group 1: IPO Details - Baicheng Pharmaceutical was listed on the Shenzhen Stock Exchange's ChiNext board on December 20, 2021, with an initial issuance of 27.0417 million shares at a price of 79.60 yuan per share [1] - The stock reached a peak price of 120 yuan on its first trading day, marking the highest price since its listing [1] - The total funds raised from the IPO amounted to 2.153 billion yuan, with a net amount of 1.863 billion yuan after deducting issuance costs, exceeding the original plan by 1.213 billion yuan [1] Group 2: Fund Utilization - The company intended to raise 651 million yuan, which was planned to be used entirely for the headquarters and R&D center project of Hangzhou Baicheng Pharmaceutical Technology Co., Ltd. [1] - The total issuance costs for the IPO were 289 million yuan, including underwriting and sponsorship fees of 262 million yuan [1]

Core Points - Baicheng Pharmaceutical announced on November 5 that its directors and senior management plan to reduce their shareholdings [1] Summary by Category Shareholding Reduction - Director and senior management member Jia Fei holds 48,908 shares (0.0451% of total shares) and plans to reduce his holdings by up to 12,200 shares (0.0112% of total shares) within three months after the disclosure of the reduction plan [1] - Senior management member Chen An holds 45,000 shares (0.0415% of total shares) and plans to reduce his holdings by up to 11,200 shares (0.0103% of total shares) within the same timeframe [1] - The company has received notifications from Jia Fei and Chen An confirming the completion of their share reduction plans [1]

Company Overview - Baicheng Pharmaceutical (SZ 301096) announced on November 5 that directors and senior management, Mr. Jia Fei and Mr. Chen An, have completed their share reduction plan, collectively reducing approximately 23,400 shares, which accounts for 0.0215% of the company's total shares [1] Financial Performance - For the first half of 2025, Baicheng Pharmaceutical's revenue composition is as follows: CRO business accounts for 86.22%, commercial production accounts for 10.28%, and CDMO business accounts for 3.5% [1] - As of the report date, Baicheng Pharmaceutical's market capitalization is 6.1 billion yuan [1]

Summary of Key Points Core Viewpoint - Baicheng Pharmaceutical (301096.SZ) experienced a significant decline in stock price, closing at 55.99 yuan with a drop of 9.03%, indicating a state of breaking down [1]. Company Overview - Baicheng Pharmaceutical was listed on the Shenzhen Stock Exchange's ChiNext board on December 20, 2021, with an initial issuance of 27.04 million shares at a price of 79.60 yuan per share [1]. - The stock reached a peak price of 120 yuan on its first trading day, marking the highest price since its listing [1]. Fundraising Details - The total amount raised from the initial public offering (IPO) was 2.153 billion yuan, with a net amount of 1.863 billion yuan after deducting issuance costs [1]. - The net amount raised exceeded the original plan by 1.213 billion yuan, as the company initially aimed to raise 651 million yuan for its headquarters and R&D center in Hangzhou [1]. - The total issuance costs for the IPO were 289 million yuan, which included underwriting and sponsorship fees of 262 million yuan [1].