Core Viewpoint - Yuan Dong Bio is focusing on innovation-driven development in the biopharmaceutical sector, with a comprehensive industrial layout in chemical raw materials, high-end chemical drugs, and biological drugs [1] Summary by Relevant Sections Innovation Drug Development - The company has over 80 ongoing research projects, with innovative drug projects accounting for 24.4% of the total, including small molecule new drugs, biological drugs, and modified new drugs [1] - In the small molecule new drug category, the drug "Yoglitin Tablets" has achieved the expected goals in its Phase III clinical trial, while EP-0108 capsules, EP-0146 tablets, and EP-0186 tablets have received clinical trial approvals [1] - In the biological drug sector, the anesthetic and analgesic drug EP-9001A monoclonal antibody has completed Phase Ib clinical trials, and the ADC innovative drug YLSH003 has submitted an IND and received clinical approval [1] - Several modified new drugs, such as oral solution of chloral hydrate and extended-release oxycodone tablets, have been submitted for production, with multiple distinctive modified new drugs entering clinical stages [1] Strategic Investments and Collaborations - The company is actively tracking global cutting-edge technologies and accelerating its innovation transformation through strategic investments, external introductions, and collaborative development [1] - Following the acquisition of shares in Shanghai Chaoyang, the company's indirect shareholding increased from 11.36% to 30.68%, and it plans to further increase its stake to achieve controlling interest, raising its indirect ownership to 51.48% [1] - This strategic control over Shanghai Chaoyang will enhance the company's pipeline in frontier technology areas such as molecular glue, PROTAC (proteolysis-targeting chimeras), and DAC (drug-antibody conjugates), strengthening its R&D capabilities in innovative drugs [1]

Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the registration of its drug, Ethyl Pheylbutazone Tablets, marking a significant milestone for the company in the pharmaceutical market [1][2]. Drug Basic Information - Drug Name: Ethyl Pheylbutazone Tablets - Dosage Form: Tablets - Specification: 50mg - Registration Category: Chemical Drug Class 4 - Validity Period: 18 months - Holder of Marketing Authorization: Chengdu Shode Pharmaceutical Co., Ltd. - Production Company: Chengdu Shode Pharmaceutical Co., Ltd. - Registration Standard Number: YBH23792025 - Acceptance Number: CYHS2402415 - Certificate Number: 2025S02973 - Approval Document Number: Guoyao Zhunzi H20255554 - Approval Conclusion: The drug meets the registration requirements as per the relevant laws and regulations [1]. Drug Indications and Market Context - The primary active ingredient is Ethyl Pheylbutazone, indicated for conditions such as cervical, shoulder, and lumbar pain, as well as various spastic paralysis conditions [2]. - The drug was originally developed by Eisai Co., Ltd. in Japan and was first approved for sale in Japan in February 1983, later imported to China in July 2004 [2]. - It is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Directory (2024) [2]. - The drug is the first generic drug approved under the new registration classification, equivalent to passing the consistency evaluation [2]. - Sales data from major public hospitals indicate that the expected sales for Ethyl Pheylbutazone Tablets in 2024 are approximately 102.61 million yuan, reflecting a year-on-year growth of 14.01% [2]. Impact on the Company - The approval of Ethyl Pheylbutazone Tablets signifies that the product meets the necessary registration requirements, although it is not expected to have a significant impact on the company's short-term performance [3]. - The period from approval to market production may face uncertainties, and the company will fulfill its information disclosure obligations as required by law [3].

Core Viewpoint - Chengdu Yuandong Pharmaceutical Co., Ltd. has received the drug registration certificate for its product, Hydrochloride Ephedrine Tablets, marking a significant milestone in its product portfolio and compliance with regulatory standards [1][2]. Drug Basic Information - Drug Name: Hydrochloride Ephedrine Tablets - Dosage Form: Tablets - Specification: 50mg - Registration Category: Class 4 Chemical Drug - Validity Period: 18 months - Holder of Marketing Authorization: Chengdu Shuo De Pharmaceutical Co., Ltd. - Production Company: Chengdu Shuo De Pharmaceutical Co., Ltd. - Drug Registration Standard Number: YBH23792025 - Approval Conclusion: The product meets the requirements for drug registration and has been granted a registration certificate [1][2]. Drug Indications - Hydrochloride Ephedrine Tablets are indicated for: 1. Improving muscle tension in conditions such as cervical shoulder-arm syndrome, periarthritis of the shoulder, and low back pain 2. Spastic paralysis caused by cerebrovascular disorders, spastic myelopathy, cervical spondylosis, postoperative sequelae, traumatic sequelae, amyotrophic lateral sclerosis, infantile cerebral palsy, and other spinal cord diseases [2]. Market Performance - The sales amount for Hydrochloride Ephedrine Tablets in public hospitals in key provinces and cities is projected to be approximately 102.61 million yuan in 2024, reflecting a year-on-year growth of 14.01% [3]. Impact on the Company - The approval of Hydrochloride Ephedrine Tablets signifies that the product meets the necessary registration requirements and is considered to have passed the consistency evaluation. However, it is noted that the approval will not have a significant impact on the company's short-term performance [4].

Core Viewpoint - The company Yuandong Biotech (688513.SH) announced that its wholly-owned subsidiary Chengdu Shode Pharmaceutical Co., Ltd. has received the drug registration certificate from the National Medical Products Administration for its product, Etifoxine Hydrochloride Tablets [1] Group 1: Product Information - The drug Etifoxine Hydrochloride Tablets is primarily indicated for improving muscle tension states associated with conditions such as cervical shoulder-arm syndrome, periarthritis of the shoulder, and low back pain [1] - Additional indications include treatment for spastic paralysis caused by cerebrovascular disorders, spastic myelopathy, cervical spondylosis, postoperative sequelae (including brain and spinal cord tumors), and post-traumatic sequelae (such as spinal cord injury and head trauma) [1] - The drug is also indicated for conditions like amyotrophic lateral sclerosis, infantile cerebral palsy, spinocerebellar degeneration, spinal vascular disorders, subacute optic neuritis myelitis (SMON), and other brain and spinal cord diseases that lead to spastic paralysis [1]

Core Viewpoint - Company Yuandong Biotech (688513.SH) has received approval from the National Medical Products Administration for its drug, Ephedrine Hydrochloride Tablets, which is expected to address various medical conditions related to muscle tension and spastic paralysis [1] Group 1: Drug Approval - The company's wholly-owned subsidiary, Chengdu Shode Pharmaceutical Co., Ltd., has been granted a Drug Registration Certificate for Ephedrine Hydrochloride Tablets [1] - The approval signifies a significant milestone for the company in expanding its pharmaceutical portfolio [1] Group 2: Indications and Uses - Ephedrine Hydrochloride Tablets are indicated for improving conditions such as cervical shoulder-arm syndrome, periarthritis of the shoulder, and low back pain related to muscle tension [1] - The drug is also applicable for various neurological and muscular disorders, including cerebrovascular disorders, spastic myelopathy, cervical spondylosis, and post-surgical sequelae [1]

Core Viewpoint - Yuan Dong Biotech (688513) announced the approval of its subsidiary Chengdu Shuo De Pharmaceutical's drug registration certificate for Ephedrine Hydrochloride Tablets by the National Medical Products Administration [1] Group 1 - The active ingredient of Ephedrine Hydrochloride Tablets is Ephedrine Hydrochloride [1] - The primary indications for the drug include improvement of muscle tension conditions related to cervical shoulder-arm syndrome, periarthritis of the shoulder, low back pain, cerebrovascular disorders, spastic myelopathy, cervical spondylosis, and postoperative sequelae [1]

Core Viewpoint - Yuan Dong Biotech (688513.SH) announced that its wholly-owned subsidiary Chengdu Shuo De Pharmaceutical Co., Ltd. has received the Drug Registration Certificate approved by the National Medical Products Administration for its product, Ephedrine Hydrochloride Tablets [1] Group 1: Company Developments - Chengdu Shuo De Pharmaceutical has been granted approval for Ephedrine Hydrochloride Tablets, which is a significant milestone for the company [1] - The active ingredient of the tablets is Ephedrine Hydrochloride, indicating the company's focus on addressing various medical conditions [1] Group 2: Product Indications - The primary indications for Ephedrine Hydrochloride Tablets include improving muscle tension states in conditions such as cervical shoulder-arm syndrome, periarthritis of the shoulder, and low back pain [1] - The product is also indicated for spastic paralysis caused by cerebrovascular disorders, spastic myelitis, cervical spondylosis, postoperative sequelae, and other neurological conditions [1]

证券代码：688513 证券简称：苑东生物 公告编号：2025-070 成都苑东生物制药股份有限公司 关于自愿披露盐酸乙哌立松片获得药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 上市许可持有人：成都硕德药业有限公司 生产企业：成都硕德药业有限公司 药品注册标准编号：YBH23792025 受理号：CYHS2402415 成都苑东生物制药股份有限公司（以下简称"公司"）全资子公司成都硕德药 业有限公司（以下简称"硕德药业"）于近日收到国家药品监督管理局（以下简称 "国家药监局"）核准签发的《药品注册证书》，现将相关情况公告如下： 一、药品基本情况 药品名称：盐酸乙哌立松片 剂型：片剂 规格：50mg 注册分类：化学药品 4 类 药品有效期：18 个月 硕德药业盐酸乙哌立松片按化学药品4类注册申报，获批后视同通过一致性 评价。该药品获批，标志着该产品符合药品注册的有关要求，不会对公司近期业 绩产生重大影响。药品获批上市到生产销售期间可能受到一些不确定因素的影响， 公司将及时根据有关法律法规的要求履行信息披 ...

Core Viewpoint - Yuan Dong Biotech (688513.SH) announced that its wholly-owned subsidiary, Shuo De Pharmaceutical, has received the drug registration certificate from the National Medical Products Administration for the drug Etifoxine Hydrochloride Tablets, which is expected to generate approximately 103 million yuan in sales in 2024, reflecting a year-on-year growth of 14.01% [1] Company Summary - The drug Etifoxine Hydrochloride Tablets, with a specification of 50mg, is classified as a Class 4 chemical drug and is indicated for improving muscle tension states associated with conditions such as cervical spondylosis, shoulder periarthritis, and low back pain [1] - The drug was originally developed by Japan's Eisai Co., Ltd. and was first approved for sale in Japan in 1983 [1] - The approval of this drug is considered equivalent to passing the consistency evaluation, and it is not expected to have a significant impact on the company's recent performance [1] Industry Summary - The projected sales figure of approximately 103 million yuan for 2024 indicates a positive growth trajectory for the drug within the market, suggesting a healthy demand for treatments addressing muscle tension related to common musculoskeletal disorders [1]

Group 1 - The core point of the news is that Yuan Dong Bio experienced a 5% drop in stock price, reaching 55.46 CNY per share, with a total market capitalization of 9.79 billion CNY [1] - The company, Chengdu Yuan Dong Bio Pharmaceutical Co., Ltd., was established on June 1, 2009, and went public on September 2, 2020. Its main business involves the research, production, and sales of chemical raw materials and chemical drug formulations [1] - The revenue composition of the company includes 78.75% from formulation sales, 9.22% from raw material sales, 6.79% from technical services and transfers, 4.01% from CMO/CDMO, and 1.22% from other sources [1] Group 2 - From the perspective of fund holdings, one fund under Taiping Fund has a significant position in Yuan Dong Bio. The Taiping Medical Innovation Mixed Fund A (021027) held 11,500 shares in the second quarter, accounting for 3.27% of the fund's net value, ranking as the tenth largest holding [2] - The Taiping Medical Innovation Mixed Fund A (021027) was established on June 4, 2024, with a latest scale of 13.98 million CNY. Year-to-date returns are 56.58%, ranking 854 out of 8171 in its category; the one-year return is 52.42%, ranking 2757 out of 8004; and since inception, the return is 50.71% [2] Group 3 - The fund manager of Taiping Medical Innovation Mixed Fund A (021027) is Lu Lingling, who has been in the position for 1 year and 115 days. The total asset size of the fund is 14.45 million CNY, with the best return during her tenure being 49.45% and the worst return being 48.55% [3]