苑东生物(688513.SH)艾拉莫德片获得药品注册证书发布公告，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》，涉及药品："艾拉莫德片"。 艾拉莫德片活性成份为艾拉莫德，适应症为活动性类风湿关节炎。艾拉莫德片属于《国家基本医疗保 险、工伤保险和生育保险药品目录(2024年)》乙类品种。 ...

Core Viewpoint - Yuan Dong Biotech (688513.SH) has received a drug registration certificate for Elamomide tablets, indicating a significant regulatory approval for the company’s product aimed at treating active rheumatoid arthritis [1] Group 1: Company Information - The drug Elamomide, developed by the company's wholly-owned subsidiary Chengdu Shuo De Pharmaceutical Co., Ltd., has been approved by the National Medical Products Administration (NMPA) [1] - Elamomide tablets are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1]

Core Viewpoint - Yuan Dong Biotech (688513) announced the approval of its subsidiary Chengdu Shuo De Pharmaceutical Co., Ltd. for the drug registration certificate of Elamomab tablets by the National Medical Products Administration [1] Company Summary - The active ingredient of Elamomab tablets is Elamomab, which is indicated for the treatment of active rheumatoid arthritis [1] - Elamomab tablets are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2024) [1]

Group 1 - The core point of the article is that Chengdu Yuandong Biopharmaceutical Co., Ltd. has received a drug registration certificate from the National Medical Products Administration for its product "Elamomab Tablets" [1] Group 2 - Chengdu Yuandong Biopharmaceutical's wholly-owned subsidiary, Chengdu Shuo De Pharmaceutical Co., Ltd., is responsible for the newly approved product [1]

Core Viewpoint - Yuan Dong Biotech (688513.SH) has received approval from the National Medical Products Administration for its drug, Elamomab Tablets, which is indicated for active rheumatoid arthritis and is classified as a Category B drug in the 2024 National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog [1] Group 1 - The company’s wholly-owned subsidiary, Chengdu Shuo De Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Elamomab Tablets [1] - Elamomab, the active ingredient in the tablets, is specifically aimed at treating active rheumatoid arthritis [1] - The drug is included in the 2024 National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog as a Category B product [1]

Core Insights - The company announced that its wholly-owned subsidiary, Chengdu ShuoDe Pharmaceutical Co., Ltd., received the drug registration certificate for Elamomab tablets from the National Medical Products Administration [1] - Elamomab tablets are indicated for the treatment of active rheumatoid arthritis and are classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for 2024 [1] - The projected sales amount for Elamomab tablets in key public hospitals in major provinces and cities for 2024 is approximately 382 million yuan, representing a year-on-year growth of 12.90% [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]

Core Viewpoint - The collaboration between Xiansheng Pharmaceutical and NextCure aims to develop a novel antibody-drug conjugate (ADC) SIM0505 targeting the CDH6 antigen for solid tumors, with potential payments reaching up to $745 million [1][3]. Group 1: Collaboration Details - Xiansheng Pharmaceutical's subsidiary, Xiansheng Zaiming, will receive a maximum of $745 million in payments, including an upfront payment and milestone payments related to development and sales [1][3]. - NextCure will pay an upfront fee of $12 million, with additional payments contingent on financing events or by December 31, 2025 [3]. - Upon the initiation of the first Phase II clinical trial for SIM0505, NextCure will issue $1 million worth of common stock to Xiansheng, with the option to substitute cash [3]. Group 2: Market Context - Currently, there are no marketed drugs targeting CDH6 globally, although several companies are developing ADC products targeting this antigen, including DS-6000 and AMT-707 [3][4]. - The ADC SIM0505 is in Phase I clinical trials, with FDA approval expected in December 2024 and NMPA approval in January 2025 [4]. Group 3: Financial Implications - Xiansheng Pharmaceutical has achieved two overseas licensing agreements for self-developed innovative drugs this year, indicating a strategic shift towards external collaborations to boost revenue [4][10]. - The company has faced revenue stagnation, with total revenue remaining around 6 billion for three consecutive years, making these collaborations crucial for future growth [5][10]. - In 2024, the oncology segment generated revenue of 1.298 billion, accounting for 19.6% of total revenue, reflecting a 17.6% decline from 2023 [9].