Core Viewpoint - Tongrentang has received approval from the Canadian Ministry of Health for the product license of its product, Ma Ren Run Chang Wan, marking a significant milestone in its international expansion efforts [2] Company Summary - Tongrentang's subsidiary, Beijing Tongrentang Co., Ltd. Tongrentang Pharmaceutical Factory, has successfully obtained a Class III product license in Canada [2] - The approval indicates that Tongrentang is expanding its product registration in international markets, which may enhance its global presence and revenue potential [2]

Core Viewpoint - Tong Ren Tang's subsidiary, Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory, has received a Class III Product License from Health Canada for its product, Ma Ren Run Chang Wan, marking a significant step towards its market entry in Canada [1] Group 1 - The product Ma Ren Run Chang Wan has obtained the necessary product registration from Health Canada, which is essential for its commercialization in the Canadian market [1] - Following the product license approval, the company must complete additional regulatory requirements, including the certification of the production facility according to Canadian quality system standards [1]

Core Insights - The two major traditional Chinese medicine brands, Pian Zai Huang and Tong Ren Tang, are facing significant challenges, reflecting a broader struggle for traditional brands in the modern market [2][3] - Pian Zai Huang's price has dropped from 1600 yuan in 2021 to 650 yuan by Q3 2025, marking a significant decline in its market value [2] - Tong Ren Tang reported a 12.8% year-on-year decline in net profit for the first three quarters of 2025, with a nearly 30% drop in Q3 alone [2] Group 1: Market Challenges - Both Pian Zai Huang and Tong Ren Tang are experiencing a "mid-life crisis," with their core products facing declining sales and market relevance [3] - The traditional positioning of Tong Ren Tang's flagship product, An Gong Niu Huang Wan, as a "stroke prevention miracle drug" has led to over-marketing and a subsequent correction in consumer perception [5][10] - The 2024 National Medical Insurance Directory has significantly narrowed the reimbursement scope for An Gong Niu Huang Wan, further impacting sales [5] Group 2: Brand and Consumer Dynamics - The generational shift in consumer demand is reshaping the traditional Chinese medicine market, with younger consumers favoring convenient and trendy health products [9] - Tong Ren Tang has failed to adapt its marketing strategy to appeal to younger consumers, leading to a disconnect between its products and the new generation's needs [9][10] - The complexity of Tong Ren Tang's brand structure, with multiple entities like Beijing, Nanjing, and Tianjin Tong Ren Tang, has created consumer confusion and diluted brand trust [10][11] Group 3: Innovation and R&D - The traditional Chinese medicine industry, including Tong Ren Tang, suffers from low R&D investment, with an average of only 2.96% of revenue allocated to R&D compared to 10.93% for chemical pharmaceutical companies [13] - Tong Ren Tang's R&D spending has remained low, focusing primarily on traditional products rather than innovative new offerings [13][15] - The company has not identified new growth avenues, relying heavily on its historical brand strength rather than adapting to market changes [13][18]

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、准确性和完整性承担法律责任。 北京同仁堂股份有限公司（以下简称公司）分支机构北京同仁堂股份有限公 司同仁堂制药厂（以下简称同仁堂制药厂）收到加拿大卫生部核准签发的《产品 许可证（三类）》，同仁堂制药厂产品麻仁润肠丸获得加拿大产品注册。现将有关 情况公告如下： | 产品 | 品种批准文 | 剂型 | 适应症 | 持证商 | 持证商地址 | | --- | --- | --- | --- | --- | --- | | 名称 | 号（NPN） | | | 名称 | | | | | | 1.传统中医理论的药 | 北京同 | 北京市大兴区 | | | | | 物/产品制剂。 | 仁堂股 | | | 麻仁 | | | 2.用于缓解肠胃积热 | | 中关村科技园 | | | | | | 份有限 | | | 润肠 | 80143059 | 丸剂 | 引起的胸腹胀满，大便 | | 区大兴生物医 | | | | | | 公司同 | | | 丸 | | | 秘结。 | | 药产业基地天 | | | | | | 仁堂制 | 号 | ...

Core Viewpoint - Tong Ren Tang (600085.SH) has received a Class III product license from the Canadian Ministry of Health for its product, Ma Ren Run Chang Wan, indicating a significant step towards market entry in Canada [1] Group 1: Product Approval - The product Ma Ren Run Chang Wan is approved for use based on traditional Chinese medicine theories [1] - It is indicated for alleviating symptoms such as abdominal distension and constipation caused by gastrointestinal heat accumulation [1] - The approval represents a product market license, but further administrative approvals are required for sales in Canada, including certification of the production facility under Canadian quality standards [1]

Core Viewpoint - Tongrentang (600085.SH) has received a product license from the Canadian Ministry of Health for its product, Ma Ren Run Chang Wan, indicating a step towards potential market entry in Canada [1] Group 1: Regulatory Approval - The product license granted is categorized as a Class III product license, which is significant for the company's expansion plans [1] - The approval allows Tongrentang Pharmaceutical Factory to register its product in Canada, although further administrative approvals are required for market sales [1] Group 2: Impact on Financial Performance - The company stated that this approval will not have a significant impact on its recent operating performance [1]

Core Viewpoint - Tong Ren Tang (600085.SH) has received approval from Health Canada for its product, Ma Ren Run Chang Wan, which is now registered for use in Canada as a traditional Chinese medicine for alleviating gastrointestinal issues [1] Company Summary - The product Ma Ren Run Chang Wan is indicated for relieving symptoms such as abdominal distension and constipation caused by gastrointestinal heat accumulation [1] - The approval marks a significant step for Tong Ren Tang in expanding its market presence in Canada, highlighting the growing acceptance of traditional Chinese medicine in Western markets [1] Industry Summary - The registration of traditional Chinese medicine products in international markets reflects a broader trend of increasing globalization and acceptance of alternative medicine practices [1] - This development may open up further opportunities for similar products within the industry, potentially leading to increased sales and market growth [1]

Core Viewpoint - Tong Ren Tang (600085.SH) has received approval from the Canadian Ministry of Health for its product license, allowing the registration of its product, Ma Ren Run Chang Wan, in Canada, which is based on traditional Chinese medicine principles [1] Group 1 - The product Ma Ren Run Chang Wan is indicated for alleviating symptoms such as abdominal distension and constipation caused by gastrointestinal heat accumulation [1] - The approval signifies a significant step for the company in expanding its market presence in Canada [1] - The product is categorized under traditional Chinese medicine for promoting bowel movements [1]

Core Viewpoint - Tong Ren Tang (600085.SH) has received approval from the Canadian Ministry of Health for its product, Ma Ren Run Chang Wan, which is now registered for sale in Canada [1] Group 1: Product Approval - The product Ma Ren Run Chang Wan has been granted a Class III Product License by the Canadian Ministry of Health [1] - The indications for the product include traditional Chinese medicine formulations, relief from gastrointestinal heat leading to abdominal distension and constipation, and traditional herbal use for promoting bowel movements [1] Group 2: Regulatory Requirements - For the product to be sold in Canada, the company must complete additional administrative approvals, including but not limited to the Canadian production quality system certification for the manufacturing site [1] - There may be certain uncertainties associated with these regulatory approvals as per Canadian Ministry of Health requirements [1]

Core Viewpoint - Tong Ren Tang has received a product license from Health Canada for its product, Ma Ren Run Chang Wan, indicating a step towards international market expansion, although further approvals are required before it can be marketed [1] Group 1: Product Approval - The product Ma Ren Run Chang Wan has obtained a Class III product license from Health Canada, allowing it to be registered in Canada [1] - The approval signifies a potential entry into the Canadian market, which could enhance the company's international presence [1] Group 2: Future Steps and Uncertainties - Despite the product license, the company must still complete the Canadian production quality system certification for its manufacturing site, which introduces uncertainty regarding the timeline for market entry [1] - The impact of this approval on the company's recent financial performance is expected to be minimal [1] Group 3: Market Considerations - The success of the product in international markets may be influenced by various factors, including regulatory policies, market promotion efforts, customer acceptance, and competition [1]