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。 证券代码：688198 证券简称：佰仁医疗 公告编号：2025-037 北京佰仁医疗科技股份有限公司 关于自愿披露子公司胶原蛋白植入剂产品获批注册的公 告 司平台化运营的优势。 该胶原蛋白植入剂上市后实际销售情况受市场推广效果、市场竞争环境变化等 影响，具有不确定性，目前尚无法预测上述产品对公司未来营业收入的影响，敬请 投资者注意投资风险。 特此公告。 北京佰仁医疗科技股份有限公司董事会 2025年12月12日 近日，经国家药品监督管理局审评，北京佰仁医疗科技股份有限公司（以下简 称"公司"）的控股子公司北京艾佰瑞生物技术有限公司胶原蛋白植入剂产品（即胶 原纤维填充剂-I）注册申请获得批准，这是国内首款用于面颊部真皮层注射以改善 面颊部平滑度的胶原蛋白产品，现将有关情况公告如下： 该产品为天然交联的完整I型胶原蛋白纤维（Collagen Fibrils & Fibers），具有 稳定的三股螺旋结构，并在此基础上自发组装成有序的纤维状超分子结构，该产品 的植入可补充面颊部真皮层 ...

Core Viewpoint - The approval of the collagen implant product by the National Medical Products Administration marks a significant milestone for the company, being the first collagen product in China for dermal injection to improve cheek smoothness [1][2]. Group 1: Product Details - The product is a natural cross-linked complete type I collagen fiber, featuring a stable triple helix structure that self-assembles into an ordered fibrous supramolecular structure [1]. - The implantation of this product can supplement the collagen framework in the dermis of the cheeks, improving extracellular matrix metabolism and enhancing skin texture and elasticity [1]. - The innovative technology includes a proprietary ultra-pure extraction process and precise peptide cleavage, ensuring the amino acid sequence and composition are consistent with human type I collagen at the molecular level [1]. Group 2: Technological and Developmental Implications - The core technology of the product stems from the company's years of expertise in the collagen field, laying the groundwork for future products such as type II and type III collagen [2]. - The successful launch of this product represents a milestone achievement for the company's original research and innovation platform in animal-derived implant materials, showcasing the advantages of the company's platform-based operations [2].

Core Viewpoint - The announcement by Baijun Medical (688198) regarding the approval of its collagen implant product marks a significant milestone in the domestic market for aesthetic medical products, specifically for facial treatments [1] Company Summary - Baijun Medical's subsidiary, Beijing Aibairui Biotechnology Co., Ltd., has received approval from the National Medical Products Administration for its collagen fiber filler product, which is the first of its kind in China for injection into the dermal layer of the cheeks to improve smoothness [1]

Market Overview - The Shanghai Composite Index is at 3884.77 points, above the six-month moving average, with a decline of 0.63% [1] - The total trading volume of A-shares is 843.164 billion yuan [1] Stocks Breaking the Six-Month Moving Average - A total of 59 A-shares have surpassed the six-month moving average today [1] - Notable stocks with significant deviation rates include: - Yonghui Supermarket (601933) with a deviation rate of 9.65%, closing at 5.23 yuan [1] - Huijia Times (603101) with a deviation rate of 9.51%, closing at 10.59 yuan [1] - Jinchuan Group (603680) with a deviation rate of 9.01%, closing at 13.12 yuan [1] Additional Stocks with Deviation Rates - Other stocks with notable performance include: - Kaide Stone (920179) with a 13.74% increase and a deviation rate of 8.62% [1] - Wuzhou Medical (301234) with a 9.22% increase and a deviation rate of 6.99% [1] - Bubu Gao (002251) with a 9.94% increase and a deviation rate of 6.83% [1] Stocks with Smaller Deviation Rates - Stocks with smaller deviation rates that have just crossed the six-month moving average include: - Guodian Nari (601366) with a deviation rate of 1.80% [1] - Zhenhua Technology (603527) with a deviation rate of 1.69% [1] - ST Sansheng (002742) with a deviation rate of 0.92% [2]

Core Viewpoint - The medical device sector experienced a slight decline of 0.23% on December 8, with BaiRen Medical leading the losses, while the overall market indices showed positive performance with the Shanghai Composite Index rising by 0.54% and the Shenzhen Component Index increasing by 1.39% [1] Group 1: Market Performance - The medical device sector's decline was led by BaiRen Medical, which saw a drop of 3.39% in its closing price [2] - The Shanghai Composite Index closed at 3924.08, up 0.54%, while the Shenzhen Component Index closed at 13329.99, up 1.39% [1] Group 2: Individual Stock Performance - ZhenDe Medical (603301) had a closing price of 74.01, with a significant increase of 6.95% and a trading volume of 178,200 shares, amounting to a transaction value of 1.317 billion yuan [1] - Other notable gainers included Rejing Bio (688068) with a closing price of 181.00, up 4.89%, and Huakang Clean (301235) at 31.03, up 4.76% [1] - BaiRen Medical (688188) closed at 111.99, down 3.39%, with a trading volume of 9,959.93 shares and a transaction value of 113 million yuan [2] Group 3: Capital Flow - The medical device sector saw a net outflow of 199 million yuan from institutional investors, while retail investors contributed a net inflow of 213 million yuan [2] - The capital flow data indicates that ZhenDe Medical had a net inflow of 210 million yuan from institutional investors, while retail investors showed a net outflow of 169 million yuan [3]

Group 1 - Dongfang Electric announced that three executives plan to reduce their holdings by a total of no more than 30,000 shares due to personal financial needs [1] - Yahu Pharmaceutical's APL-1401 clinical trial data was presented at the 19th European Colorectal Congress, indicating progress in treating moderate to severe ulcerative colitis [1] - Guizhou Bai Ling's actual controller is under investigation by the China Securities Regulatory Commission for insider trading and information disclosure violations [3] Group 2 - Bairen Medical's ePTFE pericardial membrane product has been approved for registration, ending the reliance on imports for this product in the domestic market [4] - Qianxin received approval for a total of 2 billion yuan in technology innovation bonds, with plans to issue medium-term notes and short-term financing bonds [6] - Tengjing Technology's shareholder plans to reduce holdings by no more than 1.96% of the company's shares [7] Group 3 - Yuntianhua's subsidiary is required to pay 386 million yuan in overdue taxes and penalties, which will impact the company's net profit for 2025 [8] - Jianyou Pharmaceutical's propofol emulsion injection has received FDA approval in the United States [9] - Suzhou Gaoxin successfully acquired land use rights for a residential project for 360 million yuan [9] Group 4 - Chalco International's subsidiary won a bid for a 3.03 billion yuan electrolytic aluminum project [11] - Tai Long Pharmaceutical's stock will continue to be suspended due to potential changes in control as the major shareholder is planning a share transfer [12] - Qianli Technology reported a 63.44% year-on-year increase in automobile sales for November, although new energy vehicle sales decreased by 43.98% [13] Group 5 - Fosun Pharma's innovative drug FXS0887 has received approval for a Phase I clinical trial for advanced malignant solid tumors [14] - Guoen Co. has obtained approval for a project to produce 20,000 square meters of aviation-grade acrylic glass, with a total investment of 560 million yuan [15] - Guofa Co.'s chairman resigned due to personal reasons [17] Group 6 - Shanghai Construction won a bid for a state-owned construction land use right for 264 million yuan [18] - Weixin Kang's subsidiary received approval for a clinical trial of lidocaine cream for local anesthesia [20] - Sanxing Medical's subsidiary is a candidate for a 152 million yuan transformer procurement project for the State Grid [20] Group 7 - People's Daily announced the resignation of its president due to work changes, while retaining other leadership roles [21] - Beibu Gulf Port reported a 0.29% year-on-year increase in cargo throughput for November [22] - Chongqing Construction won three engineering projects with a total value of approximately 2.773 billion yuan [23] Group 8 - Xingyu Co. is planning to issue H-shares and list on the Hong Kong Stock Exchange [24] - Huajian Group signed a design contract worth 160 million yuan for a comprehensive project [25] - Wankai New Materials plans to invest 350 million yuan in a technical transformation project for producing 100,000 tons of adipic acid [26] Group 9 - Kaipuyun received a government subsidy of 18 million yuan, which is 87.43% of its net profit for the last audited fiscal year [28] - Ningbo Port expects a 10.8% year-on-year increase in container throughput for November [30] - An Cai High-Tech plans to invest 498 million yuan to upgrade its photovoltaic glass production line [32] Group 10 - Shunhao Co. stated that its existing business has not generated synergies with the rail business, which faces various risks [34] - Yihualu plans to publicly transfer 35% of its stake in Liaoyun Company [35] - ST Wanfang's shareholder plans to reduce holdings by no more than 3% of the company's shares [36] Group 11 - Youyou Food's shareholder plans to reduce holdings by no more than 110,000 shares [38] - Hengtong Optic-Electric's incentive fund has spent 49.98 million yuan to purchase company shares [41] - Zoli Pharmaceutical plans to issue convertible bonds to raise no more than 1.556 billion yuan for various projects [42]

Core Viewpoint - The approval of the ePTFE membrane product by the National Medical Products Administration marks a significant development for Baijun Medical, as it ends the reliance on imported ePTFE membranes in the domestic market [1] Company Summary - Baijun Medical (688198) announced the approval of its ePTFE membrane product for registration, which is a 0.1mm expanded polytetrafluoroethylene membrane [1] - The product is intended for the repair or reconstruction of the pericardium in cardiac surgery [1] Industry Summary - The current market for pericardial membranes in China has been dominated by foreign companies, leading to a long-standing dependence on imports [1] - The registration and upcoming market entry of Baijun Medical's product will disrupt this import reliance, potentially transforming the domestic market landscape for cardiac surgical materials [1]

证券代码：688198 证券简称：佰仁医疗 公告编号：2025-036 北京佰仁医疗科技股份有限公司 关于自愿披露ePTFE心包膜产品获批注册的公告 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。 该产品为0.1mm的膨体聚四氟乙烯（ePTFE）膜，用于心脏外科手术中心包膜 的修复或重建。人体的心脏表面有一层薄膜包裹着整个心脏，这层薄膜被称为心包 或心包膜，对心脏表面组织，特别是对冠状动脉血管具有保护作用。每当需要进行 心外手术时，都不可避免地要切开心包膜，由于心包的外科损伤所致术后永久失去 原有心包膜，以致导致心脏表面裸露与胸骨组织粘连，使得再行开胸手术时面临出 血等严重并发症的风险，致使手术难度增加，特别是小儿复杂先心病患者，很多都 需要再次开胸。因此，开心手术常规需要植用心包膜（ePTFE）修复或重建破损心 包以保护心脏。目前国内市场所用的心包膜为外企垄断，长期以来依赖进口，该产 品的注册和上市将结束心外ePTFE心包膜依赖进口的历史。 基于庞大的治疗需求，国内心脏大血管外科手术量多年来保持持续增长，2024 年全国 ...

该产品为0.1mm的膨体聚四氟乙烯（ePTFE）膜，用于心脏外科手术中心包膜的修复或重建。人体的心 脏表面有一层薄膜包裹着整个心脏，这层薄膜被称为心包或心包膜，对心脏表面组织，特别是对冠状动 脉血管具有保护作用。每当需要进行心外手术时，都不可避免地要切开心包膜，由于心包的外科损伤所 致术后永久失去原有心包膜，以致导致心脏表面裸露与胸骨组织粘连，使得再行开胸手术时面临出血等 严重并发症的风险，致使手术难度增加，特别是小儿复杂先心病患者，很多都需要再次开胸。因此，开 心手术常规需要植用心包膜（ePTFE）修复或重建破损心包以保护心脏。目前国内市场所用的心包膜为 外企垄断，长期以来依赖进口，该产品的注册和上市将结束心外ePTFE心包膜依赖进口的历史。 格隆汇12月3日丨佰仁医疗(688198.SH)公布，近日，经国家药品监督管理局审查，公司研发的心包膜 （ePTFE）产品获批注册。 ...

Group 1 - The core point of the article is that Baijun Medical (688198.SH) has received approval from the National Medical Products Administration for its ePTFE product, which is used for the repair or reconstruction of the pericardium during cardiac surgeries [1] - The ePTFE membrane is 0.1mm thick and serves to protect the heart surface, particularly the coronary vessels, during surgical procedures [1] - The approval of this product will end the reliance on imported ePTFE pericardial membranes in the domestic market, which has been dominated by foreign companies for a long time [1] Group 2 - The pericardium is a thin membrane that envelops the heart, and surgical damage to it can lead to serious complications, especially in pediatric patients with complex congenital heart disease [1] - The need for ePTFE membranes in cardiac surgeries is critical, as they are routinely used to repair or reconstruct damaged pericardium to protect the heart [1] - The introduction of this product is expected to significantly impact the market by providing a domestic alternative to previously imported solutions [1]