投资者越来越意识到，环境、社会和治理（ESG）表现优异的企业往往在创新能力、长期韧性等方面更具优势，更能适应复杂多变的全球环境，从而创造更 稳定、可持续的投资回报。 在此背景下，近期在格隆汇·中期策略峰会上，四环医药荣获"格隆汇金格奖·ESG创新实践卓越企业"。该奖项不仅是对其长期可持续发展实践的肯定，更是 对其在高增长医美与创新驱动生物制药领域所取得成就及其社会价值的认可。 活动当天，四环医药亦与投资者进行了深入交流。不妨借此了解，公司究竟是如何在ESG浪潮下把握未来医美与创新药行业的机遇。 1、医美业务高增长，绿色创新与普惠可及共筑ESG内核 依托"自研+BD"策略，四环医药旗下医美平台渼颜空间已布局覆盖填充、塑形、光电设备及皮肤管理等60余款产品，满足全生命周期需求，并取得爆发式增 长，2024年医美业务收入达7.44亿元，同比增长65.4%。 支撑这一亮眼业绩的，是公司对产品创新合规以及渠道深化的持续投入。 一方面，四环医药以制药企业的严谨态度打造医美产品矩阵。 全球ESG投资正加速向主流化迈进。 今年上半年，公司自主研发的注射用聚己内酯微球面部填充剂（"少女针"）和聚乳酸面部填充剂（"童颜针"）相继 ...

格隆汇6月9日丨四环医药(00460.HK)宣布，集团旗下非全资附属公司轩竹生物自主研发的1类创新药吡 洛西利片(商品名：轩悦宁®)新增适应症的新药上市申请("NDA")获得中国国家药品监督管理局 ("NMPA")受理，具体适应症为：与芳香化酶抑制剂联用作为激素受体阳性(HR+)、人表皮生长因数受体 2阴性(HER2-)("HR+/HER2-")晚期乳腺癌患者的初始内分泌治疗，以及经他莫昔芬或托瑞米芬辅助治疗 后进展患者的后续治疗。是该产品申报NDA的第3项适应症。 吡洛西利是轩竹生物自主研发的一款CDK4/6(细胞周期依赖性激酶4和6)抑制剂，凭藉其独特的 CDK2/4/6/9多靶点协同作用机制，在强效抑制肿瘤细胞增殖的同时，显着降低传统CDK4/6抑制剂常见 的3/4级中性粒细胞减少等血液学毒性，提升患者治疗耐受性。此前已获批联合氟维司群二线内分泌治 疗及单药后线治疗两大适应症，未来该产品将覆盖HR+/HER2-晚期乳腺癌患者的一线、二线、后线治 疗的全部人群，将进一步完善乳腺癌全程管理布局，为国内患者提供更精准的治疗选择。 吡洛西利此次新适应症NDA获受理，不仅是本集团创新研发实力的有力证明，也意味着我 ...

Core Viewpoint - The stock performance of pharmaceutical companies, particularly SiHuan Pharmaceutical, has been notably strong following the approval of its innovative drug, Pyrotinib tablets, for treating advanced breast cancer [1][3][4]. Company Overview - SiHuan Pharmaceutical operates in various segments including aesthetic medicine, innovative drugs, and generic drugs, with a focus on multiple therapeutic areas such as diabetes, oncology, and digestive diseases [3]. - The company has developed over 60 aesthetic medicine products and more than 40 innovative and biological drug pipelines [3]. Recent Developments - On May 15, SiHuan Pharmaceutical announced that its subsidiary, XuanZhu Biotechnology, received approval from the National Medical Products Administration of China for its innovative drug Pyrotinib tablets for two indications related to HR+/HER2- advanced breast cancer [3][4]. - Pyrotinib is the only approved CDK4/6 inhibitor in China for this specific indication, marking a significant milestone for XuanZhu Biotechnology [4]. Market Context - Breast cancer is the most common malignancy among women globally, with an estimated 2.3 million new cases in 2022, projected to rise to 3.2 million by 2050 [5]. - Approximately 70% of breast cancer patients are HR+ subtype, indicating a substantial treatment demand [5]. - The global sales of CDK4/6 inhibitors exceeded $10 billion in 2023, with China's sales reaching approximately RMB 2.2 billion, expected to grow to RMB 13 billion by 2032 [5]. Financial Performance - SiHuan Pharmaceutical has faced declining performance in recent years, with revenues of RMB 2.181 billion in 2022, projected to be RMB 1.861 billion in 2023 and RMB 1.901 billion in 2024 [8]. - The company reported significant losses, with shareholder profits of -RMB 1.915 billion in 2022 and -RMB 0.54 billion in 2023 [8]. - The generic drug segment saw a revenue decline of approximately 21.4% in 2024, while the aesthetic medicine segment grew by about 65.4% [9]. Future Outlook - The approval of Pyrotinib is expected to positively impact SiHuan Pharmaceutical's financial performance, although the extent of this impact remains to be seen [10]. - The aesthetic medicine segment shows promising growth and could significantly contribute to the company's overall performance moving forward [10].

华泰证券指出，往前看，美国对华关税水平低于市场预期，出口链压力减弱下中国增长预期或抬升，尤 其是在此前并未跟随其他货币升值的情况下，人民币及人民币资产均有补涨空间。历史上看，人民币走 势与港股收益相关性较强。人民币走强能够同时改善香港贸易条件，并且提升整体人民币资产吸引力。 依然看好港股相对全球市场的收益表现。 智通财经APP获悉，港股早盘承压低开后下挫，恒科指曾跌超2%，随即跌幅收窄，恒指及国指午后一 度翻红，最终均小幅收跌。但截止收盘，恒生指数跌0.05%或12.33点，报23332.72点，大市交投进一步 缩减，全日成交额为1847.04亿港元；恒生国企指数跌0.09%，报8460.55点；恒生科技指数跌0.5%，报 5255.06点。 蓝筹股表现 小米集团-W(01810)由跌转涨。截至收盘，涨2.65%，报52.35港元，成交额110.97亿港元，贡献恒指 39.24点。小米汽车官方微博宣布，将于5月22日19点举行小米战略新品发布会。小米SUV车型YU7，自 研手机SoC芯片玄戒O1和小米15SPro旗舰手机将于同日发布。此外，小米集团董事长雷军微博发文表 示，小米玄戒O1，采用第二代3nm工艺制 ...

Group 1 - The Hang Seng Index fell by 0.49%, losing 114 points, while the Hang Seng Tech Index dropped by 1.03%, with a trading volume of 105.5 billion HKD in the morning session [1] - Nvidia's CEO Jensen Huang stated that the company is reassessing its strategy in the Chinese market due to U.S. government restrictions on the export of the Hopper architecture H20 chip to China, and will not launch the Hopper series chips in the future [1] - Semiconductor stocks rose against the market trend, with Hua Hong Semiconductor increasing over 4% and SMIC rising more than 1.8% [1] Group 2 - Fubo Group saw an increase of over 4% following the release of the "Digital China Construction 2025 Action Plan," which aligns with the company's AI service layout [2] - Four Seasons Pharmaceutical surged over 16% after receiving drug registration approval for two indications of its Pyrotinib tablets [3] - Xiansheng Pharmaceutical rose over 7% as the resurgence of COVID-19 raised attention, with its product Xianoxin being the first oral COVID-19 drug in China to receive regular approval [4] Group 3 - CanSino Biologics saw an increase of over 6% after collaborating with CSPC to develop KN026, which has reached the primary endpoint of the PFS [5] - Giant Legend surged over 12% as the show "Travel Diary 3" gained popularity, leading to the company's IP business revenue surpassing its new retail business for the first time [5] - Guming increased over 3% after being included in the Hang Seng Composite Index, with CICC optimistic about its same-store sales growth maintaining a high year-on-year level in Q2 [6] Group 4 - Aimee Vaccine rose over 9% as both the U.S. and China approved clinical trials for the iterative mRNA shingles vaccine [7] - Apple-related stocks collectively declined, with notable drops including Highgreat Electronics down 3.89%, Sunny Optical down 3.95%, and BYD Electronics down 1.7% [7] - Alibaba's stock continued to fall over 4% after its fourth fiscal quarter revenue fell short of expectations, and reports indicated that its AI collaboration plan with Apple is under U.S. review [8]

证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 三抗药物研发进入快车道，建议关注泽璟制 药、三生制药等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 ◼ 全球首个:艾伯维 c-Met ADC 获批上市；百济神州启动 BGB-16673 vs Pirtobrutinib 头对头 I 期研究：5 月 14 日，艾伯维宣布 FDA 已批准 c- Met 靶向 ADC 药物 telisotuzumab vedotin（Teliso-V，ABBV-399）的生 物制品许可申请（BLA），用于治疗既往接受过治疗的 c-Met 蛋白过表 达、表皮生长因子受体（EGFR）野生型晚期/转移性非鳞状非小细胞肺 癌（NSCLC）成人患者。该药物是 c-Met 赛道首款获批上市的 ADC 产 品，也是艾伯维首款自研 ADC 产品。5 月 15 日，全球临床试验收录网 站 显 示 ， 百 济 神 州 启 动 了 BGB-16673 （ catadegbrutinib ） 头 对 头 Pirtobrutinib（匹妥布替尼）的 III 期临床试验（CaDAnCe-304）。 ◼ 具体配置建议 ...

证券研究报告·行业跟踪周报·医药生物 医药生物行业跟踪周报 2025 年 05 月 18 日 证券分析师 朱国广 执业证书：S0600520070004 zhugg@dwzq.com.cn 三抗药物研发进入快车道，建议关注泽璟制 药、三生制药等 增持（维持） [Table_Tag] [Table_Summary] 投资要点 ◼ 全球首个:艾伯维 c-Met ADC 获批上市；百济神州启动 BGB-16673 vs Pirtobrutinib 头对头 I 期研究：5 月 14 日，艾伯维宣布 FDA 已批准 c- Met 靶向 ADC 药物 telisotuzumab vedotin（Teliso-V，ABBV-399）的生 物制品许可申请（BLA），用于治疗既往接受过治疗的 c-Met 蛋白过表 达、表皮生长因子受体（EGFR）野生型晚期/转移性非鳞状非小细胞肺 癌（NSCLC）成人患者。该药物是 c-Met 赛道首款获批上市的 ADC 产 品，也是艾伯维首款自研 ADC 产品。5 月 15 日，全球临床试验收录网 站 显 示 ， 百 济 神 州 启 动 了 BGB-16673 （ catadegbrutin ...

乳腺癌治疗领域迎来一大重磅消息。 近日，四环医药旗下轩竹生物自主研发的吡洛西利片（商品名：轩悦宁）获批乳腺癌单药及联合氟维司 群双适应症，成为国内唯一拥有单药适应症的CDK4/6抑制剂。 这不仅直接填补了国产创新药在这一领域的临床空白，更标志着我国乳腺癌靶向治疗进入"中国方案"新 阶段。 1、精准匹配中国患者特征，亮眼临床数据破局乳腺癌精准治疗 乳腺癌作为威胁全球女性健康的"头号杀手"，吡洛西利通过独特的"CDK2/4/6/9四靶点作用"机制，在精 准阻断肿瘤细胞增殖通路的同时，能够显著降低血液学毒性发生率，实现对肿瘤的强效持续抑制并提升 治疗耐受性。 这一突破性设计的战略意义，在中国乳腺癌患者中体现的更为深刻。原因在于，我国乳腺癌患者具有中 位发病年龄较西方国家更早、Luminal B型肿瘤、原发耐药及化疗人群比例更高、预后相对较差等特 征，传统治疗方案往往"力不从心"。 从多靶点机制创新到精准匹配中国临床需求的试验设计，吡洛西利的成功上市及其全球领先的疗效数 据，充分彰显了轩竹生物以临床价值为导向的创新研发体系，以及解决重大未满足医疗需求的硬核科技 实力。 2、"医美+创新药"双轮驱动，四环医药基本面全线 ...

Group 1 - The core point of the news is that Shiyao Group has signed an exclusive licensing agreement with Cipla USA, Inc. for the commercialization of Irinotecan liposome injection in the U.S., indicating significant commercial potential in the U.S. market [1] - The agreement includes an upfront payment of $15 million, potential milestone payments of up to $25 million for initial commercial sales and regulatory milestones, and up to $1.025 billion in additional commercial sales milestone payments, along with double-digit sales royalties based on annual net sales in the region [1] - This partnership represents a major breakthrough in the company's international strategy, enhancing its global market influence and investor confidence in future profitability [1] Group 2 - The first enzyme replacement therapy for Gaucher disease in China, β-CAN103, has been approved for long-term treatment in adolescents and adults aged 12 and above, filling a gap in the rare disease treatment field [2] - The therapy specifically supplements the enzyme glucocerebrosidase that is deficient in Gaucher disease patients, showcasing the company's research capabilities in rare diseases [2] - The market entry of β-CAN103 is expected to provide a new growth point for the company and enhance its competitiveness and market value in the biopharmaceutical sector [2] Group 3 - Xuanzhu Bio's CDK4/6 inhibitor, Pyrotinib tablets, have received approval for two indications, targeting HR+/HER2- advanced or metastatic breast cancer patients who have progressed after prior endocrine therapy and chemotherapy [3] - This approval marks a significant breakthrough in the company's oncology treatment portfolio, indicating substantial market potential [3] - The new drug approval is anticipated to enhance the company's competitiveness in innovative drugs and provide new performance growth points, boosting investor confidence in its research capabilities and future development [3] Group 4 - WuXi AppTec has entered into a licensing agreement with its major shareholder, Juno, granting non-exclusive rights to develop and commercialize cell therapy products using the JW sLVV production process and related technologies [4] - The total consideration for this agreement is capped at $10 million, which includes non-refundable upfront payments and additional payments [4] - This move not only generates revenue for the company but also strengthens its collaboration with a key shareholder, enhancing investor confidence in its future development [4] Group 5 - Hainan Haiyao has signed a strategic cooperation framework agreement with Malaysia's Aikang International Group, becoming the exclusive agent for Aikang's health products in China [6] - The company will be responsible for promoting, selling, and providing after-sales service for Aikang's high-quality health products in the Chinese market [6] - This partnership is a significant step in expanding the company's business footprint in the health sector, potentially increasing market share and profitability while enhancing investor confidence in its growth potential [6]

Core Viewpoint - The approval of the new drug Pyrocilin (XZP-3287) by the National Medical Products Administration of China marks a significant advancement for the company and provides a new treatment option for patients with HR+/HER2- advanced breast cancer [1][2]. Group 1: Drug Approval and Indications - The new drug application (NDA) for Pyrocilin has been granted for two indications: (1) as a monotherapy for adult patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after two or more endocrine therapies and one chemotherapy; (2) in combination with Fulvestrant for adult patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after endocrine therapy [1]. - Pyrocilin is the only CDK4/6 inhibitor approved in China for monotherapy in HR+/HER2- advanced breast cancer after prior lines of treatment [2]. Group 2: Clinical Trial Data and Efficacy - Clinical trial data indicates that the median age of breast cancer patients in China is younger than in Western countries, with a higher proportion of Luminal B type tumors, primary resistance, and chemotherapy patients, leading to poorer prognosis [2]. - In the clinical study, 23.9% of patients had previously received late-stage chemotherapy, 25.6% were primary resistant, 37% were premenopausal, and 68.2% had visceral metastases [2]. - The median progression-free survival (mPFS) for patients receiving Pyrocilin in combination with Fulvestrant reached 14.7 months (investigator assessment) and 17.5 months (BIRC assessment), while the mPFS for monotherapy reached 11 months, setting a new record for similar therapies globally [2]. Group 3: Company Strategy and Future Outlook - The approval of Pyrocilin is a strong testament to the company's innovative research and development capabilities and represents a significant step towards providing effective treatment options for breast cancer patients [2]. - The company plans to continue its innovation-driven development strategy, increasing research and development investment, and accelerating the translation of innovative results to contribute more to global health [2].