Investment Rating - The report assigns a "Buy" rating for the company, indicating a positive outlook for its stock performance [5][7]. Core Views - The company is positioned as a leading player in the heparin raw material market, with a strong potential for growth in its API business due to improving market conditions [3][4]. - The company is focusing on its sterile injection formulations, which are experiencing rapid growth in overseas markets, supported by a robust product matrix and strategic acquisitions [4][61]. - The global biosimilar market is expected to expand significantly, and the company is well-positioned to capitalize on this trend through both self-developed products and strategic partnerships [5][67]. Summary by Sections 1. Company Overview - The company has transitioned from a traditional heparin raw material supplier to a high-end injection formulation and biosimilar provider, covering multiple therapeutic areas [13][16]. 2. Heparin API Market Improvement - The heparin raw material market is showing signs of recovery, with expectations for price stabilization and potential revenue growth for the company [3][31]. - The company has a strong production and sales level in its heparin API business, which is crucial for funding its injection formulation expansion [36][37]. 3. Focus on Sterile Injection Formulations - The company's injection business has seen significant revenue growth, with a 12.8% increase in 2023 and a compound annual growth rate (CAGR) of 47.4% from 2018 to 2023 [41][46]. - The company has a diverse product line in the injection segment, including low molecular weight heparin and anti-tumor agents, with a strong competitive position in the domestic market [47][55]. 4. Biosimilar Drug Development - The global biosimilar market is projected to grow rapidly, with the company actively developing multiple biosimilar products and securing market entry through strategic acquisitions [67][72]. - The company has made significant progress in obtaining FDA approvals for its biosimilar products, positioning itself as a key player in the U.S. market [72][73]. 5. Financial Projections - The company is expected to achieve substantial profit growth, with projected net profits of 9.0 billion, 11.9 billion, and 15.4 billion yuan for 2024, 2025, and 2026, respectively [5][6].

Investment Rating - The report initiates coverage with a "Strong Buy" investment rating for the company [4][8]. Core Insights - The company has a differentiated innovation pipeline with global competitiveness, showing potential to challenge current treatment standards [8][10]. - The globalization of the company is in a substantial development phase, with biosimilars continuing to expand internationally [8][10]. Financial Data and Valuation - The company’s total revenue is projected to grow from 3,215 million RMB in 2022 to 6,469 million RMB in 2026, with a compound annual growth rate (CAGR) of approximately 6% [3]. - The net profit attributable to shareholders is expected to increase from a loss of 695 million RMB in 2022 to a profit of 863 million RMB in 2026, reflecting a significant turnaround [3]. - The earnings per share (EPS) is forecasted to rise from -1.28 RMB in 2022 to 1.59 RMB in 2026, indicating strong growth potential [3]. Product Pipeline - HLX10 (PD-1 monoclonal antibody) shows significant improvement in overall survival for first-line metastatic colorectal cancer (mCRC) patients, with median progression-free survival (mPFS) of 16.8 months compared to 10.7 months for the current standard treatment [22][24]. - HLX22 (HER2 monoclonal antibody) has the potential to change the current first-line treatment for gastric cancer, with clinical studies indicating improved survival rates and manageable safety profiles [26][29]. - HLX43 (PD-L1 ADC) demonstrates excellent preclinical data and is positioned well in the competitive landscape for similar targets [2][10]. Globalization and Market Expansion - The company has successfully launched several biosimilars in over 40 countries, including the U.S. and EU, and is on track to introduce additional products like HLX11 (biosimilar to Pertuzumab) and HLX14 (biosimilar to Denosumab) in international markets [8][10]. - The company’s major shareholder, Fosun Pharma, provides a strong backing, enhancing its market position and operational capabilities [16][10].

关于全资子公司获得药品补充申请批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 证券代码：000963 证券简称：华东医药 公告编号：2025-013 华东医药股份有限公司 上市许可持有人：杭州中美华东制药有限公司 生产企业：江苏赛孚士生物技术有限公司 审批结论：根据《中华人民共和国药品管理法》及有关规定，经 审查，本品此次申请事项符合药品注册的有关要求，批准本品增加 "儿童斑块状银屑病。本品适用于对其他系统性治疗或光疗应答不足 或无法耐受的6岁及以上儿童和青少年（体重60公斤至100公斤）中重 度斑块状银屑病患者。"的补充申请，并修订说明书有关内容，说明 书按附件执行。 二、该药物研发及注册情况 HDM3001（QX001S）是原研产品Stelara®（喜达诺®，乌司奴单 抗注射液）的生物类似药，作用机理为阻断IL-12和IL-23共有的p40 亚基与靶细胞表面的IL-12Rβ1受体蛋白的结合，从而抑制IL-12和IL- 23介导的信号传导和细胞因子级联反应。IL-12和IL-23是两种天然存 在的细胞因子，在免疫介导的炎症性疾病中发挥着关键 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [9]. Core Insights - The company is positioned as an innovative biopharmaceutical enterprise with a comprehensive industry chain layout, focusing on ADCs, antibodies, and recombinant protein drugs, primarily targeting oncology and age-related diseases [5][17]. - The ADC technology platform is advanced, with the Nectin-4 ADC expected to become a best-in-class (BIC) product, showing promising clinical results compared to existing therapies [6][9]. - The company has a robust pipeline of innovative drugs and biosimilars, with significant revenue growth projected from 2024 to 2026 [8][10]. Summary by Sections Company Overview - The company was established in 2017 and went public on the Shanghai Stock Exchange in 2022, focusing on the research, production, and sales of biopharmaceuticals [17]. - It has 16 products at various stages, including 12 innovative products and 4 biosimilars, with 3 products already on the market [17]. ADC Technology Platform - The company has developed a next-generation ADC targeted conjugation technology platform (IDDCTM), which includes proprietary technologies that enhance drug stability and efficacy [6][28]. - The Nectin-4 ADC (9MW2821) is the fastest progressing ADC in China for treating urothelial carcinoma, currently in Phase III clinical trials [6][9]. Innovative Product Pipeline - The company is advancing multiple differentiated targets, including 9MW1911 (for COPD) and 9MW3011 (for blood disorders), with significant global development progress [7][30]. - The biosimilars have begun commercializing, contributing to cash flow for innovative drug development [7][30]. Financial Projections - Revenue forecasts for 2024, 2025, and 2026 are projected at 2.09 billion, 8.51 billion, and 15.14 billion RMB, respectively, with significant year-on-year growth rates [8][10]. - The company expects to achieve a net profit margin improvement, with net losses decreasing from 1.09 billion RMB in 2024 to 258 million RMB in 2026 [10].

H药目前已在欧洲、东南亚和中国等30多个国家获批上市。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，复宏汉霖（2696.HK）于近日公布了产品最新进展。2月5日，公司宣布，H药汉 斯状（斯鲁利单抗，欧洲商品名：Hetronifly）获欧盟委员会（EC）批准上市，用于联合卡铂和依 托泊苷用于广泛期小细胞肺癌（ES-SCLC）成人患者的一线治疗，H药成为了首个且唯一在欧盟获 批上市用于ES-SCLC治疗的抗PD-1单抗。截至目前，H药已在欧洲、东南亚和中国等30多个国家 获批上市，惠及超过90,000位患者。 此外，公司在研的Perjeta（帕妥珠单抗）生物类似药HLX11的生物制品许可申请（BLA）也于近日 获FDA受理。目前Perjeta已在多个国家和地区获批，适应症包括联合曲妥珠单抗和化疗用于HER2 阳性、局部晚期、炎性或早期乳腺癌患者的新辅助治疗，以及部分HER2阳性早期乳腺癌患者的辅助 治疗等。 迄今为止，复宏汉霖已有已有6款产品在中国获批上市，4款产品在国际获批上市，4个上市申请分别 获中国药监局、美国FDA和欧盟EMA受理。 突破差异化临床需求，H ...

Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） 香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 B. 申報背景及依據 自願公告 帕妥珠單抗生物類似藥HLX11 （重組抗HER2結構域II人源化單克隆抗體注射液） 的生物製品許可申請(BLA)獲美國食品藥品管理局(FDA)受理 A. 緒言 本公告由上海復宏漢霖生物技術股份有限公司（「本公司」）自願作出，以告知 本公司股東及潛在投資者本公司最新業務更新。 本公司董事會（「董事會」）欣然宣佈，近日，本公司自主研發的Perjeta® （帕 妥珠單抗）生物類似藥候選藥HLX11（重組抗HER2結構域II人源化單克隆抗 體注射液）（「HLX11」）的生物製品許可申請（「BLA」）獲美國食品藥品管理 局（「FDA」）受理，本次申請涉及的適應症如下：與曲妥珠單抗和多西他賽 聯合，用於治療既往未接受過針對轉移性疾病抗HER2治療或 ...

有望为国内银屑病患者提供更可负担的用药选择。 本文为IPO早知道原创 作者｜罗宾 微信公众号｜ipozaozhidao 据IPO早知道消息，11月5日，华东医药（000963.SZ）发布公告，其下属杭州中美华东制药有限公 司（下称"中美华东"）收到国家药监局（NMPA）核准签发的《药品注册证书》，由中美华东与荃 信生物（2509.HK）联合开发的乌司奴单抗注射液赛乐信（研发代码：HDM3001/QX001S）的上 市许可申请获得批准，用于治疗成年中重度斑块状银屑病，成为国内首个乌司奴单抗注射液生物类似 药。 赛乐信是原研产品Stelara（喜达诺，乌司奴单抗注射液）的生物类似药，为一款白介素IL-12/23 单抗药物。据强生公司2023年报，2023年Stelara在全球的销售额为108.58亿美元（约767.29亿 元人民币）。米内网数据显示，2023年喜达诺在中国的销售额为13.22亿元人民币。 此次赛乐信获批上市，有望为国内银屑病患者带来更可负担的用药选择。 本文由公众号IPO早知道（ID：ipozaozhidao）原创撰写，如需转载请联系C叔↓↓↓ QX001S最初由荃信生物自主研发，2020年8月， ...