Summary of Conference Call Company and Industry - The conference call involved a discussion about Hehua Pharmaceutical and its recent business developments, particularly focusing on the sale of non-core assets and advancements in their R&D pipeline. Key Points and Arguments Business Developments - Hehua Pharmaceutical has announced the sale of a 45% stake in Shanghai Hehuang, which is expected to generate over $608 million in proceeds, with an estimated gain of approximately $477 million [4][5][22]. - The company has been managing the asset for over 20 years, contributing significantly to cash flow [1][2]. R&D Focus - The company plans to focus more on innovation and the development of new drugs, particularly in accelerating clinical trials for innovative drugs globally [2][3]. - The ATTC platform is highlighted as a new technology that combines small molecule drugs with large antibodies, aiming to reduce toxicity and improve efficacy compared to traditional ADCs [6][7][9]. Financial Outlook - The company aims to ensure a 5% growth in net profit for the joint venture over the next three years, with a special shareholders' meeting planned for February to discuss the transaction [5][22]. - The cash generated from the sale will provide more room for strategic investments and R&D, while maintaining profitability targets [3][4][21]. Clinical Trials and Product Pipeline - Several products are expected to enter clinical trials in the second half of the year, with a focus on enhancing production capabilities for large molecules [3][10]. - The company has submitted NDA applications for new drugs, including a new treatment for lung cancer, and is optimistic about receiving approvals [12][32]. Strategic Partnerships - Collaboration with AstraZeneca is ongoing for international clinical trials, with a focus on expanding the product pipeline and enhancing global market presence [13][14][32]. Other Important Content - The company is committed to in-house R&D for the ATTC platform, avoiding reliance on CROs to maintain control over production processes [20][21]. - Future R&D investments are expected to increase gradually, aligning with clinical progress while ensuring profitability [21][22]. - The ATTC platform is positioned as a competitive and innovative approach in the biopharmaceutical landscape, with potential applications across various therapeutic areas [30][35]. This summary encapsulates the key discussions and insights from the conference call, highlighting the strategic direction and financial outlook of Hehua Pharmaceutical.

Investment Rating - The report maintains a "Buy" rating for Hutchison China MediTech (0013.HK) with a target price of HKD 40.90, while the current price is HKD 23.40 [1]. Core Insights - Hutchison China MediTech has announced the sale of a 45% stake in Shanghai Hutchison Pharmaceuticals for USD 608 million (RMB 4.478 billion) to focus on innovative drug development. The proceeds will be used to further develop its internal product pipeline, particularly its next-generation antibody-drug conjugate (ADC) platform [7]. - The NDA for Savolitinib in combination with Osimertinib for treating MET-amplified NSCLC has been accepted and prioritized for review in China, indicating significant progress in addressing resistance issues in EGFR inhibitors [7]. - The commercialization of Fuzuloparib in the U.S. has been successful, with expected sales of USD 130 million in the first half of 2024, and it has been included in healthcare insurance in Spain and Japan, enhancing its commercial prospects [7]. Financial Summary - Revenue projections for Hutchison China MediTech are USD 642.07 million in 2024, USD 736.97 million in 2025, and USD 884.99 million in 2026, reflecting a growth rate of -23.38%, 14.78%, and 20.09% respectively [2]. - The net profit attributable to the parent company is expected to be -USD 17.24 million in 2024, USD 74.51 million in 2025, and USD 134.20 million in 2026, with growth rates of -117.10%, 532.22%, and 80.12% respectively [2]. - The earnings per share (EPS) are projected to be -USD 0.02 in 2024, USD 0.09 in 2025, and USD 0.15 in 2026 [2].

Investment Rating - The report maintains a "Buy" rating for the company [9] Core Insights - The company announced that the NDA for the combination therapy of Savolitinib and Osimertinib for treating MET-amplified EGFR-mutant NSCLC has been accepted by the National Medical Products Administration and is under priority review [5] - The company plans to use the proceeds from the sale of its 45% stake in Shanghai Henlius Biotech for further development of its internal product pipeline, including a new generation ADC platform [5] - The estimated reasonable value of the company is HKD 41.35 per share, with projected net profits of USD 0.05 million, USD 0.20 million, and USD 0.74 million for the years 2024 to 2026 respectively [5] Financial Summary - Main revenue is projected to grow from USD 426 million in 2022 to USD 838 million in 2023, followed by a decline to USD 641 million in 2024 [3] - EBITDA is expected to improve from a loss of USD 361 million in 2022 to a profit of USD 78 million in 2023, with a forecasted loss of USD 7 million in 2024 [3] - The net profit attributable to shareholders is projected to turn from a loss of USD 361 million in 2022 to a profit of USD 101 million in 2023, and further to USD 5 million in 2024 [3] - The company’s EPS is expected to rise from -0.42 in 2022 to 0.12 in 2023, and reach 0.08 by 2026 [3] - The company’s ROE is projected to improve from -56.6% in 2022 to 13.6% in 2023, and reach 8.7% by 2026 [3]

Core Viewpoint - The new drug application for the combination therapy of Savolitinib and Osimertinib for treating MET amplified EGFR mutation-positive non-small cell lung cancer has been accepted and prioritized for review by the National Medical Products Administration of China [1] Group 1 - The combination therapy has shown potential to improve treatment continuity and quality of life for patients, with multiple late-stage clinical trials currently underway [2] - This therapy aims to address the issue of resistance to EGFR inhibitors, providing an all-oral, chemotherapy-free treatment option [2] Group 2 - The acceptance of this application will trigger milestone payments from AstraZeneca [3]

Investment Rating - The report assigns a "Buy" rating for the company, with a target price of 33.24 HKD for 2025 [8][18]. Core Insights - The company is a global small molecule innovative pharmaceutical enterprise, established in 2000, focusing on oncology with three commercialized products and several late-stage clinical drugs. It has achieved a revenue CAGR of 23.1% from 2017 to 2023 and recorded its first profit of 101 million USD in 2023 [17][59]. - The company is expanding its innovative products into international markets, with significant progress in the commercialization of its drugs, particularly focusing on the colorectal cancer indication for Furquintinib and the EGFR-TKI resistant market for Savolitinib [17][63]. Financial Summary - The company’s revenue for 2023 is projected at 426.41 million USD, with a year-on-year growth of 96.52%. The net profit attributable to the parent company is expected to be 100.78 million USD, marking a 127.93% increase [7]. - Forecasted revenues for 2024, 2025, and 2026 are 680.01 million USD, 844.08 million USD, and 1000.34 million USD, respectively, with corresponding growth rates of -18.85%, 24.13%, and 18.51% [7][18]. Product Pipeline and Market Strategy - The company has a robust pipeline with several products in various stages of development. Furquintinib is being marketed for gastrointestinal tumors and has recently been launched in major markets including the US, EU, and Japan. Savolitinib targets the EGFR-TKI resistant market and is expected to submit an NDA in the US soon [17][40][63]. - The company is also focusing on autoimmune diseases and hematological malignancies, with innovative products like Syk inhibitor Sogrolimab and IDH1/2 dual inhibitors for AML [17][60]. Management and Corporate Structure - The company is backed by a stable management team with extensive experience in drug discovery, development, and commercialization. The largest shareholder is Cheung Kong Holdings, holding 38.16% of the shares [54][56].

[Table_Page]公告点评|制药、生物科技与生命科学 证券研究报告 | --- | --- | --- | --- | --- | --- | --- | --- | --- | |------------------|--------------------------------------------------------|------------------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------|----------------|-----------------------------------------------------------------------------------------------------------|---------- ...

优于大市 和黄医药（00013.HK） 临床开发与商业化均取得进展 公司研究·海外公司快评 医药生物·化学制药 投资评级：优于大市（维持） 证券分析师：张佳博021-60375487zhangjiabo@guosen.com.cn 证券分析师：陈曦炳0755-81982939chenxibing@guosen.com.cn 执证编码：S0980523050001 执证编码：S0980521120001 事项： 公司公告：1）索乐匹尼布将于 12 月上旬的 ASH 年会上更新 ITP 中国 3 期临床数据；2）呋喹替尼于日本 推出上市；3）赛沃替尼按现行条款成功续约国家医保。 国信医药观点：1）索乐匹尼布在成人 ITP 患者中的持续应答率达到 51.4%且安全性良好，有望成为 BIC 的 Syk 抑制剂，根据当前审评进度，我们预计索乐匹尼布将于 2025 年在中国获批上市；2）呋喹替尼在今 年前三季度在美国实现超 2 亿美元的销售，并在今年下半年在日本、欧洲获批上市，预计将在明年延续海 外销售放量的趋势；3）赛沃替尼成功完成医保续约，且在 SAVANNAH 临床中取得积极结果，阿斯利康希望 凭借此临床数据向 F ...

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company successfully renewed the negotiation for the national medical insurance drug list for Savolitinib, with no price reduction in the recent negotiations. The drug is expected to be submitted for approval in the US by the end of 2024, following positive results from overseas Phase II clinical trials for second-line EGFRm+ MET-driven NSCLC [2] - The overseas sales of Fuzulopatinib continue to grow, and the company anticipates approval for new indications domestically. Fuzulopatinib is the first and only small molecule targeted drug approved for third-line mCRC in the US in the past decade, and it has been included in the NCCN guidelines. The drug has achieved net sales of $200 million overseas in the first three quarters of this year [2] - The potential best-in-class Syk inhibitor, Solitomab, has commenced overseas clinical trials. The number of existing ITP patients in China is expected to exceed 300,000 by 2027, with 67% of patients entering second-line treatment. The competition landscape is favorable due to limited innovative therapies [3] - The revenue forecasts for 2024-2026 are $665 million, $808 million, and $969 million, respectively, with profitability expected in 2025. The company has multiple catalysts in play, and the overseas market is opening up, indicating high growth certainty [3] Financial Summary - Total revenue (in million USD) is projected to be $665.00 in 2024, $808.00 in 2025, and $969.00 in 2026, with a year-on-year growth rate of -20.64% in 2024, followed by 21.50% in 2025 and 19.93% in 2026 [1][3] - The net profit attributable to the parent company is expected to be -$41.78 million in 2024, $48.83 million in 2025, and $178.71 million in 2026, with significant year-on-year growth rates of 216.88% and 265.95% in 2025 and 2026, respectively [1][3] - The latest diluted EPS is projected to be -$0.05 in 2024, $0.06 in 2025, and $0.21 in 2026 [1][3]

股 票 研 究 海 外 公 司 （ 中 国 香 港 ） 证 券 研 究 报 告 投资要点： 国泰君安版权所有发送给上海东方财富金融数据服务有限公司.东财接收研报邮箱.ybjieshou@eastmoney.com p1 呋喹替尼日本顺利获批，海外放量可期 [Table_Invest] 评级： ——和黄医药跟踪报告 | --- | |----------------------------------------| | | | 股票研究 /[ Table_Date] 2024.09.26 | | 和黄医药 (0013) | | [Table_Industry] 医药 | | 增持 | | --- | --- | --- | --- | |----------|-----------------------------------|----------------------------|--------------------------| | | | | | | | [table_Authors] 丁丹 ( 分析师 ) | 甘坛焕 ( 分析师 ) | 付子阳 ( 研究助理 ) | | | 0755-23976 ...

Investment Rating and Valuation - The report initiates coverage with a **BUY** rating for Hutchmed, with a target price of HK$35.4, implying a 33% upside potential [4][10] - Revenue is forecasted to reach $650M in 2024E, $810M in 2025E, and $950M in 2026E, with oncology/immunology business contributing $370M, $530M, and $650M respectively [4][10] - Net profit is expected to turn positive in 2025E, with forecasts of -$13M in 2024E, $39M in 2025E, and $120M in 2026E [4][10] Core Products and Commercialization - **Fruquintinib (Fruzaqla)**: Approved by the FDA in November 2023 for metastatic colorectal cancer (mCRC), with overseas sales reaching $15M in 2023 and $131M in 1H24 [4][7] - **Savolitinib**: Expected to file an NDA with the FDA by the end of 2024 for EGFRm/MET+ NSCLC, potentially becoming the second overseas product [4][7] - **Sovleplenib**: NDA for second-line immune thrombocytopenia (ITP) accepted by NMPA in January 2024, with peak sales in China estimated at $110M [11] Pipeline and R&D Progress - Hutchmed has 13 oncology drugs in clinical stages, with **HMPL-306 (IDH1/2)** entering Phase III for AML in May 2024 [4][7] - **Tazemetostat**: NDA for third-line follicular lymphoma accepted by NMPA in July 2024, with rights licensed in Greater China [4][7] - **Fruquintinib**: Additional indications under development include gastric cancer, endometrial cancer, and renal cell carcinoma [25][26] Market and Competitive Landscape - Fruquintinib is the first and only highly selective VEGFR inhibitor approved in the US for mCRC, with peak overseas sales potential of $670M [11][24] - In China, Fruquintinib holds a 47% market share in third-line mCRC as of 2Q24, with monthly treatment costs of ¥7,541, lower than Regorafenib's ¥14,488 [35][36] - Regorafenib, a competitor, saw a 15% decline in global sales to €523M in 2023 due to generic competition and Fruquintinib's market entry [38][39] Strategic Partnerships - Hutchmed partnered with **Takeda** for Fruquintinib's global commercialization (excluding China), receiving $400M upfront and up to $730M in milestone payments [4][12] - **AstraZeneca** is responsible for Savolitinib's marketing in China and is expected to file an NDA with the FDA by end of 2024 [4][7] - Collaboration with **Ipsen** for Tazemetostat's development and commercialization in Greater China [17]