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HUTCHMED Announces European Commission Approval for FRUZAQLA® (fruquintinib) Received by Takeda

GlobeNewswire News Room· 2024-06-21 20:00
— Approval for previously treated metastatic colorectal cancer based on results from positive, global, Phase III FRESCO-2 Trial — — FRUZAQLA® (fruquintinib) is the first novel targeted therapy in the EU for metastatic colorectal cancer regardless of biomarker status in over a decade — HONG KONG, SHANGHAI and FLORHAM PARK, N.J., June 21, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that its partner Takeda (TSE:4502/NYSE:TAK) has received notificati ...
和黄20240619
医药魔方· 2024-06-20 05:57
Summary of the Conference Call Company and Industry Overview - The conference call focused on **Hua Guang Pharmaceutical**, an innovative drug company that has recently gained attention for its differentiated product offerings and global collaborations [4][3]. Key Points and Arguments 1. **Product Portfolio**: The company has three products currently on the market: **Fugui Tianyi**, **Suo Huang Tianyi**, and **Sai Luo Tianyi**. A fourth product is in the process of being listed in Hainan and Macau [4][6]. 2. **Collaborations**: The company has established partnerships with multinational corporations, including **Eli Lilly** and **AstraZeneca**, as well as domestic innovative firms like **BeiGene** and **Innovent Biologics** for joint development [5][6]. 3. **Medicare Inclusion**: Key products, **Fugui Tianyi** and **Suo Huang Tianyi**, have been renewed in the Medicare directory without price reductions, indicating strong recognition and validation from the government [6][7]. 4. **Sales Performance**: In Q1 2023, **Fugui Tianyi** generated approximately **$50 million** in sales, with expectations for approval in Europe and Japan in 2024 [7][8]. 5. **Market Position**: The company holds a leading market share of approximately **47%** in the third-line treatment for colorectal cancer and is expanding into other indications such as second-line gastric cancer and endometrial cancer [8][9]. 6. **Future Revenue Projections**: Revenue forecasts for 2024 to 2026 are projected at **$290 million**, **$1.26 billion**, and **$1.58 billion**, respectively, with net profits expected to reach **$130 million**, **$240 million**, and **$350 million** [11][12]. 7. **Risks**: Potential risks include changes in industry policies, uncertainties in drug development, and the possibility of unmet sales expectations from collaborations [12][13]. Additional Important Information - **Clinical Trials**: The company is actively pursuing clinical trials for various indications, with expectations for approvals in the coming years, including second-line treatments for endometrial and renal cell cancers [13][36]. - **Market Dynamics**: The competitive landscape for second-line gastric cancer treatments is challenging, with a high failure rate historically for new entrants [64][65]. - **Sales Strategy**: The company has a structured revenue-sharing model with partners, with a range of **15% to 20%** based on sales performance, and additional milestone payments for achieving sales targets [57][59]. This summary encapsulates the key insights from the conference call regarding Hua Guang Pharmaceutical's current status, future outlook, and associated risks in the innovative drug industry.
和黄投资交流&深度报告解读东财
医药魔方· 2024-06-19 06:13
Summary of Conference Call Company/Industry Involved - The conference call involves Dongfang Caifu Securities, a financial services company in the securities industry [1] Core Points and Arguments - The analyst, He Wei, expresses gratitude to the audience and introduces the theme of the discussion, which is a deep report on Wang Yiyao [1] - The report has been recently released, indicating ongoing research and analysis efforts within the company [1] Other Important but Possibly Overlooked Content - The company reserves all legal rights regarding any violations mentioned, suggesting potential legal implications or concerns within the industry [1]
HUTCHMED Highlights Publication of Phase III ESLIM-01 Results in The Lancet Haematology

GlobeNewswire News Room· 2024-06-17 00:00
— Publication shows treatment demonstrated durable response rate of 48.4% vs. 0% with placebo — — Presentations at EHA showcased subgroup analyses demonstrating consistent benefits regardless of prior lines of therapies or prior TPO/TPO-RA1 exposure — — Data supported regulatory submission in China accepted in January 2024 — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 17, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that results from ESLI ...
HUTCHMED Highlights Publication of Phase III ESLIM-01 Results in The Lancet Haematology

Newsfilter· 2024-06-17 00:00
— Publication shows treatment demonstrated durable response rate of 48.4% vs. 0% with placebo — — Presentations at EHA showcased subgroup analyses demonstrating consistent benefits regardless of prior lines of therapies or prior TPO/TPO-RA1 exposure — — Data supported regulatory submission in China accepted in January 2024 — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 17, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that results from ESLI ...
和黄医药:港股公司首次覆盖报告:深度聚焦肿瘤小分子赛道,进入全球市场收获期
KAIYUAN SECURITIES· 2024-06-14 06:01
医药生物/化学制药 公 司 和黄医药(00013.HK) 深度聚焦肿瘤小分子赛道,进入全球市场收获期 研 究 2024年06月13日 ——港股公司首次覆盖报告 投资评级:买入(首次) 余汝意(分析师) 日期 2024/6/12 yuruyi@kysec.cn 当前股价(港元) 28.400 证 书编号:S0790523070002 一年最高最低(港元) 35.900/17.440 公司深度聚焦肿瘤小分子赛道,国际大药企助力开拓全球市场 总市值(亿港元) 247.44 流通市值(亿港元) 247.44 和黄医药是中国最早一批布局全球市场的新药研发企业之一,已实现在中、 港 总股本(亿股) 8.71 美、欧“三地”上市。公司共有三款上市产品,包括呋喹替尼、赛沃替尼和索凡 股 流通港股(亿股) 8.71 替尼,并已全部被纳入国家医保药品目录。为了更好地快速布局全球市场,公 公 近3个月换手率(%) 24.77 司 股价走势图 司先后与阿斯利康、礼来及武田制药等国际大药企建立战略合作关系。其中呋 首 次 喹替尼已经于 2023年在美国获批上市,并由武田制药负责海外市场的商业化销 和黄医药 恒生指数 覆 售。未来几 ...
和黄医药:深度研究:差异化布局,全球合作创新
East Money Securities· 2024-06-11 01:31
Investment Rating - The report upgrades the investment rating of Hutchison China MediTech (HCM) to "Buy" with a target price of HKD 55.78 [3][6] Core Views - HCM is an early-stage innovative pharmaceutical company with a differentiated portfolio and global collaborations, including partnerships with Eli Lilly, AstraZeneca, and Takeda [2] - The company has three commercialized products (Fruquintinib, Surufatinib, and Savolitinib) and a fourth candidate drug, Tazemetostat, approved in Hainan and Macau [2] - Fruquintinib, a $1 billion potential blockbuster, has been approved in China and the US, with expected approvals in Europe and Japan by 2024 [2] - Surufatinib has strong growth potential due to its dual anti-angiogenic and immunomodulatory activities, with collaborations for combination therapies [2] - Savolitinib, a first-in-class MET inhibitor, is expected to expand into first-line use and address unmet needs in MET-positive NSCLC patients [2] Financial Projections - Revenue is projected to grow from $890 million in 2024 to $1.575 billion in 2026, with a CAGR of 25% [6] - Net profit attributable to shareholders is expected to increase from $134 million in 2024 to $351 million in 2026, with a CAGR of 48% [6] - EPS is forecasted to grow from $0.15 in 2024 to $0.40 in 2026, with a P/E ratio declining from 25x to 10x [6] Product Pipeline and Market Potential - Fruquintinib maintains a leading position in the third-line colorectal cancer market and is expected to expand into second-line gastric cancer, endometrial cancer, and renal cell carcinoma [2][26] - Surufatinib is being developed for over 10 tumor types, including neuroendocrine tumors and pancreatic ductal adenocarcinoma, with a global NET market projected to grow to $21.5 billion by 2030 [48] - Savolitinib is being studied for MET-driven cancers, including NSCLC, gastric cancer, and renal cell carcinoma, with potential to address unmet needs in MET-positive patients [2][48] Collaborations and Commercialization - HCM has global collaborations with Eli Lilly for Fruquintinib in China and Takeda for international markets, with potential milestone payments and royalties [26][38] - The company successfully renewed the national medical insurance listing for Fruquintinib and Surufatinib without further price reductions, driving strong sales growth in 2023 [2][24] - Fruquintinib (FRUZAQLA) was launched in the US in November 2023, with sales reaching $15.1 million by year-end [40]
HUTCHMED Initiates Phase I Trial of Menin Inhibitor HMPL-506 in Patients with Hematological Malignancies in China

Newsfilter· 2024-06-07 00:00
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China. The first patient received their first dose on May 31, 2024. This is a Phase I, multicenter, open-label clinical study to evaluate the safety, pharmacokinetics and efficacy of HMPL-506 in patients with hematological mali ...
HUTCHMED Initiates Phase I Trial of Menin Inhibitor HMPL-506 in Patients with Hematological Malignancies in China

GlobeNewswire News Room· 2024-06-07 00:00
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China. The first patient received their first dose on May 31, 2024. This is a Phase I, multicenter, open-label clinical study to evaluate the safety, pharmacokinetics and efficacy of HMPL-506 in patients with hematological mali ...
HUTCHMED Highlights Publication of Phase III FRUTIGA Results in Nature Medicine

Newsfilter· 2024-06-03 00:00
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 03, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that results from FRUTIGA, HUTCHMED's Phase III trial of fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric cancer in China, were published in Nature Medicine. Updated efficacy data in key subgroups and data on quality of life (QoL) within this publication were also presented on June 1 at the American Soc ...