HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 31, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it will receive a US$20 million milestone payment from its partner Takeda (TSE:​4502/​NYSE:​TAK), triggered by reaching over US$200 million in sales of FRUZAQLA® (fruquintinib) for metastatic colorectal cancer (“CRC”). CRC is the second most common cause of cancer-related deaths in the US. There are approximately 840,000 new cases of CRC each ...

Independent Data Safety and Monitoring Board Endorsed Dose Escalation and Broadening of Eligibility Criteria; Cohort 2 Now Enrolling Initial Data from Cohort 1 to be Reported in December 2024 Highlights Recently Presented Insights on Pediatric MYBPC3-associated HCM Disease Burden SOUTH SAN FRANCISCO, Calif., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that add ...

— New data demonstrate efficacy for the oral treatment combination to address MET-driven resistance in EGFR-mutated lung cancer — — MET is a common biomarker in this setting for patients who develop resistance to EGFR targeted therapies — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 16, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces positive high-level results from the SAVANNAH Phase II trial that showed TAGRISSO® (osimertinib) plus ORPATHYS ...

Shares of HUTCHMED (China) Ltd (HCM, Financial) surged 2.90% in mid-day trading on Oct 2. The stock reached an intraday high of $21.10, before settling at $20.58, up from its previous close of $20.00. This places HCM 6.11% below its 52-week high of $21.92 and 72.44% above its 52-week low of $11.93. Trading volume was 210,051 shares, 216.8% of the average daily volume of 96,867. Wall Street Analysts Forecast Based on the one-year price targets offered by 12 analysts, the average target price for HUTCHMED (Ch ...

Patient randomization is underway in SONATA-HCM clinical trial evaluating Lexicon’s novel dual SGLT1 and SGLT2 inhibitor in this underserved and growing patient population  Study design intended to enable supplemental new drug application (sNDA) with a broad label in both obstructive and non-obstructive HCM THE WOODLANDS, Texas, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it will unveil study design details of SONATA-HCM, the company’s Phase 3 clinica ...

Investment Rating - The report maintains a "Buy" rating for the company [3][5]. Core Insights - Furazatin has been successfully approved in Japan as of September 24, 2024, for the treatment of advanced or recurrent colorectal cancer, which is not amenable to curative surgery or chemotherapy [6]. - The approval in Japan, along with previous approvals in the US and Europe, is expected to drive overseas sales to exceed $1 billion, indicating significant market potential [5][6]. - The report highlights the substantial burden of colorectal cancer globally, with approximately 1.93 million new cases and over 900,000 deaths reported in 2022 [6]. - The company has multiple pipelines progressing well, with the potential for additional drug submissions in the near future, including the NDA for Savolitinib expected by the end of 2024 [6]. Summary by Sections Approval and Market Potential - Furazatin is the first innovative targeted therapy approved in Japan for metastatic colorectal cancer in over a decade, enhancing treatment options available [6]. - The report anticipates that the peak overseas sales for Furazatin could surpass $1 billion, with expected pricing in Europe and Japan being 30%-40% and 20%-30% of US prices, respectively [6]. Financial Projections - The financial summary indicates projected revenues of $356 million in 2024, increasing to $926 million by 2026, with a notable growth rate of 97% from 2022 to 2023 [10]. - The report also notes a significant increase in net profit from a loss of $361 million in 2022 to a projected profit of $93 million in 2025 [10]. Pipeline Developments - The report outlines ongoing clinical trials and submissions for other drugs in the pipeline, including Savolitinib and Sovaldi, which are expected to enhance the company's market position [6].

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]

— Approval based on results from global Phase III FRESCO-2 trial in patients with previously treated metastatic colorectal cancer — — Fruquintinib already approved in several regions including the United States, Europe and China — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 24, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that its partner Takeda (TSE:​4502/​NYSE:​TAK) has received approval from the Japanese Ministry of Health, Labour and ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Sept. 09, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the 2024 World Conference on Lung Cancer (“WCLC24”) in San Diego, USA, and the European Society for Medical Oncology (“ESMO”) Congress 2024, taking place in Barcelona, Spain. Results from the FLOWERS study, a prospective, two-arm, randomized, mul ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Aug. 30, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has voluntarily withdrawn its supplemental New Drug Application (“NDA”) in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma and will evaluate a new route forward. Following an additional internal review of the current data package, in light o ...