Core Insights - HUTCHMED's combination therapy of ORPATHYS® and TAGRISSO® has received Breakthrough Therapy Designation from China's NMPA for treating advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after progression on EGFR inhibitors [1][3] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases, employing approximately 5,000 personnel [15] - The company has a collaboration with AstraZeneca for the global development and commercialization of ORPATHYS®, with HUTCHMED leading development in China [12] Drug Development and Trials - The ongoing Phase III SACHI trial is evaluating the efficacy and safety of the ORPATHYS® and TAGRISSO® combination against standard platinum-based chemotherapy in NSCLC patients with MET amplification [2][8] - ORPATHYS® has been conditionally approved in China for patients with MET exon 14 skipping alterations and is included in the National Reimbursement Drug List since March 2023 [9] - The combination has shown promising results in previous studies, leading to the initiation of multiple Phase III trials, including SANOVO and SAFFRON [5][8] Disease Context - Lung cancer is the leading cause of cancer death, with NSCLC accounting for 80-85% of cases; approximately 30-40% of NSCLC patients in Asia have EGFR mutations [4] - MET amplification is a significant mechanism of resistance to EGFR TKIs, with 15-50% of patients experiencing disease progression post-osimertinib presenting with MET aberration [4][10]

Investment Rating - The report assigns a "Buy" rating to the company with a current price of HKD 26.90 and a fair value of HKD 41.35 [2][13]. Core Insights - The approval of a new indication for furmonertinib (also known as Ivoritinib) in combination with sintilimab for the treatment of advanced mismatch repair-deficient (pMMR) endometrial cancer patients has been highlighted as a significant event [2][6]. - The company is expected to benefit from the unmet medical needs in the endometrial cancer field, with furmonertinib and sintilimab potentially becoming more effective treatment options [2][6]. - The report emphasizes the rapid commercialization progress of furmonertinib overseas, with net sales reaching USD 203 million in the first nine months of 2024, leading to a milestone payment of USD 20 million for the company [6][13]. Financial Projections - The company's revenue projections for 2024E are USD 640.7 million, with a year-over-year growth rate of -23.55% [7]. - The oncology/immunology business is expected to contribute significantly to revenue, with projections of USD 362.2 million in 2024E [7]. - The report forecasts a return to profitability with net profits of USD 5 million in 2024E and USD 20 million in 2025E, reflecting a substantial growth rate of 335.3% [7][19]. Valuation Metrics - The report calculates a WACC of 10.34% and a perpetual growth rate of 3%, leading to a fair value estimate of HKD 41.35 per share [10][13]. - The company is projected to achieve a net profit margin of 3.0% by 2025E, with an expected ROE of 2.6% [19]. Product Pipeline and Market Potential - The report notes that furmonertinib is in various clinical stages with multiple immune checkpoint inhibitors, indicating a robust pipeline and potential for future growth [2][6]. - The upcoming submission for the registration study of savolitinib in combination with osimertinib for EGFR-resistant NSCLC is anticipated to open new revenue streams [6].

Core Insights - The New Drug Application for the combination of fruquintinib and sintilimab has received conditional approval in China for treating advanced endometrial cancer patients with pMMR tumors who have failed prior systemic therapy and are not candidates for curative surgery or radiation [1][2][3] Company Insights - HUTCHMED and Innovent Biologics are collaborating on the development of fruquintinib and sintilimab, with HUTCHMED focusing on extending the clinical benefits of fruquintinib to a broader patient population [3][15] - Innovent aims to provide innovative treatment options that improve survival rates and quality of life for patients with advanced endometrial cancer [3][16] Clinical Study Insights - The approval was supported by data from the FRUSICA-1 study, which showed an objective response rate (ORR) of 35.6% and a disease control rate (DCR) of 88.5% for the combination therapy [2] - The median progression-free survival (PFS) and overall survival (OS) were reported at 9.5 months and 21.3 months respectively, indicating promising efficacy [2][3] Market Context - Endometrial cancer remains a significant global health challenge, with approximately 417,000 diagnoses and around 97,000 deaths reported in 2020 [6] - In China, there were an estimated 82,000 new cases of endometrial cancer in 2020, highlighting the unmet need for effective treatments in this area [6] Product Insights - Fruquintinib is a selective oral inhibitor of all three VEGF receptors, designed to inhibit tumor angiogenesis and enhance selectivity [7] - Sintilimab, marketed as TYVYT®, is a PD-1 monoclonal antibody that reactivates T-cells to kill cancer cells and has multiple approved indications in China [11][12]

Investment Rating - The investment rating for the company is "Outperform the Market" (maintained) [1][12][21] Core Views - The company has made progress in both clinical development and commercialization, with key products showing strong sales potential and positive clinical data [2][12] - The core product, Furquintinib, is experiencing rapid overseas sales growth, while the company expects to submit a new drug application for Savolitinib to the FDA based on positive clinical results [2][8] - The clinical data for Syk inhibitor, Solitomab, is promising, with expectations for approval in China by 2025 [3][6] Summary by Sections Clinical Development - Solitomab has shown a sustained response rate of 51.4% in adult ITP patients, with a median cumulative time of 38.9 weeks for platelet counts ≥50x10^9/L [3][6] - Furquintinib achieved over $200 million in sales in the U.S. during the first three quarters of the year and is expected to continue its sales growth in Japan and Europe [2][7] - Savolitinib has successfully renewed its listing in the national medical insurance directory and is expected to submit an application to the FDA based on positive results from the SAVANNAH clinical trial [8][12] Financial Forecast - Revenue projections for 2024-2026 are $659 million, $818 million, and $932 million, respectively, with year-on-year growth rates of -21.3%, 24.0%, and 14.0% [2][12] - The net profit attributable to the parent company is forecasted to be -$12 million, $61 million, and $108 million for the same period [2][12]

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]

Core Viewpoint - HUTCHMED announces the renewal of the contract with the China National Healthcare Security Administration, ensuring that ORPATHYS® will remain on the National Reimbursement Drug List effective January 1, 2025, under the same terms as the previous agreement [1]. Group 1: Product Information - ORPATHYS® (savolitinib) is a selective MET tyrosine kinase inhibitor approved in China for treating non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations [2][5]. - The drug was first included in the National Reimbursement Drug List on March 1, 2023, highlighting the Chinese government's focus on improving drug affordability [3]. - ORPATHYS® is jointly developed by HUTCHMED and AstraZeneca, and it is the first selective MET inhibitor approved in China and included in the NRDL [5]. Group 2: Market Context - As of the end of 2023, approximately 1.33 billion people in China had basic medical insurance, covering around 95% of the population, which supports the market potential for ORPATHYS® [3]. - The NRDL is updated annually, and the inclusion of drugs is subject to a renewal process every two years, indicating a structured approach to drug reimbursement in China [3]. Group 3: Clinical Development - ORPATHYS® has shown clinical activity in advanced solid tumors and is currently under development for multiple tumor types, including lung, kidney, and gastric cancers [4][5].

— Launch follows approval by Japanese Ministry of Health, Labour and Welfare in September 2024 — — Milestone payment to be made to HUTCHMED from Takeda — — Fruquintinib already launched in several regions including the United States, Europe and China — HONG KONG, SHANGHAI & FLORHAM PARK, N.J., Nov. 21, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will receive a milestone payment following the pricing approval and launch of FRUZAQLA® (fruqui ...

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM:HCM, HKEX:13) today announces that Dr Chaohong Hu (Dr Mary Hu) is appointed as an Independent Non-executive Director and a member of the Technical Committee of the Company with effect from November 21, 2024. Dr Hu has over 20 years of experience in the development of therapeutic antibodies, antibody-drug conjugates, and vaccines. Throughout her career, she has d ...

Core Viewpoint - Johnson Fistel, LLP is investigating Paycor HCM, Inc. for potential violations of securities laws related to misrepresentation or failure to disclose material information affecting investors [1]. Group 1: Investigation Details - The investigation focuses on the losses suffered by investors and the possibility of recovering these losses under federal securities laws [1]. - Shareholders who purchased Paycor HCM securities and experienced losses are encouraged to join the investigation [2]. Group 2: Whistleblower Information - Individuals with nonpublic information about Paycor HCM are advised to consider assisting the investigation or utilizing the SEC Whistleblower program, which may offer rewards up to 30% of any successful recovery [3]. Group 3: About the Law Firm - Johnson Fistel, LLP is a nationally recognized shareholder rights law firm with offices in California, New York, Georgia, and Colorado, representing both individual and institutional investors in securities class action lawsuits [4].

Core Insights - HUTCHMED is set to present new data from the ESLIM-01 Phase III trial of sovleplenib and other investigator-initiated studies at major upcoming medical conferences, including the ASH Annual Meeting and ESMO Asia Congress in December 2024 [1][4] Group 1: ESLIM-01 Phase III Trial Data - Long-term safety and efficacy data from the ESLIM-01 Phase III study of sovleplenib in adult patients with chronic primary immune thrombocytopenia (ITP) will be reported, with 179 patients treated as of January 31, 2024 [2][3] - The overall response rate for patients was 81% (145/179), with a durable response rate of 51.4% and a long-term durable response rate of 59.8% [3] Group 2: Upcoming Presentations - The ASH Annual Meeting will feature a follow-on sub-study demonstrating the effectiveness of long-term treatment with sovleplenib in maintaining platelet counts in adults with chronic primary ITP [2][3] - The ESMO Asia Congress will include studies on fruquintinib combined with serplulimab for advanced non-clear cell renal cell carcinoma and other cancer treatments [4][6] Group 3: Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases, employing approximately 5,000 personnel [7]