Core Insights - HUTCHMED's ORPATHYS (savolitinib) has received approval from the China National Medical Products Administration (NMPA) for treating both treatment-naïve and previously treated adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alteration [1][2][4] Company Developments - The approval was based on data from a confirmatory Phase IIIb clinical trial, which demonstrated significant efficacy and safety in both treatment-naïve and previously treated patients [2][4] - ORPATHYS was previously conditionally approved in June 2021 and has now transitioned to full approval, expanding its indication in China [1][9] - The drug is marketed in partnership with AstraZeneca, representing the first selective MET inhibitor approved in China [5][10] Clinical Data - In treatment-naïve patients, the objective response rate (ORR) was 62.1%, with a disease control rate (DCR) of 92.0% and a median duration of response (DoR) of 12.5 months [3] - For previously treated patients, the ORR was 39.2%, DCR was 92.4%, and median DoR was 11.1 months [3] - The median progression-free survival (PFS) for treatment-naïve patients was 13.7 months, while for previously treated patients, it was 11.0 months [3] Market Context - Lung cancer is the leading cause of cancer death globally, with a significant patient population in China, where over a third of the world's lung cancer patients reside [6] - Approximately 2-3% of NSCLC patients have tumors with MET exon 14 skipping alterations, which are targetable mutations [7] - The approval of ORPATHYS addresses unmet medical needs for NSCLC patients with MET aberrations, enhancing treatment options in this challenging area [4][5]

Group 1 - Monteverde & Associates PC is investigating Paycor HCM, Inc. regarding its proposed merger with Paychex, which will acquire Paycor at a price of $22.50 per share [1] - Monteverde & Associates PC has a successful track record in recovering millions of dollars for shareholders and is recognized as a Top 50 Firm by ISS Securities Class Action Services Report [1][2] - The firm operates from the Empire State Building in New York City and specializes in class action securities litigation [2][3] Group 2 - The firm encourages shareholders with concerns about Paycor HCM, Inc. to contact them for additional information free of charge [3] - Monteverde & Associates PC emphasizes that no company, director, or officer is above the law, highlighting their commitment to shareholder rights [3][4] - The firm has a history of litigating and recovering money for shareholders, including cases that have reached the U.S. Supreme Court [2][4]

Core Insights - Asure has appointed Jay Whitehead to lead its AsurePay™ Platinum VIP Banking card and Marketplace businesses, aiming to enhance its offerings in the Human Capital Management (HCM) sector [1][3]. Company Overview - Asure is a provider of cloud-based HCM software solutions that streamline HR processes for organizations of all sizes, including services like payroll, time and attendance, benefits administration, and talent management [5]. Leadership Background - Jay Whitehead has a rich background in HR and payment technology, having founded Human Resources Outsourcing Today and led various media and HR companies, which positions him well to drive Asure's initiatives [2]. Market Opportunity - Asure's payroll clients, representing nearly two million employees, have expressed a strong interest in the AsurePay™ Platinum VIP Banking card, which offers features superior to those of cards requiring $75,000 deposit minimums [3]. - The Asure Marketplace is seen as a valuable resource for companies to provide financial and consumer products to Asure's largely untapped payroll base [4].

Core Viewpoint - The article discusses the investment outlook for Paycor HCM (NASDAQ: PYCR), indicating a downgrade to a hold rating due to concerns about its growth potential [3]. Group 1: Company Analysis - Paycor HCM has been downgraded to a hold rating based on the analyst's lack of confidence in its ability to achieve growth [3]. - The investment approach focuses on identifying companies with solid fundamentals and sustainable competitive advantages, which is critical for long-term investment success [2]. Group 2: Investment Strategy - The investment strategy incorporates both long-term investments and short-term shorts to uncover alpha opportunities, emphasizing a bottom-up analysis of individual companies [2].

Core Viewpoint - Robbins LLP is investigating Paycor HCM, Inc. for potential violations of securities laws and breaches of fiduciary duties by certain officers and directors [1] Company Overview - Paycor HCM, Inc. provides human capital management solutions primarily for small and medium-sized businesses in the United States [1] Legal Context - Shareholders who have lost money in their investment in Paycor HCM, Inc. are encouraged to contact Robbins LLP for information about their rights [2] - Robbins LLP operates on a contingency fee basis, meaning shareholders incur no fees or expenses [3] Firm Background - Robbins LLP has been active in shareholder rights litigation since 2002, recovering over $1 billion for shareholders [4]

Core Insights - HUTCHMED will receive a US$10 million milestone payment from Takeda following the first national reimbursement recommendation for FRUZAQLA® (fruquintinib) in Europe for metastatic colorectal cancer [1][2] - FRUZAQLA® is the first novel oral targeted therapy approved in the EU for metastatic colorectal cancer in over a decade, with its European Commission approval granted in June 2024 [2][3] - The approval was based on the Phase III FRESCO-2 trial results, which demonstrated consistent benefits for patients treated with fruquintinib [3][6] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [7] - The company has approximately 5,000 personnel, with a significant focus on oncology and immunology [7] - HUTCHMED's fruquintinib has been co-marketed in mainland China, Hong Kong, and Macau with Eli Lilly under the brand name ELUNATE® [6] Industry Context - Colorectal cancer (CRC) is the third most prevalent cancer globally, with over 1.9 million new cases and 900,000 deaths reported in 2022 [4] - In Europe, CRC accounted for approximately 538,000 new cases and 248,000 deaths in 2022, highlighting the significant unmet medical need in this area [4] - The approval of FRUZAQLA® is expected to improve patient access to innovative treatments for metastatic CRC across Europe [3]

Core Insights - HUTCHMED will receive a US$10 million milestone payment from Takeda following the first national reimbursement recommendation for FRUZAQLA® (fruquintinib) in Europe for metastatic colorectal cancer [1][2] - FRUZAQLA® is the first novel oral targeted therapy approved in the EU for metastatic colorectal cancer in over a decade, with its European Commission approval granted in June 2024 [2][3] - The approval is based on the Phase III FRESCO-2 trial results, which demonstrated consistent benefits for patients treated with fruquintinib [3][6] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [7] - The company has approximately 5,000 personnel, with a significant focus on oncology and immunology [7] - HUTCHMED's fruquintinib has been co-marketed in mainland China, Hong Kong, and Macau under the brand name ELUNATE® in collaboration with Eli Lilly and Company [6] Industry Context - Colorectal cancer (CRC) is the third most prevalent cancer globally, with over 1.9 million new cases and 900,000 deaths reported in 2022 [4] - In Europe, CRC accounted for approximately 538,000 new cases and 248,000 deaths in 2022, highlighting the significant unmet medical need in this area [4] - The approval and reimbursement of FRUZAQLA® represent a critical advancement in treatment options for patients with metastatic CRC, particularly given the poor outcomes associated with this condition [4][5]

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]

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]

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Nov. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that following the contract renewal with the China National Healthcare Security Administration (“NHSA”), the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 2025 will continue to include ORPATHYS® (savolitinib) at the same terms as the current two-year agreement. ORPATHYS® is an oral, potent, and highly selective MET tyro ...