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Core Insights - Edgewise Therapeutics, Inc. reported topline data from the Phase 2 CIRRUS-HCM trial for EDG-7500, targeting obstructive and nonobstructive Hypertrophic Cardiomyopathy (HCM) [1][2] Group 1: Trial Results - In Part A of the trial, a single oral dose of EDG-7500 showed significant reductions in left ventricular outflow tract gradient (LVOT-G) without affecting left ventricular ejection fraction (LVEF) [2] - Part B included 17 participants with obstructive HCM, while Part C included 12 with nonobstructive HCM, both evaluating the safety and efficacy of once-daily doses of 50 or 100 mg of EDG-7500 for four weeks [3] - Participants receiving 100 mg experienced mean reductions of 71% in resting LVOT-G and 58% in provokable (Valsalva) gradients, achieved without meaningful changes in LVEF [6] Group 2: Biomarker and Clinical Improvements - In nonobstructive HCM participants, a 42% mean decrease in NT-proBNP was observed at the 100 mg dose [4] - Significant improvements in Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) and Clinical Summary Scores were noted, with mean increases of 17 points and 22 points, respectively, at the 100 mg dose after four weeks [4] - Treatment with 100 mg of EDG-7500 resulted in a 62% mean reduction in NT-proBNP, a key heart failure biomarker, and 78% of participants improved by at least one NYHA Class, with 67% improving to NYHA Class I [6] Group 3: Future Outlook - Initial data from Part D of the trial is expected in the second half of 2025, with Phase 3 initiation planned for the first half of 2026 [4]

Core Viewpoint - HUTCHMED's TAZVERIK® (tazemetostat) has received conditional approval from the NMPA in China for treating adult patients with relapsed or refractory follicular lymphoma with EZH2 mutations, marking a significant milestone for the company in hematological malignancies [1][3]. 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 [10]. - TAZVERIK® is HUTCHMED's fourth product and its first approval in the field of hematological malignancies [1][3]. Product Details - TAZVERIK® is the first and only EZH2 inhibitor approved by the NMPA, following a multicenter Phase II bridging study in China and clinical studies conducted by Epizyme, Inc. [1][2]. - The approval is based on the objective response rate, duration of response, progression-free survival, and overall survival in patients with relapsed or refractory follicular lymphoma [2]. - TAZVERIK® has previously been approved in the Hainan Pilot Zone, Macau, and Hong Kong, indicating a growing acceptance in the Asia-Pacific region [4]. Clinical Studies - The ongoing SYMPHONY-1 study will serve as a confirmatory trial to validate the clinical benefits of TAZVERIK® in combination with rituximab and lenalidomide for patients with relapsed or refractory follicular lymphoma [5]. - The study is designed as an international, multicenter, randomized, double-blind, active-controlled trial [5]. Market Context - Follicular lymphoma is the second most common subtype of non-Hodgkin's lymphoma, accounting for 20-30% of all NHL cases, with an estimated 81,000 new cases in China in 2022 [6]. - The approval of TAZVERIK® addresses a significant unmet medical need for patients suffering from this challenging disease [3].

Core Viewpoint - HUTCHMED (China) Limited announces the retirement of two Independent Non-executive Directors, Mr. Paul Rutherford Carter and Mr. Graeme Allan Jack, effective after the upcoming annual general meeting on May 13, 2025, leading to changes in the board's composition and committee leadership [1][2][3]. Board Changes - Mr. Paul Rutherford Carter and Mr. Graeme Allan Jack will not seek re-election and will retire from the Board at the AGM, ceasing their roles as chairmen and members of board committees [1][2]. - Professor Mok Shu Kam, Tony will be appointed as Senior and Lead Independent Non-executive Director, and Mr. Wong Tak Wai will become the chairman of the Audit Committee [2][6]. - Dr. Chaohong Hu will join the Audit Committee, and Dr. Renu Bhatia will chair the Remuneration Committee [6]. Contributions of Retiring Directors - Mr. Carter has significantly influenced the company's remuneration policies, aiding in employee retention and motivation [3]. - Mr. Jack has played a crucial role in overseeing financial reporting and audit processes, ensuring integrity and transparency [3]. Company Overview - HUTCHMED is a biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [4]. - The company has successfully marketed three medicines in China, with the first also approved globally, including in the US, Europe, and Japan [4].

Core Viewpoint - HUTCHMED (China) Limited announces the retirement of two Independent Non-executive Directors, Mr. Paul Rutherford Carter and Mr. Graeme Allan Jack, effective after the upcoming annual general meeting on May 13, 2025, leading to changes in the board composition and committee leadership [1][2][3]. Board Changes - Mr. Paul Rutherford Carter and Mr. Graeme Allan Jack will not seek re-election and will retire from the Board at the AGM, ceasing their roles as chairmen and members of board committees [1][2]. - Professor Mok Shu Kam, Tony will be appointed as Senior and Lead Independent Non-executive Director, and Mr. Wong Tak Wai will become the chairman of the Audit Committee and a member of the Remuneration Committee [2][6]. - Dr. Chaohong Hu will join the Audit Committee, and Dr. Renu Bhatia will chair the Remuneration Committee [6]. Contributions of Retiring Directors - Mr. Carter has significantly influenced the company's remuneration policies and practices, aiding in employee retention and motivation [3]. - Mr. Jack has played a crucial role in overseeing financial reporting and audit processes, ensuring integrity and transparency [3]. Company Overview - HUTCHMED is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [4]. - The company has successfully marketed its first three medicines in China, with the first also approved globally, including in the US, Europe, and Japan [4].

Core Insights - The SAVANNAH Phase II trial demonstrated high and durable response rates for savolitinib combined with TAGRISSO® in patients with MET-high lung cancer, indicating a promising oral treatment strategy for advanced cases [1][2][3] - Long-term survival benefits and safety were observed in the Phase IIIb study of savolitinib for patients with METex14 NSCLC, particularly in treatment-naïve patients [1][7] Group 1: SAVANNAH Phase II Trial Results - The SAVANNAH Phase II trial showed a confirmed objective response rate (ORR) of 56% (95% CI: 45%–67%) and a median duration of response (DoR) of 7.1 months (95% CI: 5.6–9.6) for savolitinib plus TAGRISSO® [3][4] - The median progression-free survival (PFS) was reported as 7.4 months (95% CI: 5.5–7.6) [3] Group 2: Safety Profile - Safety results indicated that Grade 3 or higher adverse events occurred in 57% of patients, with 32% experiencing Grade 3 or higher treatment-related adverse events [4] - No new safety concerns were reported, aligning with the established safety profiles of the medications involved [4] Group 3: Phase IIIb Study Outcomes - In the Phase IIIb study, treatment-naïve patients had a median overall survival (OS) of 28.3 months (95% CI: 17.5–not evaluable), with a 36-month OS rate of 44.7% [7] - Previously treated patients had a median OS of 25.3 months (95% CI: 20.5–30.5), with a 24-month OS rate of 51.7% [7] Group 4: Drug Development and Approval - Savolitinib is a selective MET tyrosine kinase inhibitor developed by AstraZeneca and HUTCHMED, which received Fast Track Designation from the FDA in 2023 [5][14] - The drug is approved in China under the brand name ORPATHYS® for patients with MET exon 14 skipping alterations [8][15] Group 5: Surufatinib Study Insights - Surufatinib combined with PD-1/PD-L1 antibodies showed durable survival benefits in extensive-stage small cell lung cancer (SCLC) patients, with 12-month and 18-month OS rates of 57.1% for maintenance therapy [9] - The exploratory study involved 21 patients, with a median follow-up duration of 17.1 months for maintenance therapy [9] Group 6: Company Overview - HUTCHMED is a biopharmaceutical company focused on the discovery and commercialization of targeted therapies for cancer and immunological diseases [19] - The company has successfully brought multiple drug candidates to market, with its first three medicines approved in China and one also approved globally [19]

GLOBAL COMMERCIAL PORTFOLIO NEXT-GENERATION INNOVATIVE PLATFORM 0000po HUTCHMED March 2025 Nasdaq/AIM:HCM | HKEX:13 Safe harbor statement & disclaimer The performance and results of operations of the HUTCHMED Group contained within this presentation are historical in nature, and past performance is no guarantee of future results. 2 Agenda Weiguo Su Opening 1 Chief Executive Officer & Chief Scientific Officer Financial review & outlook Johnny Cheng 2 Chief Financial Officer Commercial delivery George Yuan 3 ...

Financial Performance - Total consolidated revenue for 2024 was $630.2 million, down from $838.0 million in 2023[10]. - Revenue for the year ended December 31, 2024 was $630.2 million compared to $838.0 million in 2023, reflecting a decrease of approximately 25%[31]. - Net income for 2024 was $37.7 million, with a cash balance of $836.1 million as of December 31, 2024[6]. - Net income attributable to HUTCHMED for 2024 was $37.7 million compared to $100.8 million in 2023, representing a decline of about 63%[33]. - Cash, cash equivalents, and short-term investments were $836.1 million as of December 31, 2024, down from $886.3 million as of December 31, 2023[34]. - Consolidated revenue from Other Ventures decreased by 14% to $266.8 million in 2024, primarily due to lower COVID-related prescription drug distribution sales[148]. - Revenue from the distribution business decreased by 11% to $262.8 million, attributed to lower COVID-related prescription drug distribution sales[149]. - Dividends received from SHPL in 2024 amounted to $34.9 million, down from $42.3 million in 2023, with total dividends received since inception exceeding $360 million[154]. Oncology Product Sales - Oncology product in-market sales increased by 134% to $501.0 million in 2024, compared to $213.6 million in 2023[8]. - Consolidated revenue from oncology products rose by 65% to $271.5 million in 2024, up from $164.2 million in 2023[8]. - FRUZAQLA's ex-China in-market sales reached $290.6 million in 2024, a significant increase from $15.1 million in 2023[11]. - ELUNATE's in-market sales in China grew by 7% to $115.0 million in 2024, maintaining its market share in metastatic colorectal cancer[12]. - In-market sales of HUTCHMED's novel oncology products grew 134% to $501.0 million in 2024, primarily driven by the launch of FRUZAQLA[54]. - Fruquintinib achieved in-market ex-China sales of $290.6 million in 2024, triggering a $20 million milestone payment from Takeda for reaching $200 million in annual sales[57]. - ELUNATE in China achieved in-market sales of $115.0 million in 2024, up 7% compared to 2023[59]. - ORPATHYS in-market sales decreased 2% to $45.5 million in 2024, with royalties and manufacturing revenue consolidating to $24.5 million[63]. - Surufatinib (SULANDA) in-market sales increased by 12% to $49.0 million in 2024, maintaining a 27% prescription share in NET treatment[65]. Research and Development - The company plans to expedite the development of its new ATTC platform, targeting a wide range of oncology indications[7]. - R&D expenses were reduced by 30% to $212.1 million, primarily due to restructuring efforts outside of China[35]. - The SAVANNAH global Phase II study showed a high confirmed overall response rate (ORR) of 90.5% for EGFRm NSCLC patients treated with savolitinib and TAGRISSO, compared to 60.9% for TAGRISSO monotherapy[82]. - The SANOVO China Phase III study continues to enroll patients, focusing on treatment-naïve patients with EGFRm and MET overexpression[82]. - Approximately 100 investigator-initiated trials for fruquintinib and surufatinib are ongoing in various solid tumor settings in China[104][110]. Regulatory Approvals - Savolitinib's NDA in China was accepted and granted priority review following positive interim analysis results for EGFRm NSCLC patients[6]. - Fruquintinib approved in the EU for CRC in June 2024, followed by first European reimbursement in Spain in December 2024, triggering a $10.0 million milestone from Takeda[16]. - Savolitinib NDA accepted by the NMPA with Priority Review status for 2L EGFRm NSCLC patients in December 2024, triggering a milestone from AstraZeneca[16]. - Fruquintinib sNDA approved by the NMPA for 1L and 2L METex14 NSCLC in January 2025, converting from conditional to full approval[16]. - Tazemetostat's NDA for R/R follicular lymphoma was accepted for review by the NMPA in July 2024, with priority review status granted[68]. - The NDA for sovleplenib in primary ITP was accepted for priority review by the NMPA in January 2024[114]. - The NDA for tazemetostat in China was accepted with priority review status in July 2024[121]. Strategic Transactions - The company agreed to a partial disposal of its equity in the SHPL joint venture for $608 million[6]. - HUTCHMED entered into share purchase agreements to divest its 45.0% equity interest in SHPL for approximately $608 million in cash, retaining a 5.0% equity interest[26]. - The estimated gain on disposal for HUTCHMED is approximately $477 million before taxation, considering the carrying value of the shares sold[153]. - HUTCHMED received shares representing approximately 7.5% of Inmagene in July 2024 as part of a strategic partnership to develop novel drug candidates[137]. Cost Management - Selling and administrative expenses decreased to $112.9 million, reflecting tighter controls over administrative and selling costs[35]. - Staff costs for the year ended December 31, 2024, totaled $190.9 million, a decrease from $213.7 million in 2023[196]. Market Conditions - The Consumer Price Index in China increased by 0.1% in 2024, indicating low inflation impact on the company's operations[190].

Financial Performance and Funding - For the year ended December 31, 2024, HUTCHMED provided $20.0 million to its PRC subsidiaries, a decrease of 93.55% compared to $310.0 million in 2023[48]. - Dividends received by the Hong Kong immediate holding company of the non-consolidated joint venture totaled approximately $34.9 million, $42.3 million, and $43.7 million for the years ended December 31, 2024, 2023, and 2022, respectively[49]. - HUTCHMED has not provided any funds to its PRC subsidiaries for the year ended December 31, 2024, indicating a shift in funding strategy[48]. - Shareholder loans to PRC subsidiaries were $20.0 million in 2023, down from $210.0 million in 2022, reflecting a significant reduction in funding through this method[48]. - The company experienced negative cash flows from operations, with net cash used in operating activities amounting to $268.6 million in 2022[64]. - In 2023, the company generated net cash of $219.3 million from operating activities, followed by $0.5 million in 2024[64]. - As of December 31, 2023, the company's short-term investments were valued at $602.7 million, increasing to $682.1 million by December 31, 2024[71]. - The accounts receivable balance, net of allowance for credit losses, totaled $116.9 million in 2023 and increased to $155.5 million in 2024[72]. Regulatory and Legal Risks - The company faces significant legal and operational risks due to substantial operations in China, including regulatory approvals and potential government interventions[39]. - The PRC government has indicated an intent to exert more oversight over overseas offerings, which could impact HUTCHMED's operations and market access[44]. - HUTCHMED's operations are subject to various regulatory approvals, and future changes in laws could impose additional burdens on its business[42]. - The company is subject to extensive government regulations in China, which may impose additional burdens on operations and affect the ability to obtain necessary permits and licenses[142]. - The company may face legal and financial repercussions if unable to comply with evolving data protection laws, including potential fines and reputational damage[206]. - The company faces potential liabilities under various anti-corruption laws, including the U.S. Foreign Corrupt Practices Act and Chinese anti-corruption laws, which could adversely affect its business and reputation[226]. Drug Development and Commercialization - The company incurred significant commercialization expenses related to the drug surufatinib (marketed as Sulanda), which was approved in China in December 2020[63]. - The successful commercialization of drug candidates savolitinib, fruquintinib, and surufatinib is uncertain, with potential market challenges impacting revenue generation[75]. - The company may need substantial additional funding for product development and commercialization efforts, which could lead to delays or reductions in these efforts if capital is not raised on acceptable terms[63]. - The company focuses on developing kinase inhibitors, aiming for global best-in-class therapies, but faces risks in demonstrating safety and efficacy in clinical trials[81]. - The company may face challenges in capitalizing on potentially more profitable drug candidates due to limited financial and managerial resources[83]. - The development of the next-generation in-house platform for antibody-targeted therapy conjugates (ATTCs) is uncertain, with clinical trials expected to initiate in late 2025[85]. - The company has received regulatory approval for fruquintinib and surufatinib for specific cancer treatments, but ongoing regulatory requirements remain substantial[92]. - The company is developing combination therapies using its drug candidates with various immunotherapies, but it does not manufacture or sell these combination therapeutics[93]. - Clinical development is a lengthy and expensive process with uncertain outcomes, and the company may face delays or failures in its drug candidates[100]. - The company may incur additional costs or experience delays in completing pre-clinical or clinical trials due to unforeseen events[102]. - The company may face regulatory delays if clinical trials are suspended or terminated, which could lead to denial of regulatory approval for drug candidates[104]. - The company has experienced a Complete Response Letter from the FDA regarding the NDA for surufatinib, indicating that a multi-regional clinical trial is required for U.S. approval[117]. - The company anticipates seeking priority review for certain drug candidates in the future, having previously received priority review status for several candidates[119]. - Regulatory approvals may come with limitations on indicated uses and requirements for costly post-marketing testing, which could affect the company's ability to achieve profitability[124]. - The inability to enroll a sufficient number of patients in clinical trials could result in significant delays and may require the abandonment of trials[107]. - The company faces competition from other ongoing clinical trials, which may affect patient enrollment in its own trials[108]. - Undesirable side effects from drug candidates could lead to interruptions in clinical trials and affect regulatory approval outcomes[111]. - The company plans to conduct additional clinical trials outside the United States, but FDA acceptance of data from these trials is not guaranteed[116]. Competition and Market Dynamics - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may have greater financial resources and expertise[98]. - The commercial opportunity could be reduced if competitors develop safer or more effective drugs, or if they obtain regulatory approval more rapidly[99]. - The company faces substantial competition in the pharmaceutical industry in China, with established large pharmaceutical companies and smaller emerging firms competing for market share[151]. - The tender process for generic prescription drugs in China, initiated in 2018, may reduce the product portfolio of the company's Other Ventures as some partners may fail to win bids[161]. - The company must adapt its sales and marketing strategies to effectively compete against products with lower prices or superior performance[152]. - The ability to recruit and retain effective sales and marketing personnel is critical for the company's success in commercializing its drug candidates[153]. Operational and Supply Chain Risks - The company relies on third-party growers and suppliers for key raw materials, and any supply disruptions could adversely affect product sales and operating results[168]. - The finished products of fruquintinib and surufatinib are manufactured at the facility in Suzhou, China, with plans to manufacture at a new facility in Shanghai[172]. - The company relies on third-party manufacturers for the active pharmaceutical ingredients of fruquintinib, surufatinib, and savolitinib, which poses a risk if these suppliers cease operations[185]. - Disruptions at manufacturing facilities could materially affect the company's ability to produce and ship products, impacting financial position and results of operations[174]. - The company has faced historical power shortages that could lead to production shutdowns and increased costs[176]. - Collaborations with partners such as AstraZeneca, Eli Lilly, and Takeda are critical for drug development, and any disputes could delay product development[179]. - The company may face challenges in negotiating new collaborations, which could curtail development plans and require additional capital[184]. - The reliance on third-party contract research organizations (CROs) for clinical trials could lead to delays or failures in obtaining regulatory approval if they do not meet obligations[189]. - Compliance with regulatory requirements for clinical trials is essential, as failures could result in fines and delays in the approval process[194]. - The company aims to maintain adequate inventory of active pharmaceutical ingredients, but interruptions could impede development and commercialization efforts[187]. - The loss of any major suppliers could significantly harm the company's business and financial condition[185]. Data Privacy and Cybersecurity - The company is subject to stringent privacy and cybersecurity laws, with potential risks related to the management of medical data from clinical trials[206]. - The PRC Personal Information Protection Law took effect in November 2021, establishing requirements for processing personal information[211]. - The Measures on Security Assessment of Cross-border Data Transfer became effective on September 1, 2022, imposing security assessments for exporting important data[212]. - The company has not received any formal notice regarding the need for cybersecurity review or security assessment as of the report date[211][212]. - The company is subject to European data privacy laws, including GDPR, and non-compliance could lead to significant fines and negative publicity[215]. - The company may incur substantial operational costs to comply with data privacy and cybersecurity laws, which could impact its financial condition[216]. - Cybersecurity incidents could result in the loss of critical data, affecting clinical activities and increasing recovery costs[234]. Environmental and Compliance Risks - The company and its joint ventures are subject to numerous environmental, health, and safety laws, with potential fines and penalties for non-compliance that could adversely affect business success[231]. - There is a risk of employee misconduct, including non-compliance with regulatory standards, which could result in significant fines or sanctions[230]. - The company may incur substantial capital expenditures to comply with new environmental regulations, which could impact business operations[232]. - The company has adopted a Code of Ethics to mitigate risks associated with employee misconduct, but effectiveness in controlling risks is uncertain[230]. - The company relies on third parties for waste disposal, which poses risks of contamination or injury that could lead to liability exceeding available resources[231]. - Future environmental expenditures may vary significantly due to unanticipated regulatory changes, impacting financial planning[232]. Shareholder and Management Relations - CK Hutchison indirectly held approximately 38.2% of the total outstanding share capital as of February 15, 2025[200]. - Management fees paid to CK Hutchison for shared services were approximately $1.0 million in 2022 and 2023, increasing to $1.1 million in 2024[201]. - Sales of products to CK Hutchison group members amounted to $3.6 million in 2022 and $1.9 million in 2023[201]. Miscellaneous - The company may experience earnings volatility due to strategic transactions, including acquisitions and divestitures, which could impact future revenue[222]. - The company is required to make significant milestone payments for in-licensing or collaboration agreements, which may not guarantee long-term profitability[223]. - The company’s operations may be disrupted if employees are suspected of contracting an epidemic disease, leading to potential quarantines[220]. - The company’s compliance with healthcare fraud and abuse laws is critical, as violations could result in severe penalties and disrupt operations[227]. - Share-based compensation expenses recognized were $30.6 million, $36.6 million, and $21.6 million for the years ended December 31, 2022, 2023, and 2024, respectively[235]. - The company is heavily dependent on information technology systems, which are vulnerable to security incidents that could disrupt operations and lead to significant costs[234].

Core Insights - HUTCHMED reported a significant growth in oncology products revenue, achieving a 65% increase to $271.5 million in 2024, driven by a 134% rise in total oncology product in-market sales to $501.0 million [6][8][10] - The company reached profitability ahead of schedule, with a net income of $37.7 million for 2024, supported by a strong cash balance of $836.1 million as of December 31, 2024 [6][36][37] - HUTCHMED is advancing its pipeline with promising clinical results and the introduction of a new Antibody-Targeted Therapy Conjugate (ATTC) platform, which is expected to enhance drug development [5][24][38] Commercial Operations - Oncology product in-market sales increased by 134% to $501.0 million in 2024, compared to $213.6 million in 2023, with FRUZAQLA (fruquintinib) ex-China sales reaching $290.6 million [8][12] - ELUNATE (fruquintinib in China) sales grew by 7% to $115.0 million, maintaining a leading market share in metastatic colorectal cancer [9][34] - The company achieved a consolidated revenue of $630.2 million in 2024, down from $838.0 million in 2023, primarily due to lower revenue from other ventures [32][39] Pipeline Progress - HUTCHMED's pipeline includes several key products, with savolitinib achieving positive interim analysis results in the SACHI Phase III trial for EGFRm NSCLC, leading to a swift NDA filing [6][16][18] - Positive results from the SAVANNAH global pivotal Phase II trial for savolitinib in combination with TAGRISSO were shared with global regulatory authorities [6][18] - The ATTC platform is expected to yield new drug candidates that are more selective and tolerable than previous generations, enhancing the company's R&D capabilities [24][29] Financial Performance - The company reported a net income of $37.7 million in 2024, a decrease from $100.8 million in 2023, with earnings per share dropping to $0.04 from $0.12 [36][44] - Total operating expenses decreased to $673.9 million in 2024 from $819.6 million in 2023, reflecting strong cost control measures [35][44] - Cash and cash equivalents decreased to $836.1 million as of December 31, 2024, compared to $886.3 million in the previous year [37][43] Regulatory Updates - Savolitinib received NDA acceptance with Priority Review status for 2L EGFRm NSCLC patients with MET amplification, and full approval for METex14 NSCLC was granted in January 2025 [16][19] - Fruquintinib was approved in multiple countries, including the EU and Japan, for colorectal cancer, with significant sales milestones achieved [19][24] - The company is actively engaging with regulatory authorities to expedite the approval process for its innovative medicines [6][16]