Group 1 - Fuhong Hanlin's stock price increased by over 5%, reaching a new historical high of 81.35 HKD, with a trading volume of 178 million HKD [1] - The company had 10 lung cancer research abstracts selected for the 2025 World Lung Cancer Conference (WCLC), including 4 oral presentations and 2 poster discussions, covering key clinical scenarios in non-squamous/squamous non-small cell lung cancer (nsNSCLC/sqNSCLC) and extensive small cell lung cancer (ES-SCLC) [1] - The selected studies focus on three core innovative drugs: anti-PD-1 monoclonal antibody H drug Hanshu (sulizumab), anti-EGFR monoclonal antibody HLX07, and the world's first PD-L1 ADC HLX43, which has entered Phase II clinical trials [1] Group 2 - Citigroup anticipates that Fuhong Hanlin will present the latest data on HLX43 at the WCLC, which will further reveal its potential in treating non-small cell lung cancer (NSCLC) [2] - If HLX43 maintains an objective response rate (ORR) of 35% to 40% and a median progression-free survival (mPFS) of approximately 5.5 months in a larger sample, the data will be highly persuasive [2] - Citigroup estimates that the global study for third-line NSCLC treatment could start as early as the first half of 2026, with a risk-adjusted peak sales estimate for HLX43 reaching around 2.3 billion USD, indicating potential for further upside if more data is obtained [2]

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) experienced a significant stock price increase, attributed to the acceptance of its innovative drug, Aditinib (TY-9591), for a key Phase II registration clinical trial in treating EGFR-mutant non-small cell lung cancer (NSCLC) [1] Company Summary - The company's stock rose over 10% in early trading and is currently up 4.78%, priced at 18.2 HKD with a trading volume of 32.2051 million HKD [1] - Aditinib (TY-9591) is a highly selective small molecule inhibitor targeting classic EGFR gene mutations, aimed at addressing unmet clinical needs in NSCLC patients with brain metastases [1] - The drug has shown excellent efficacy in controlling brain metastases and alleviating symptoms, potentially offering a new and more effective first-line treatment option for EGFR-mutant NSCLC patients with brain metastases [1] Industry Summary - The acceptance of the clinical trial results at the 2025 World Lung Cancer Conference (WCLC) highlights the ongoing advancements in targeted therapies for lung cancer, particularly for patients with specific genetic mutations [1] - The focus on brain metastases in NSCLC treatment reflects a growing recognition of the need for effective therapies in this challenging area of oncology [1]

Core Viewpoint - Johnson & Johnson's Amivantamab has received approval for a new indication in China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1][2] Group 1: Drug Approval Details - Amivantamab is now approved in combination with Lenzatinib for first-line treatment of NSCLC patients with EGFR 19 exon deletions or L858R mutations [1] - This marks the third indication for Amivantamab in China, following its initial approval for EGFRex20ins mutation NSCLC in February 2025 and a subsequent approval for use with chemotherapy in April 2025 [2] Group 2: Global Approval History - Amivantamab was first granted accelerated approval in the United States in May 2021 [2] - To date, Amivantamab has received a total of four indications globally for the treatment of non-small cell lung cancer [2]

Core Viewpoint - CICC maintains its profit forecast for Hutchison China MediTech (00013) at $360 million for 2025 and $100 million for 2026, with a target price of HKD 30, indicating a 20.5% upside from the current stock price [1] Group 1: Drug Approval and Market Potential - The recently approved indication for Savolitinib is the largest for the drug to date [2] - Approximately 10-25% of non-small cell lung cancer (NSCLC) patients in the US and Europe have EGFR mutations, while the rate is as high as 30-40% in Asian patients [2] - MET amplification is a major mechanism of acquired resistance in EGFR-mutant NSCLC patients, with 15-50% of patients showing MET abnormalities after third-generation EGFR TKI treatment [2] Group 2: Clinical Trial Results - The approval is based on the SACHI Phase III study, which showed significant progression-free survival (PFS) benefits compared to platinum-based chemotherapy [3] - In the SACHI intent-to-treat population, the median PFS for the Savolitinib + Osimertinib combination was 8.2 months and 7.2 months, compared to 4.5 months and 4.2 months for the chemotherapy group, reducing the risk of disease progression by 66% and 60% respectively [3] Group 3: Ongoing Clinical Trials and Regulatory Progress - The SAFFRON Phase III clinical trial is ongoing, focusing on regulatory registration progress overseas [4] - The combination therapy received Fast Track designation from the FDA in 2023, with AstraZeneca conducting the SAFFRON trial to evaluate its effectiveness against platinum-based doublet chemotherapy in MET-overexpressing NSCLC [4] - Attention is recommended on the data readout from SAFFRON in 2026 and the overseas application status [4]

Core Viewpoint - The approval of the novel drug Amivantamab by Hansoh Pharmaceutical marks a significant breakthrough in the treatment of non-small cell lung cancer (NSCLC) in China, addressing a critical unmet medical need for postoperative patients with EGFR mutations [1][4]. Group 1: Drug Approval and Market Impact - On May 9, 2025, Hansoh Pharmaceutical announced that its self-developed class I new drug, Amivantamab, received approval from the National Medical Products Administration for use in adult patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations after tumor resection [1]. - The approval allows Amivantamab to break the monopoly of imported drugs in this field, achieving parallel coverage with imported drugs and marking a significant advancement for domestic innovative targeted drugs in the comprehensive treatment of NSCLC [3]. Group 2: Clinical Significance and Expert Opinions - Professor Cheng Ying from the Chinese Society of Clinical Oncology highlighted that the high recurrence rate of operable NSCLC patients post-surgery indicates a substantial unmet treatment need, and the approval of Amivantamab provides new hope for long-term survival [4]. - The third-generation EGFR-TKI has become the standard treatment for EGFR-mutated NSCLC, and the rapid development of innovative targeted drugs in China has allowed them to catch up with international drugs [4]. - Since its approval in 2020, Amivantamab has made significant progress in the treatment of NSCLC, and the new indication expands its use from first-line and second-line treatments to adjuvant therapy, solidifying its position in the treatment landscape [4].