Core Insights - 康方生物's HARMONi-6/AK112–306 study results were prominently presented at the ESMO 2025 and published in The Lancet, demonstrating the efficacy of Ivoris combined with chemotherapy compared to Tarelizumab combined with chemotherapy for advanced sq-NSCLC [1][2] Study Overview - HARMONi-6/AK112–306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivoris combined with chemotherapy versus Tarelizumab combined with chemotherapy as first-line treatment for advanced sq-NSCLC, with the primary endpoint being progression-free survival (PFS) evaluated by IRRC based on RECIST v1.1 [1][3] - The study enrolled 532 participants, with a balanced baseline, and 92.3% of subjects being in stage IV; the characteristics of squamous cell carcinoma were consistent with real-world patient distribution, with approximately 63% being central squamous cell carcinoma [1][3] Efficacy Results - The study achieved a significant positive result for the primary endpoint of PFS, with Ivoris showing a marked improvement over the control group, resulting in a PFS hazard ratio (HR) of 0.60 (p<0.0001) [1][2] - The median PFS for the Ivoris group was 11.14 months compared to 6.9 months for the control group, indicating an absolute improvement of 4.24 months in PFS [1][2] Subgroup Analysis - In the PD-L1 negative population (TPS ≤ 1%), the median PFS was 9.9 months versus 5.7 months, with a PFS HR of 0.55 [2] - In the PD-L1 positive population (TPS ≥ 1%), the median PFS was 12.6 months versus 8.6 months, with a PFS HR of 0.66 [2] - The PFS HR for patients with liver metastases was 0.53, while for those without liver metastases, it was 0.64; for patients with three or more baseline metastatic sites, the PFS HR was 0.46 [2] Safety Profile - The overall safety profile of the Ivoris group was favorable, with no new safety signals identified; the incidence of treatment-related serious adverse events and grade 3 or higher bleeding events was similar to the control group [2] Regulatory Status - The new indication application for Ivoris combined with chemotherapy for first-line treatment of sq-NSCLC has been accepted by the CDE and is currently under review, potentially offering hope to more patients [2]

Core Insights - The clinical trial results of HARMONi-6 / AK112-306 were prominently presented by Professor Lu Shun at the ESMO 2025 and published in The Lancet, demonstrating the efficacy of Ivosidenib combined with chemotherapy for advanced sq-NSCLC [1][2] Group 1: Clinical Trial Overview - HARMONi-6 / AK112-306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivosidenib combined with chemotherapy versus Toripalimab combined with chemotherapy as first-line treatment for advanced sq-NSCLC [1][2] - The study enrolled 532 participants, with 92.3% of subjects in clinical stage IV, and the characteristics of squamous cell carcinoma were consistent with real-world patient distribution [1][2] Group 2: Key Findings - Ivosidenib combined with chemotherapy achieved a significant improvement in progression-free survival (PFS) compared to Toripalimab, with a hazard ratio (HR) of 0.60 and a p-value of <0.0001 [1] - The median PFS for the Ivosidenib group was 11.14 months, while the control group had a median PFS of 6.9 months, resulting in an absolute improvement of 4.24 months [1] Group 3: Subgroup Analysis - Significant benefits of Ivosidenib were observed across various subgroups, including those with different PD-L1 expression levels and liver metastasis status [1] - In the PD-L1 negative population, the median PFS was 9.9 months versus 5.7 months (HR = 0.55) [1] - In the PD-L1 positive population, the median PFS was 12.6 months versus 8.6 months (HR = 0.66) [1] Group 4: Safety Profile - The overall safety profile of the Ivosidenib group was favorable, with no new safety signals identified, and the incidence of treatment-related serious adverse events was similar to the control group [1]

Core Viewpoint - Kangfang Biopharma (09926.HK) announced significant results from the HARMONi-6/AK112–306 study, which were presented by Professor Lu Shun at the ESMO 2025 and published in The Lancet, indicating a strong clinical benefit of Ivoris combined with chemotherapy over Tarelizumab combined with chemotherapy for advanced sq-NSCLC [1] Group 1: Study Overview - HARMONi-6/AK112–306 is a randomized, controlled, multi-center Phase III clinical trial assessing Ivoris combined with chemotherapy versus Tarelizumab combined with chemotherapy as first-line treatment for advanced sq-NSCLC [1] - The primary endpoint of the study is progression-free survival (PFS) evaluated by IRRC based on RECIST v1.1, with key secondary endpoints including overall survival (OS) [1] - A total of 532 subjects were enrolled in the HARMONi-6 study, with baseline characteristics balanced between the two groups, and 92.3% of subjects being classified as stage IV [1] Group 2: Study Results - The trial results demonstrated that Ivoris combined with chemotherapy achieved the primary endpoint of PFS, showing a decisive positive outcome with significant statistical and clinical benefits [1] - The Ivoris group significantly extended patient PFS compared to the control group, aligning with real-world patient distribution, where approximately 63% of cases were central squamous cell carcinoma [1]

香 港 交 易 及 結 算 所 有 限 公 司 及 香 港 聯 合 交 易 所 有 限 公 司 對 本 公 告 之 內 容 概 不 負 責，對其準確性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部 或任何部分內容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 Akeso, Inc. 康 方 生 物 科 技（ 開 曼 ）有 限 公 司 （於 開 曼 群 島 註 冊 成 立 的 有 限 公 司） 康方生物科技（ 開曼 ）有限公司（「本公司」，連同其附屬公司統稱「本集團」）自願刊 發，以告知本公司股東及潛在投資者有關本集團最新業務發展的資料。 本公 司董事會（「董事會」）欣然 宣布，HARMONi-6 / AK112 – 306 的研 究結果 由主要 研究、上海市胸科醫院腫瘤科主任陸舜教授在2025歐洲腫瘤內科學會(ESMO)的主 席論壇上重磅發布，並在國際頂級醫學期刊《柳葉刀》（ THE LANCET ）主刊同步發 表。 HARMONi-6 / AK112 – 306（ CTR20231272 / NCT 05840016 ）是一項評估依沃西聯合化療 對比替雷利珠聯合化療一線治療晚期sq-NSCL ...

Group 1: Semiconductor Industry - Citi maintains an "outperform" rating for SMIC with a target price of HKD 59.2, reporting a 1.7% quarter-over-quarter revenue decline to USD 2.21 billion, which is better than expected. Gross margin was 20.4%, exceeding the 18-20% forecast range, while net profit was USD 132.5 million, 24% below market expectations. Q3 revenue is expected to grow by 7% quarter-over-quarter to USD 2.34 billion, slightly below market expectations [1] - Citi maintains an "outperform" rating for Hua Hong Semiconductor, raising the target price to HKD 50.5. The company began price adjustments in Q2, which are expected to reflect in the second half, leading to a single-digit increase in average selling prices. The 2026 and 2027 earnings forecasts were raised by 18% and 12%, respectively, while the 2023 earnings forecast was lowered by 31% due to increased taxes [2] Group 2: Pharmaceutical Industry - CMB International maintains a "buy" rating for BeiGene with a target price of HKD 225, noting that Q2 2025 performance exceeded expectations, with core product sales continuing to grow. The company is positioned as a benchmark for Chinese innovative drugs, with strong global sales of its products. The second half of 2025 is expected to be a critical period for new product approvals and clinical data releases, which may catalyze stock price growth [2] Group 3: Gaming and Hospitality Industry - CICC maintains an "outperform" rating for MGM China, reporting Q2 2025 results that exceeded expectations, with net income and adjusted EBITDA recovering to pre-pandemic levels, driven by strong performance in Macau. Management expects continued strong performance during the summer and is focused on product updates and high-end market segments [3] Group 4: Telecommunications Infrastructure - CICC maintains a "strong buy" rating for China Tower, highlighting its position as a global leader in communication infrastructure. The company's strategic layout and shared mechanisms are expected to release significant profits as existing assets depreciate. Long-term growth is anticipated from new business drivers and deepened sharing mechanisms [4] Group 5: Consumer Goods Industry - CICC maintains an "outperform" rating for Uni-President China, reporting H1 2025 results that exceeded market expectations. The beverage business remains stable amid increased competition, while the food business continues to grow. Cost advantages and improved capacity utilization are driving margin improvements, with a steady growth trend expected for the year [5] Group 6: Technology Industry - CICC maintains an "outperform" rating for Xiaomi Group with a target price of HKD 70, forecasting a 64.84% year-over-year increase in adjusted net profit for Q2 2025. The company remains among the top three globally in smartphone shipments, with strong IoT revenue expected. The release of new production capacity is anticipated to enhance order delivery [6] - CICC maintains a "buy" rating for AsiaInfo Technologies, noting that while H1 2025 revenue was pressured by cost-cutting measures from operators, innovative business trends are positive. Revenue from AI model applications and delivery services is expected to grow significantly, helping to stabilize overall revenue [7] Group 7: Robotics Industry - CICC initiates coverage on Yujiang with an "outperform" rating and a target price of HKD 61, highlighting the company's focus on collaborative robots and product line expansion. The company is expected to show significant growth potential and diverse international business layouts [8] Group 8: Medical Services Industry - Citi maintains an "outperform" rating for Tigermed with a target price of HKD 62.6, noting an 83% increase in stock price year-to-date as the Chinese innovative drug market improves. Net profit forecasts for 2025-2027 have been raised by 31%, 30%, and 30%, respectively, with positive sales growth in Q2 [9]

Group 1: Company Overview - 豪威集团 (OmniVision Technologies) - The automotive intelligent driving business is driving record high revenues, with a closing price of RMB 121.22 and a target price of RMB 180.00, indicating a potential upside of +48.5% [1] - The net profit for 1H25 was in line with expectations, with a median net profit of RMB 1.98 billion and revenue median of RMB 13.87 billion, attributed to a slowdown in smartphone shipments affecting image sensor product revenues [1][2] - The automotive CIS chip market share is steadily increasing in panoramic and action camera segments, contributing to a historical high in revenue for 2Q25 [1] Group 2: Financial Projections - 豪威集团 (OmniVision Technologies) - Revenue forecasts for 2025/26 have been adjusted down to RMB 31.1 billion and RMB 36.8 billion, respectively, with slight adjustments to net profit estimates for the same years [2] - The diluted EPS for 2025/26 is projected at RMB 3.98 and RMB 5.24, maintaining a target price of RMB 180, corresponding to a 39x average P/E ratio for 2025/26 [2] Group 3: Company Overview - 高途 (Gaotu Techedu) - The education business shows strong performance with a projected 31% year-on-year revenue growth for Q2 2025, driven by robust growth in K9 business and better-than-expected growth in high school segments [3] - Despite controlled offline business investments and ongoing operational efficiency improvements, increased AI-related expenditures have led to an adjusted operational loss of RMB 250 million for Q2 [3] - The target price for Gaotu is set at USD 4.80, reflecting a 33% potential upside based on a 15x P/E ratio for online education [3] Group 4: Company Overview - 百济神州 (BeiGene) - The company reported a 41% year-on-year revenue growth in Q2 2025, reaching USD 1.3 billion, exceeding market expectations [6] - Sales of the drug Zejula increased by 49% year-on-year to USD 950 million, with significant growth in both the US and European markets [6] - The target price for BeiGene has been raised to HKD 225.00, indicating a potential upside of +23.2% [6][7] Group 5: Financial Projections - 百济神州 (BeiGene) - Revenue guidance for the full year has been raised to a range of USD 5.0 billion to USD 5.3 billion, with a gross margin target of 80-90% [6] - The company has also increased its peak sales forecasts for Zejula and another drug, with projected peak sales of USD 7.3 billion and USD 900 million, respectively [7]

Group 1 - The core viewpoint is that the company is optimistic about the overseas approval prospects of Ivosidenib (依沃西) for treating 2L+ EGFRm NSCLC, as the treatment options are limited and the efficacy in the HARMONi study is significantly better than current chemotherapy regimens [1] - The company has initiated multiple Phase III studies in mainland China this year, covering large patient populations with limited treatment options, including first-line colorectal cancer, first-line pancreatic cancer, and PD-(L)1 resistant NSCLC [1] - The broad indication layout and the high efficacy with low toxicity characteristics of Ivosidenib are gradually clarifying its path to becoming a new generation I/O cornerstone drug, potentially replacing PD-(L)1 single-target therapies [1] Group 2 - The company has recently received approval for the third indication of Cadonilimab (卡度尼利) for first-line cervical cancer in the entire population and is expected to participate in the medical insurance negotiations in the second half of the year [2] - An overseas Phase II study of Cadonilimab in combination with Lenvatinib for second-line liver cancer, following treatment failure with Atezolizumab and Bevacizumab, is being initiated [2] - The differentiated ADC development strategy is progressing well, with the first ADC (HER3) entering clinical trials and the first bispecific ADC AK146D1 completing its first patient enrollment [2] Group 3 - Key short-term catalysts include: 1) Overseas submission and complete data release of the HARMONi study; 2) Presentation of the AK112-306 study (head-to-head against Tremelimumab for 1L squamous NSCLC) at ESMO 2025; 3) Results of medical insurance negotiations for multiple products/indications in Q4 2025, including Cadonilimab for first-line gastric cancer and cervical cancer, Ivosidenib for first-line PD-L1+ NSCLC, AK101, and AK102; 4) Advancement of more early-stage projects such as ADCs [3]

青侨阳光医药投资 - 行业思考 1 医药出海 中国创新药市场在过去10年迎来高速发展，按我们的估计，创新药在中国药品市场中的比重已经从约5%增加 到10%以上，整个市场规模也从小几百亿增长到接近2000亿的体量，已经足以支撑起一批数百亿乃至一两千亿 人民币市值的上市药企。 但这样的规模体量放在海外创新药市场面前依然是不够看的：2023年海外创新药占药品总市场的比重接近 60%，年销售规模折合人民币高达6-7万亿人民币，仅仅一款帕博利珠单抗2024全年超2000亿人民币的销售额 就能超过整个中国创新药行业的体量，只是美国一个国家近3万亿的创新药市场就比整个中国创新药行业大10 多倍。 也就是说， 中国创新药通过10年高速发展，在全球创新药市场的比重也就从1%-2%的份额提升到3%左右， 即使以每年15%-20%的速度再发展10年，中国市场占全球创新药的比重也很难超过10% 。 是专注于国内这3%的市场，还是打通国外那97%的市场？这里的选择是不言而喻的。 对于每一家有着远大志 向的创新药企来说，"出海"都是必选项，因为那里的天地远比国内更宽广。 中国创新药的出海之路有几个关键节点。 药监政策层面上： 海外市场准 ...