Core Viewpoint - Cathay Securities maintains an "Overweight" rating for Kangfang Biopharma (09926), highlighting the company's core products achieving clinical breakthroughs and entering a revenue-generating phase, with revenue forecasts of 3.728 billion, 5.928 billion, and 7.800 billion yuan for 2025-2027, respectively, and a target price of 123.72 HKD for 2025 [1] Group 1 - Ivosidenib has received NMPA approval for first-line treatment of PD-L1 positive (TPS≥1%) NSCLC, marking it as the first drug to achieve significant positive results in head-to-head trials against the leading drug, Pembrolizumab [2] - Ivosidenib has shown significant positive results in three Phase III studies in lung cancer, including its efficacy against EGFR-TKI resistant NSCLC and in comparison to Pembrolizumab for first-line treatment of PD-L1 positive NSCLC [2] Group 2 - In the ITT population, the median progression-free survival (mPFS) for the Ivosidenib group was 11.14 months compared to 5.82 months for the Pembrolizumab group, with a hazard ratio (HR) of 0.51 (P<0.0001), indicating significant clinical survival benefits [3] - The interim analysis of median overall survival (mOS) showed that Ivosidenib reduced the risk of death by 22.3% compared to Pembrolizumab, although the statistical significance requires further observation due to low maturity of the data [3] Group 3 - The company continues to advance its overseas lung cancer initiatives, with its partner Summit leading Phase III registration trials comparing chemotherapy with third-generation EGFR-TKI treatments and other combinations against Pembrolizumab in various NSCLC settings [4]

Core Viewpoint - The Hong Kong pharmaceutical stocks have experienced a decline, with notable drops in several companies' share prices, indicating a bearish trend in the sector [1] Company Performance - Kangfang Biotech (09926.HK) saw a significant drop of 15.07% in its share price [1] - Yiming Oncology-B (01541.HK) decreased by 9.75% [1] - Zai Lab (09688.HK) fell by 6.43% [1] - Akeso-B (01167.HK) experienced a decline of 5.37% [1] - Terns Pharmaceuticals-B (02137.HK) dropped by 5% [1]

Core Insights - The performance of actively managed equity funds focused on humanoid robots is currently lagging behind, while funds heavily invested in innovative pharmaceuticals have emerged as top performers, with the Huatai-PineBridge Hong Kong Advantage Selected Mixed Fund (QDII) A achieving a year-to-date return of 64.44% as of April 27 [1][2] Fund Performance - As of April 27, the Huatai-PineBridge Hong Kong Advantage Selected Mixed Fund (QDII) A has a year-to-date return of 64.44%, making it the best-performing public fund this year [1] - The top ten holdings of this fund include Rongchang Biologics, Kelun-Botai Biologics-B, Innovent Biologics, and others, indicating a strong focus on leading pharmaceutical companies [1] - Several other pharmaceutical-themed funds have also shown significant returns, with funds like Changcheng Pharmaceutical Industry Selected Mixed Fund and Yongying Pharmaceutical Innovation Selected Mixed Fund exceeding 40% year-to-date returns [1] Market Trends - The pharmaceutical sector has seen a notable increase in stock prices, particularly in the innovative drug segment, with stocks like Rongchang Biologics and Innovent Biologics showing year-to-date increases of over 200% and nearly 50%, respectively [2] - Key breakthroughs in research and development have acted as catalysts for the pharmaceutical market, with recent approvals for innovative drugs such as the PD-1/VEGF bispecific antibody by Kangfang Biologics [2] Market Dynamics - The performance of Hong Kong-listed pharmaceutical stocks has shown greater elasticity compared to A-shares, attributed to the overall higher quality of Hong Kong's innovative drug companies and recent liquidity improvements in the market [3] - The current pharmaceutical market is characterized by a positive cycle of technological breakthroughs, policy support, and globalization, with significant growth in the number and value of overseas transactions by Chinese innovative drug companies [3][4] Future Outlook - The current innovative drug market is at a stage of heightened global competitiveness, with core stocks expected to maintain reasonable valuations without forming bubbles, allowing for potential earnings based on fundamental performance [4] - Key catalysts to watch for in 2025 include critical clinical data disclosures, overseas market authorizations for major products, performance realization of listed products, and new product negotiations with insurance [4]

Core Viewpoint - The approval of the new indication for the bispecific antibody Iwosimab (PD-1/VEGF) for first-line treatment of PD-L1 positive non-small cell lung cancer (NSCLC) marks a significant advancement in cancer therapy in China, allowing patients to access a leading global treatment option [1][2]. Group 1: Drug Approval and Clinical Results - Iwosimab has received approval from the National Medical Products Administration (NMPA) for use in treating locally advanced or metastatic NSCLC with negative EGFR mutations and ALK [1]. - The approval is based on positive results from a randomized, double-blind, controlled Phase III clinical trial (AK112–303/HARMONi-2), where the median progression-free survival (PFS) for Iwosimab was 11.14 months compared to 5.82 months for Pembrolizumab, demonstrating a 49% reduction in the risk of disease progression or death (PFS HR=0.51, P<0.0001) [1][2]. - A mid-term analysis of overall survival (OS) at 39% maturity showed that Iwosimab significantly reduced the risk of death by 22.3% compared to Pembrolizumab (OS HR=0.777) [2]. Group 2: Future Plans and Ongoing Research - The company plans to hold a business highlights communication meeting on April 28, 2025, with details to be announced on its official website and public account [2]. - Iwosimab is currently undergoing 12 Phase III clinical studies, including 3 international multicenter trials, and has a total of 18 ongoing clinical trials covering various cancers such as lung cancer, cholangiocarcinoma, head and neck squamous cell carcinoma, triple-negative breast cancer, colorectal cancer, pancreatic cancer, and hepatocellular carcinoma [3].

Core Viewpoint - 康方生物's drug Ivosidenib has shown strong positive results in head-to-head clinical trials against other leading PD-1 inhibitors, raising expectations for the company's financial recovery and market position [1][2][3]. Group 1: Clinical Trial Results - Ivosidenib (PD-1/VEGF dual antibody) demonstrated significant improvement in progression-free survival (PFS) compared to Tislelizumab in a Phase III head-to-head trial for advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2]. - The trial involved 532 participants from 66 clinical research centers, with Ivosidenib showing clinically meaningful PFS benefits in both PD-L1 positive and negative populations [2]. - Ivosidenib previously outperformed Pembrolizumab (Keytruda) in a separate Phase III trial, achieving an objective response rate (ORR) of 50% compared to 38.5% for Keytruda, and a disease control rate (DCR) of 89.9% versus 70.5% [3]. Group 2: Financial Performance - 康方生物 reported a revenue of 4.526 billion yuan in 2023, achieving its first annual profit, but faced a loss of 501 million yuan in 2024 despite generating 2.124 billion yuan in revenue [4]. - The company's financial performance is closely tied to Ivosidenib's sales, which generated 103 million yuan in revenue shortly after its market approval in May 2024 [4]. Group 3: Future Prospects - Ivosidenib is currently involved in 12 ongoing Phase III clinical trials, with one indication in the final review stage for supplemental new drug application [5]. - Goldman Sachs predicts that Ivosidenib could become a leader in the PD-1/L1×VEGF dual-specific antibody market, potentially reaching peak sales of 53 billion dollars by 2041 [5]. - 康方生物 also has other products in its pipeline, including a PD-1/CTLA-4 dual antibody and a recently FDA-approved drug for nasopharyngeal carcinoma [5].

Core Insights - Kangfang Biopharma announced the approval of its independently developed PD-1/VEGF bispecific antibody drug, Iwosimab (generic name: Iwosimab injection), for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 positive (TPS≥1%) and negative EGFR mutations and ALK [1][2] - Iwosimab is the first drug to achieve significant positive results in a head-to-head Phase III clinical study against the leading drug, Pembrolizumab, providing a new, more efficient, and safer "chemotherapy-free" treatment option for first-line NSCLC [1] - The approval of Iwosimab for first-line treatment of PD-L1 positive NSCLC marks its second indication, allowing Chinese patients to access the world's best treatment options first [1] Clinical Recognition and Future Prospects - Iwosimab has gained widespread recognition among clinicians and patients for its efficacy in treating EGFR-TKI resistant NSCLC since its market launch nearly a year ago [2] - Recent Phase III studies comparing Iwosimab combined with chemotherapy against Tremelimumab combined with chemotherapy for first-line treatment of squamous NSCLC have also shown significant positive results, establishing Iwosimab as a new standard treatment [2] - Kangfang Biopharma's founder, Dr. Xia Yu, highlighted that Iwosimab has a forward-looking layout in multiple core tumor immunotherapy indications, with nearly 30 clinical studies underway, including Phase III and Phase II trials, covering nearly 20 indications, creating a leading advantage for its clinical and commercial value globally [2]

Core Insights - The approval of the bispecific antibody drug Ivosidenib for the treatment of PD-L1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC) is a significant milestone for the biopharmaceutical industry [2] - Ivosidenib's approval is based on positive results from the HARMONi-2 clinical trial, which demonstrated significant improvements in median progression-free survival (PFS) and overall survival (OS) [2] - Goldman Sachs predicts that if Ivosidenib succeeds in multiple indications, it could reshape the $90 billion immuno-oncology market, potentially making it the "new king of drugs" [3] Company Developments - Kangfang Biopharma's stock price has surged over 50% in the past month following the approval of Ivosidenib [3] - Summit Therapeutics, the U.S. partner of Kangfang Biopharma, saw its stock price plummet by over 36% after the approval announcement, raising concerns about the market's reaction [3] - The market speculates that the decline in Summit's stock may be due to investors shifting their focus to Kangfang Biopharma, which holds rights to Ivosidenib in China, allowing it to generate revenue sooner [3] Clinical Data Insights - Despite the favorable PFS data, the OS data does not show statistical significance, leading to concerns among investors regarding the drug's approval prospects in the U.S. [4] - The FDA considers OS as a critical endpoint for cancer treatment approval, while PFS is often used to assess the drug's efficacy in controlling tumor progression [4] - Analysts suggest that the OS curve data may not be available until later this year at a medical conference, with further interim analysis not expected until late 2025 or early 2026 [4]

Group 1 - The Hong Kong innovative drug sector has rebounded rapidly due to a favorable external environment, with the China Securities Hong Kong Innovative Drug Index (931787) experiencing a significant recovery since its low on April 9, 2023 [1][3] - As of April 25, 2023, the index reached a peak of 979.92 points, showing a maximum cumulative increase of 37.43% from its previous low [1] - The overall increase in the Hong Kong innovative drug sector has outperformed the Hang Seng Technology Index, which has only seen a year-to-date increase of 12.48% compared to the innovative drug index's 31.03% [3] Group 2 - Recent data indicates a collective performance improvement among Hong Kong innovative drug companies, significantly exceeding market expectations [4] - In 2024, 10 out of 12 Hong Kong innovative drug companies with a market capitalization over 10 billion HKD reported positive revenue growth, with 8 companies also showing positive profit growth [4] - The company with the highest revenue growth is CloudTop New Drug-B (01952), with a revenue growth rate of 341.8%, while Innovent Biologics (01801) reported a net profit growth of 91.8% [4] Group 3 - The trend of "going global" has become a key topic, with Chinese pharmaceutical companies achieving significant growth in overseas licensing transactions [6][8] - The total transaction amount for licensing-out by Chinese pharmaceutical companies reached a historical high of 51.9 billion USD in 2024, indicating a strong global competitiveness in innovative drug development [6] - The NewCo model has emerged as a favorable strategy for domestic biotech companies, allowing for cash flow support and risk sharing in international collaborations [8] Group 4 - New industry trends in pharmaceuticals, such as weight-loss drugs, dual-antibody drugs, ADC drugs, and innovative medical devices, are expected to create new investment opportunities [9] - The Chinese government is increasing support for innovative drug exports, as evidenced by recent policies aimed at facilitating the import of research materials for biopharmaceutical companies [9] - Despite market fluctuations due to trade tensions, the pharmaceutical sector remains relatively insulated, presenting a favorable opportunity for large-scale investments [9] Group 5 - The Hong Kong innovative drug sector is poised for a valuation recovery, with significant inflows of capital from southbound investors since the beginning of the year [11] - As of April 24, 2023, net capital inflows from A-share investors into Hong Kong stocks reached 611.1 billion HKD, with healthcare becoming the second most net inflow sector [11] - The current price-to-earnings ratio (TTM) for the pharmaceutical and biotechnology sector is 27.1, indicating that the sector is undervalued compared to other growth sectors [12][13]

Investment Rating - The investment rating for the company is "Buy" (maintained) [7] Core Views - The company has achieved strong positive results in head-to-head trials of its drug, Iwosimab, against Tremelimumab for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC), with significant clinical benefits expected from the upcoming MRCT data readout in mid-2025 [1][2] - The company is well-positioned in the NSCLC market with comprehensive strategies and leading data, anticipating a valuation uplift from global clinical data verification [2][3] - The company is expected to experience significant revenue growth and profitability improvements due to the inclusion of its drugs in medical insurance and the upcoming clinical data readouts [3][4] Financial Summary - Revenue projections for the company are estimated at 3.39 billion, 5.48 billion, and 6.77 billion yuan for 2025, 2026, and 2027 respectively, with net profits expected to be 71 million, 936 million, and 1.605 billion yuan for the same years [4][6] - The earnings per share (EPS) is projected to improve from -0.57 yuan in 2024 to 1.79 yuan in 2027, indicating a strong recovery and growth trajectory [6][4]

消息面上，相关机构近期表示，创新药仍处于产业加速向上的周期，今年也有强基本面的兑现支撑。在 既往ADC、PD1/VEGF等技术爆发之后，TCE、ProTac等新技术已经看到萌芽开花；同时，创新药从可 预期的BD潮走向盈利潮，以往大家对创新药的疑虑是研究壁垒高、企业没盈利，因此不敢投，但随着 未来企业的收入高增速带动利润的快速提升，就进入了投资者可理解的范畴内。 港股创新药板块高盈利持续消化估值。港股创新药指数2月21日市盈率为64倍，4月24日最新市盈率仅为 27倍，不足两个月前的一半，当前布局性价比突出。 4月24日，港股市场低开震荡，港股创新药板块全面爆发。港股创新药指数成分股中，凯莱英涨超 17%，荣昌生物、亚盛医药-B、康方生物涨超7%，信达生物、联邦制药涨超6%，康龙化成、三生制药 涨超4%。港股创新药ETF（159567）连续2个交易日成交额超9亿元，市场关注度较高。 西南证券表示，创新药板块的投资价值在于其背后的新质生产力和高质量发展的大背景。随着各地政府 不断出台支持创新药的政策，如北京、深圳等地发布的支持创新药政策，这些政策不仅加强了对创新药 械研发、生产、审批、使用的全链条支持，还促进了健 ...