港股医药股走低 康方生物跌超15% 智通财经4月28日电，截至发稿，康方生物(09926.HK)跌15.07%、宜明昂科-B(01541.HK)跌9.75%、再鼎 医药(09688.HK)跌6.43%、加科思-B(01167.HK)跌5.37%、腾盛博药-B(02137.HK)跌5%。 ...

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]

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]

Investment Rating - The investment rating for the company is "Buy" with a target price of HKD 115.25 [8][5]. Core Views - The mid-term analysis of AK112-306 shows strong positive results, marking the second head-to-head positive outcome for the drug in the NSCLC field, indicating a promising future for the drug in lung cancer treatment [1][2]. - The drug has demonstrated significant benefits in first-line sqNSCLC patients, regardless of PD-L1 expression, with a notable safety profile [2][3]. - The company is expected to accelerate its global clinical trials, with positive results from AK112-306 likely to expedite the HARMONi-3 study [3][4]. - The company anticipates that the application for the drug's approval for 1L PD-L1 positive NSCLC in China will be submitted soon, with multiple ongoing Phase III trials for other indications [4][5]. Financial Projections and Valuation - The company has adjusted its net profit forecasts for 2025-2027 to RMB 0.76 billion, RMB 6.62 billion, and RMB 14.16 billion, respectively, reflecting an increase in the success rate of developing the 1L PD-L1 negative NSCLC indication [5][13]. - The projected revenue for 2025 is RMB 3.35 billion, with a significant increase expected in subsequent years [20][21]. - The DCF valuation method estimates the company's fair value at approximately RMB 970 billion, with a target price adjustment to HKD 115.25 [5][13].

Core Viewpoint - The head-to-head trial results of Iwosimab (PD-1/VEGF dual antibody) against the PD-1 therapy from BeiGene demonstrate significant clinical benefits, marking a milestone in the treatment of squamous non-small cell lung cancer (sq-NSCLC) [1][2][3] Group 1: Clinical Trial Results - Iwosimab combined with chemotherapy showed strong positive results compared to BeiGene's Tislelizumab combined with chemotherapy in a pivotal Phase III trial (AK112-306/HARMONi-6) for advanced sq-NSCLC [1] - The trial results indicate statistically significant benefits and major clinical advantages, which are expected to enhance treatment options for sq-NSCLC patients [2][3] - Iwosimab has previously demonstrated a doubling of median progression-free survival (mPFS) in a head-to-head trial against Merck's Keytruda (Pembrolizumab) [2] Group 2: Market Impact and Company Performance - Following the announcement of the trial results, Kangfang Biopharma's stock surged over 10%, reaching a historical high of 100 HKD per share, with a cumulative increase of over 40% in recent times [2] - The sales figures for Tislelizumab are projected to be 3.806 billion CNY in 2023 and 4.467 billion CNY in 2024, indicating its status as a leading domestic PD-1 therapy [2] Group 3: Industry Trends and Innovations - The Chinese innovative drug sector is increasingly taking the lead in lung cancer treatment, with a notable shift from "follower" to "leader" status in various therapeutic areas [6] - The latest National Medical Insurance directory includes 12 new drugs for lung cancer treatment, reflecting the growing innovation in the Chinese pharmaceutical industry [6] - The overall five-year survival rate for late-stage lung cancer patients in China has improved from 5% during the chemotherapy era to 20%-30% currently, although it still lags behind the overall cancer survival rate of 43% [6] Group 4: Future Prospects - Kangfang Biopharma is expected to release international multi-center Phase III clinical data for Iwosimab in 2025, which could lead to a submission for FDA approval if results are positive [8] - The company emphasizes the importance of head-to-head trials to establish the clinical value of new therapies against existing standards [4][5]

Investment Rating - The report assigns a "Buy" rating to the company 康方生物 (9926 HK) with a target price of HKD 115.00, indicating a potential upside of 30.1% from the current price of HKD 88.40 [1][7][13]. Core Insights - The success of the second head-to-head Phase III trial for the drug 依沃西 (Ivosidenib) has validated its competitive advantage in the lung cancer treatment market compared to PD-(L)1 monotherapy. The trial achieved significant benefits in progression-free survival (PFS) [7]. - The company has received approval for its first autoimmune product, 依若奇单抗 (Ilumya), which is expected to generate peak sales of approximately RMB 1 billion due to its advantages over competitors in treating moderate to severe plaque psoriasis [7]. - The revenue forecasts for 2025-2027 have been adjusted upwards by 0-6%, with peak sales estimates for 依沃西 in mainland China and overseas raised to RMB 6.1 billion and USD 5.7 billion, respectively [7]. Financial Overview - Revenue projections for 康方生物 are as follows: RMB 4,095 million in 2025, RMB 6,091 million in 2026, and RMB 8,680 million in 2027, reflecting growth rates of 92.8%, 48.8%, and 42.5% respectively [6][15]. - The net profit is expected to recover from a loss of RMB 446 million in 2024 to RMB 629 million in 2025, and further increase to RMB 1,982 million in 2026 and RMB 3,557 million in 2027 [6][15]. - The company’s market capitalization is approximately HKD 79.17 billion, with a year-to-date stock price increase of 45.63% [4][6]. Valuation Metrics - The price-to-earnings (P/E) ratio is projected to be 112.8x in 2025, decreasing to 35.8x in 2026 and further to 19.9x in 2027, indicating improving profitability [6][8]. - The book value per share is expected to rise from RMB 5.58 in 2023 to RMB 14.58 in 2027, with a corresponding decrease in the price-to-book (P/B) ratio from 14.94x to 5.72x [6][8].

Core Insights - The article discusses the positive results of a Phase III clinical trial (AK112-306/HARMONi-6) for the dual-specific antibody drug Iwosimab (PD-1/VEGF) in treating advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2] - The trial demonstrated a statistically significant improvement in progression-free survival (PFS) compared to the control group, indicating a major clinical benefit [1][2] - Iwosimab is positioned to become a new standard treatment option in the NSCLC field, enhancing the clinical benefits of immunotherapy [2] Group 1: Clinical Trial Results - The HARMONi-6 trial included 532 participants, with approximately 63% having central squamous cell carcinoma, aligning with real-world patient distribution [1][2] - In the intention-to-treat population, the Iwosimab plus chemotherapy group showed a decisive positive result in PFS compared to the control group [1] - The safety profile of Iwosimab was favorable, with no new safety signals identified, and the incidence of treatment-related severe adverse events was similar to the control group [1] Group 2: Drug Development and Market Position - Iwosimab is the first PD-1/VEGF dual-specific tumor immunotherapy drug developed by the company, expected to receive NMPA approval for use in advanced EGFR-mutant NSCLC by May 2024 [3] - The drug is currently involved in 12 ongoing Phase III clinical trials, including three international multi-center studies [3] - Iwosimab is being tested for a total of 18 indications, covering various cancers such as lung cancer, biliary cancer, head and neck squamous cancer, triple-negative breast cancer, colorectal cancer, pancreatic cancer, and hepatocellular carcinoma [3]