今日港股回调，创新药再度逆市上涨！港股通创新药ETF（159570）强势大涨近3%，成交额继续爆量，盘中成交近5亿元！上周五成交额再度刷新历史，天 量成交16.49亿元！资金持续乐观，上周累计获资金净流入近2亿元，今日盘中再获净申购4300万份！ 港股通创新药ETF（159570）成分股多数飘红：乐普生物涨超12%，百济神州涨超5%，信达生物涨超3%，晶泰控股涨超2%，康方生物、药明生物、科伦博 泰生物涨超1%。 资金狂涌创新药，港股通创新药ETF（159570）近60日"吸金"近10亿元，融资余额保持历史高位，反映杠杆资金布局意愿！最新规模19.27亿元创上市新 高，1个月实现规模翻倍！ 【机构：医药见底回暖，创新药主线强化】 光大证券认为，医药行情见底回暖，优化集采政策有望稳定资产盈利能力。近期，医药行情整体已显现见底回暖迹象，从2025.1.2~2025.3.27期间，港股创 新药指数上涨26.28%，跑赢恒生科技1.20pp。2025年工作报告提出"优化药品集采政策"，有望优化产业竞争环境，仿制药利润压缩接近尾声，竞争格局趋于 稳定，龙头白马企业凭借技术壁垒与产能优势，盈利能力有望企稳。后集采时代，行 ...

Core Insights - 康方生物 reported an annual revenue of 2.124 billion RMB for the year ending December 31, 2024, with commercial sales revenue of 2.044 billion RMB, reflecting a year-on-year increase of 25.34% [1] - The company has over 50 innovative projects in development, including 61 self-developed products approved for market and 2 products under NMPA review, with 12 products in Phase III clinical trials and 12 in Phase I/II trials [1] - The company aims to become a leading global biopharmaceutical enterprise through efficient and innovative R&D, production, and commercialization platforms [1] Revenue and Sales Performance - The increase in commercial sales revenue is primarily attributed to the sustained growth in sales of 开坦尼 (卡度尼利, PD-1/CTLA-4) and the positive sales contribution from 依达方 (依沃西, PD-1/VEGF) after its approval in May 2024 [1] - The two products generated significant market demand due to their excellent clinical data and innovative clinical value [1] - The company also received approximately 122 million RMB in commercial licensing income from various product partners, mainly from upfront payments by SUMMIT [1] Production Capacity and Compliance - The company currently has a production capacity of 94,000 liters, ensuring large-scale supply and a stable expansion plan to meet future clinical and commercialization needs [2] - The group's GMP-compliant production facilities are designed and validated according to regulations from the FDA, EMA, and NMPA, supporting the entire drug development process from discovery to commercial production [2]

Financial Performance - For the fiscal year ending December 31, 2024, the total revenue of the company was RMB 2,123.9 million, a decrease of 53.08% compared to RMB 4,526.3 million for the fiscal year ending December 31, 2023[4]. - The company recorded a loss of RMB 501.1 million for the fiscal year ending December 31, 2024, compared to a profit of RMB 1,942.4 million for the fiscal year ending December 31, 2023[6]. - The gross profit for the fiscal year ending December 31, 2024, was RMB 1,834.9 million, down 58.23% from RMB 4,393.0 million in the previous year[5]. - The commercial licensing income for the year ending December 31, 2024, was RMB 121.6 million, a significant decrease from RMB 2,922.8 million for the year ending December 31, 2023[65]. - The total employee compensation cost for the year ending December 31, 2024, was RMB 944.7 million, an increase from RMB 847.1 million for the year ending December 31, 2023, attributed to an increase in employee numbers[85]. - The company reported a net loss of RMB 501,093 thousand for the year ending December 31, 2024, compared to a profit of RMB 1,942,351 thousand in the previous year[103]. Research and Development - The company has over 50 innovative projects under research, with 61 self-developed products approved for market and 12 products undergoing Phase III clinical trials[8]. - Research and development expenses for the year ending December 31, 2024, were RMB 1,187.7 million, a 5.29% decrease from RMB 1,254.0 million for the year ending December 31, 2023, as the company strengthened its clinical team and reduced reliance on external clinical service providers[69]. - The company achieved key milestones in its R&D pipeline, with the global launch of the first-in-class bispecific antibody Iwoshib (PD–1/VEGF) approved in May 2024, and multiple new lines receiving IND approval, including AK135 (IL–1RAP biologic) and AK138D1 (HER3 ADC)[70]. - The company is focusing on tumor immunotherapy, with several products in clinical trials, including approved drugs like Ketanil® and Yidafang®[48]. Product Development and Clinical Trials - Cardunili's sNDA for first-line treatment of cervical cancer is in the final review stage at NMPA, with III phase clinical trial results presented at the 2024 IGCS global conference[14]. - Yidafang® (Ivosidenib, PD-1/VEGF) has been deployed in 18 indications with over 27 clinical trials, including 12 III phase trials covering various cancers[18]. - The Phase III clinical trial for the combination therapy of Ivoris in treating pancreatic cancer is underway, demonstrating superior efficacy and safety, establishing its potential as a cornerstone in tumor immunotherapy[25]. - The III phase clinical trial results for Yidafang® were published at the 2024 ASCO conference and included in major treatment guidelines[21]. - The company has successfully developed Tetrabody technology to overcome challenges in the development and production of bispecific antibodies[7]. Market Strategy and Commercialization - The company expects to become a leading global biopharmaceutical enterprise through efficient and innovative research, development, and commercialization platforms[8]. - The commercial system has undergone a comprehensive upgrade, focusing on a "patient-centric" approach to achieve rapid market entry and growth[58]. - The company aims to leverage its foundational drugs Ketanil® and Yidafang® to cover a broader market space through extensive combination therapies[48]. - The company anticipates significant market demand for its products due to excellent clinical data and innovative clinical value[9]. Financial Position and Assets - As of December 31, 2024, the group's current assets amounted to RMB 8,691.6 million, with cash and cash equivalents, time deposits, and financial products totaling RMB 7,343.9 million, an increase of RMB 2,449.4 million from RMB 4,894.4 million as of December 31, 2023[76]. - The group's current liabilities as of December 31, 2024, were RMB 1,686.6 million, including trade payables of RMB 425.2 million and other payables of RMB 715.1 million[77]. - The total assets minus current liabilities amounted to RMB 11,068,335,000 in 2024, up from RMB 7,976,508,000 in 2023, indicating an increase of approximately 38.5%[105]. - The company reported cash and cash equivalents of RMB 6,918,065,000 in 2024, compared to RMB 4,041,986,000 in 2023, reflecting a growth of about 71.2%[105]. Corporate Governance and Compliance - The company has complied with all applicable corporate governance codes during the reporting period, except for C.2.1[90]. - The audit committee has been established to assist the board in providing independent opinions on financial reporting processes and internal controls[98]. - The company plans to continue reviewing and monitoring its corporate governance practices[92]. - The chairman and CEO roles are currently held by the same individual, which the board believes provides strong and consistent leadership[91].

Group 1 - The Hang Seng Healthcare Index (HSHCI) has seen a strong increase of 1.80%, with notable gains from companies such as Lepu Biopharma-B (up 16.56%) and Zai Lab (up 10.27%) [1] - The Hang Seng Medical ETF (513060) has risen by 2.11%, marking its third consecutive increase, with a trading volume of 4.69 billion yuan [1][2] - The second Boao Lecheng Stem Cell Conference has opened, marking a new phase of standardized and high-quality development in China's stem cell industry [2] Group 2 - Financial analysts predict that the approval and implementation of more projects in the stem cell sector will lead to advanced treatment methods benefiting the public [2] - The domestic medical innovation industry is expected to experience multiple growth opportunities, particularly for companies with true innovation capabilities in new drug development [2] - The Hang Seng Medical ETF has seen a significant growth in scale, increasing by 34.09 billion yuan over the past year, ranking in the top third among comparable funds [2] Group 3 - Since its inception, the Hang Seng Medical ETF has achieved a maximum monthly return of 28.34% and an average monthly return of 7.00% [3] - The ETF has outperformed its benchmark with an annualized excess return of 2.02% over the past year [3] - The ETF's management fee is 0.50%, and the custody fee is 0.15% [3] Group 4 - The tracking error of the Hang Seng Medical ETF is 0.033%, the highest tracking precision among comparable funds [4] - The latest price-to-earnings ratio (PE-TTM) of the Hang Seng Medical Healthcare Index is 24.97, indicating it is at a historical low compared to the past year [4] - The top ten weighted stocks in the Hang Seng Medical Healthcare Index account for 55.64% of the index, with companies like WuXi Biologics and BeiGene among the leaders [4][6]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical industry [7] Core Insights - The report emphasizes the leadership of Chinese companies in the PD-(L)1 bispecific antibody sector, highlighting it as a representative technology platform for new drug development in China [21][13] - The overall performance of the pharmaceutical sector has shown a 1.77% increase, outperforming both the ChiNext Index and the CSI 300 Index during the week of March 10-14 [13][14] Summary by Sections Recent Performance - The market experienced an upward trend with a notable surge on Friday, reflecting a shift from technology to non-technology sectors, particularly in consumer healthcare and policies related to the three-child policy [2][14] - The report notes that while innovative drugs and AI healthcare showed signs of correction, other themes such as consumer healthcare and small-cap innovations in Hong Kong gained traction [2][14] Future Outlook - In the short to medium term, the focus is on identifying opportunities in consumer healthcare, particularly those with attributes appealing to children and those positioned for consumption upgrades [15] - For 2025, the report anticipates improvements in the pharmaceutical payment sector due to supportive policies for commercial health insurance, indicating a gradual accumulation of positive changes [15] Strategic Allocation Thoughts - The report outlines two main strategies for investment: 1. **Pharmaceutical Style Rhythm**: Focus on consumer healthcare companies like Angelalign and Aier Eye Hospital, and innovative drug companies such as Innovent Biologics and BeiGene [16] 2. **Pharmaceutical Industry Logic**: Emphasizes the commercialization of innovative drugs and the integration of new technologies, with a focus on companies like CStone Pharmaceuticals and Zymeworks [17][19] Key Companies to Watch - The report suggests monitoring companies involved in PD-(L)1 bispecific antibodies, including CanSino Biologics, Innovent Biologics, and I-Mab Biopharma, as they are positioned at the forefront of clinical advancements [21][34]

Investment Rating - The report maintains a "Buy" rating for 康方生物 (9926 HK) with a target price of 87 HKD, indicating a potential upside of 26.7% from the current price of 68.65 HKD [4][5]. Core Insights - 康方生物 has entered a clinical trial collaboration with Pfizer to explore the potential of combining its PD-1/VEGF dual antibody, 依沃西, with multiple vedotin ADCs from Pfizer for treating various solid tumors. The clinical trials are expected to start in mid-2025, primarily focusing on Phase Ib/II studies [1][3]. - The collaboration is significant as Pfizer has a robust pipeline of vedotin ADCs, which have shown promising preliminary clinical results when combined with PD-1 targeted therapies, suggesting a synergistic anti-tumor effect [2][3]. - 康方生物 is also advancing its clinical trials in multiple indications, including biliary cancer, head and neck squamous cell carcinoma, pancreatic cancer, and triple-negative breast cancer, with several key catalysts expected in 2025 [3]. Summary by Sections - **Clinical Collaboration**: 康方生物's partnership with Pfizer aims to leverage the strengths of both companies in developing innovative cancer therapies, with a focus on the efficacy of 依沃西 in combination with vedotin ADCs [1][3]. - **Pipeline and Milestones**: Key milestones for 康方生物 in 2025 include the readout of the HARMONi trial for EGFR TKI-treated NSCLC, the initiation of the ADC combination trials, and ongoing patient enrollment in important Phase III studies [3]. - **Market Position**: 康方生物 is positioned as a key player in the oncology sector, with a strong emphasis on expanding its clinical development efforts and maintaining a competitive edge in the market [3].

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 87.00, indicating a potential upside of 45.9% from the current price of HKD 59.65 [1][6][12]. Core Insights - The company has recently submitted its third non-oncology product for market approval and has initiated multiple Phase III trials for its product, Ivoris, in various indications beyond lung cancer, reaffirming the "Buy" rating [2][6]. - The financial forecasts have been adjusted, reflecting a more cautious short-term sales outlook, but the long-term peak sales estimates for key products have been maintained or increased [6][7]. Financial Overview - Revenue projections for 2024, 2025, and 2026 are revised to RMB 2,411 million, RMB 4,096 million, and RMB 5,861 million respectively, with significant growth expected in the following years [5][14]. - The net profit is expected to improve from a loss of RMB 509 million in 2024 to a profit of RMB 595 million in 2025, and further to RMB 1,707 million in 2026 [5][14]. - The company’s market capitalization is approximately HKD 53.42 billion, with a 52-week high of HKD 77.55 and a low of HKD 31.80 [4][6]. Product Development - The company has successfully submitted its eighth innovative drug application, targeting moderate to severe plaque psoriasis, enhancing its product portfolio in the autoimmune field [6][7]. - The ongoing Phase III studies for Ivoris in various cancers are expected to expand its market opportunities significantly, particularly in indications with limited current treatment options [6][7]. Valuation Model - The DCF valuation model estimates the equity value at approximately RMB 70,990 million, translating to a per-share value of HKD 87.00 [8].

Investment Rating - The report maintains a "Buy" rating for the company [1] Core Views - Ivonescimab (依沃西单抗) demonstrated significant therapeutic benefits in multiple clinical trials, particularly in the HARMONi-2 study where it outperformed pembrolizumab (帕博利珠单抗), showcasing its potential as a global blockbuster [1] - The overseas expansion of Ivonescimab is expected to enhance its revenue peak and company valuation [1] - The company's mature pipeline, including cadonilimab (卡度尼利单抗) and inusirumab (伊努西单抗), is progressing steadily towards commercialization, with new indications and market potential [4] Clinical Results - In the HARMONi-2 study, Ivonescimab showed a significant PFS advantage over pembrolizumab (11.14 vs 5.82 months, HR=0.51) and demonstrated excellent safety with low rates of TRAE-related discontinuation and mortality (1.5% and 0.5%) [2] - Ivonescimab also showed promising efficacy in NSCLC perioperative treatment, head and neck squamous cell carcinoma, colorectal cancer, and TNBC in Phase II trials [2] Overseas Expansion - Ivonescimab's overseas Phase III trials, HARMONi and HARMONi-3, are progressing, with HARMONi-3 expanding its target population to include both squamous and non-squamous NSCLC [3] - The HARMONi-7 study targeting PD-L1 strong-positive NSCLC patients is set to begin in early 2025, further enhancing Ivonescimab's global potential [3] Other Pipelines - Cadonilimab has seen new indications approved and has been included in the national medical insurance, boosting its commercialization potential [4] - Inusirumab, a PCSK9 monoclonal antibody, was approved in September, and other non-oncology drugs are expected to be launched within the next three years [4] Market Differentiation - The report differs from market consensus by expressing strong confidence in the company's overseas potential, citing the robust data from the HARMONi-2 study and the likelihood of replicating domestic success in international markets [5] Financial Forecasts and Valuation - Revenue forecasts for 2024/2025/2026 have been revised downward to 2.312/3.342/5.409 billion RMB (down 13.0/20.8/14.0% from previous estimates) due to national negotiations and the approval pace of non-oncology drugs [6] - The DCF terminal value has been increased from 36 billion to 65.2 billion RMB, leading to a target market cap of 84.5 billion RMB and a target price of 100.45 HKD [6] Industry Insights - The report highlights the potential of IO (immuno-oncology) combined with anti-angiogenesis therapies, noting that while some combinations have shown promise, others have failed due to toxicity and efficacy issues [27][28] - The LEAP series of studies, which explored the combination of pembrolizumab and lenvatinib, showed mixed results, with some studies achieving positive outcomes while others failed to meet OS endpoints [29][30][31]

Investment Rating - The report assigns a **Buy** rating to the company with a target price of **HKD 77.7**, representing a **19% upside** from the current price of HKD 65.2 [5] Core Views - The company's R&D pipeline demonstrates **world-class potential**, particularly with its key products **AK104 (PD-1/CTLA-4)** and **AK112 (PD-1/VEGF)**, which have shown significant clinical progress and market potential [2][3] - The company's revenue in H1 2024 increased by **24% YoY to RMB 940 million**, driven by strong sales of **AK104 (RMB 710 million, +16.5% YoY)** and **AK105 (RMB 130 million)** [2] - Despite a net loss of **RMB 240 million** in H1 2024, the company maintains a strong cash position of **RMB 2.4 billion**, supported by two successful placements in 2024 raising **HKD 1.17 billion** and **HKD 1.92 billion** respectively [2] Product Pipeline Summary AK104 (PD-1/CTLA-4) - Achieved **PFS (12.7 vs 8.1 months, HR 0.62)** and **OS (not reached vs 22.8 months, HR 0.64)** endpoints in **first-line cervical cancer**, with significant efficacy across all populations, including **PD-L1 low/negative expression** (CPS <1, 23% reduction in death risk) [3] - Approved for **first-line gastric cancer** in October 2024, showing **OS benefit (15 vs 10.8 months, HR 0.62)**, addressing the unmet need in **PD-L1 low/negative gastric cancer** (mOS 17.6 months vs 11 months for PD-1) [3] - Multiple **Phase III trials** ongoing for **gastric cancer post-PD-(L)1 progression**, **hepatocellular carcinoma**, and **non-small cell lung cancer (NSCLC)** [3] AK112 (PD-1/VEGF) - Approved in May 2024 for **EGFR-mutated NSCLC post-treatment progression**, with **Summit global Phase III** trial completed and **FDA Fast Track** designation [3] - Achieved **PFS endpoint (11.14 vs 5.82 months, HR 0.51)** in **first-line PD-L1-positive NSCLC** vs **Pembrolizumab**, with **NDA submitted** in July 2024 [3] - Expanded **Summit Phase III** trial to include **non-squamous NSCLC** with a sample size of **1,080 patients**, alongside ongoing trials for **biliary tract cancer**, **pancreatic cancer**, and **head and neck squamous cell carcinoma** [3] Other Key Products - **AK105 (PD-1)**: Under review for **first-line nasopharyngeal carcinoma** and submitted for **first-line hepatocellular carcinoma** [3] - **AK102 (PCSK9)**: Approved in October 2024 [3] - **AK101 (IL-12/IL-23)**: Submitted for **moderate-to-severe plaque psoriasis** in August 2023 [3] - **AK111 (IL-17)**: Completed Phase III enrollment for **psoriasis** and ongoing for **ankylosing spondylitis** [3] - **AK117 (CD47)**: Global first **Phase III** trial for **solid tumors** [3] Financial Summary - Revenue for 2024E is projected at **RMB 2.5 billion**, with a **32.6% YoY growth** expected in 2025E to **RMB 3.3 billion** [4] - Gross margin remains strong at **91.3%** in H1 2024, with **R&D expenses** increasing by **3% to RMB 590 million** [2] - Net loss for 2024E is estimated at **RMB 184 million**, with a turnaround to **RMB 775 million net profit** expected in 2026E [4] Valuation - The target price of **HKD 77.7** is derived using a **DCF model** with a **WACC of 10.0%** and **perpetual growth rate of 3.0%**, incorporating **AK112's overseas potential** (USD 6 billion sales, 60% success probability) [3]

Investment Rating - The report maintains a "Buy" rating for the company Kangfang Biopharma (09926) [6] Core Insights - Kangfang Biopharma is positioned as a leader in bispecific antibody therapies, successfully challenging established treatments and advancing its internationalization efforts [4][23] - The company has achieved significant clinical trial results, particularly with its product AK112, which has shown promising outcomes against existing therapies in lung cancer treatment [4][6] - The financial outlook is positive, with projected revenues increasing significantly over the next few years, leading to expected profitability by 2025 [6][11] Summary by Sections Company Overview - Kangfang Biopharma focuses on developing innovative and affordable antibody drugs, leveraging a unique end-to-end research and development platform [23] - The company has established a strong pipeline of products, with several in late-stage clinical trials and some already approved for market [23][24] Industry Situation - The tumor immunotherapy market is rapidly growing, with bispecific antibodies playing a crucial role in the evolution of cancer treatment [11][23] - The report highlights the limitations of current T-cell targeting immunotherapies and the potential of bispecific antibodies to address these challenges [11] Company Highlights - AK112 has demonstrated breakthrough results in clinical trials, positioning it as a potential new standard for first-line treatment in lung cancer [4][6] - The company’s product AK104 has also shown significant efficacy in treating advanced cervical cancer, filling a gap in the current treatment landscape [5][6] Financial Forecast and Valuation - Projected revenues for 2024, 2025, and 2026 are estimated at 26.78 billion, 43.33 billion, and 69.78 billion yuan respectively, with a return to profitability expected in 2025 [6][11] - A DCF valuation model suggests a reasonable market capitalization of 754.15 billion HKD, corresponding to a target price of 84.15 HKD per share [6]