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]

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 report maintains a "Buy" rating for Zai Lab (ZLAB) with a 12-month price target of $53.91, indicating an upside potential of 82.5% from the current price of $29.54 [10][11]. Core Insights - The competitive landscape for generalized Myasthenia Gravis (gMG) treatment is evolving, particularly with the positive Phase 3 results of telitacicept, which has implications for Zai Lab's efgartigimod [1]. - Efgar's competitive profile is highlighted by its quick treatment onset and durable symptom improvement, making it a favorable option for refractory gMG patients [1][4]. - Zai Lab is transitioning from a licensing-in model focused on China to a dual engine model that includes in-house development and global opportunities, which is expected to enhance its R&D progress [9]. Summary by Sections Competitive Landscape - The report discusses the competitive dynamics in gMG treatment, noting that while telitacicept shows deep patient response, efgar demonstrates quicker symptom relief, which is crucial for patient adoption [4][8]. - The treatment duration is a significant differentiator, with efgar accumulating clinical evidence for long-term usage, while RC18 is positioned as a long-term maintenance therapy [4][5]. Clinical Data Comparison - Efgar shows a mean change of -5.13 in MG-ADL score at week 21, compared to RC18's -5.74 at week 24, indicating efgar's quicker onset of symptom improvement [9]. - The report emphasizes the variability in placebo profiles across clinical trials, suggesting caution in cross-trial comparisons [8]. Market Position and Future Outlook - Zai Lab's efgar is positioned favorably due to its two-year lead in NRDL coverage and endorsements from clinical guidelines in both China and the US [8]. - The report anticipates that Zai Lab's global pipeline will attract more market interest starting in 2025, as the company becomes more selective in its licensing deals [9].

Core Viewpoint - CICC maintains its earnings forecast for Zai Ding Pharmaceutical (09688) for 2025 and 2026, with a target price of HKD 34.41/USD 44.24 based on DCF model, and continues to rate it as outperforming the industry [1] Group 1: Product Approval and Administration - The FDA has approved the subcutaneous pre-filled injection of Efgartigimod, which can be administered by patients, caregivers, or healthcare professionals, taking 20-30 seconds per injection [2] - Efgartigimod's approval is based on its bioequivalence to the vial formulation, and the company plans to submit a domestic application for the pre-filled injection by 2025 [2] Group 2: Efgartigimod's Efficacy - Efgartigimod is considered the best therapy for gMG, with a cumulative achievement rate of 40%-73% for minimal symptom expression (MG-ADL ≤ 1), significantly outperforming competitors [3] - The drug shows rapid onset of action, with significant improvement in ADL within the first week and a 73.0% improvement by week four [3] - Long-term efficacy is supported by a three-year follow-up study (ADAPT+), demonstrating sustained effectiveness with a controlled infection risk and a serious adverse event rate of 4.8% [3] Group 3: Upcoming Catalysts and Product Developments - The company has a rich pipeline with several key products expected to report critical data, including ZL-1310 (DLL3 ADC) with positive ORR data expected in 1H25 [4] - Bemarituzumab (FGFR2b) is anticipated to report clinical data from the global Phase III FORTITUDE-101 study in 1H25, followed by a domestic NDA submission [4] - KarXT has received FDA approval, with its domestic application accepted in January 2025, and results for the global Phase III data for ADP are expected in 2H25 [4] - The company plans to submit domestic applications for tumor electric field therapy for pancreatic cancer and non-small cell lung cancer by 2025 [4]

Core Insights - The recent AAN annual meeting showcased significant advancements in the treatment of Myasthenia Gravis (MG), particularly with new targeted biologics entering the market, indicating a shift in the competitive landscape for MG therapies [1] Competitive Landscape in gMG Treatment - The report from Goldman Sachs highlights the positive clinical data from Rongchang Biopharma's dual-target biologic RC18, which has shown deep patient response capabilities, sparking discussions on its efficacy compared to FcRn antagonists like Efgartigimod [2] - FcRn class drugs, including Efgartigimod, are expected to have a speed advantage in onset of action due to their mechanism of action, which could provide a competitive edge in the market [2] - Efgartigimod demonstrated a 4.6-point reduction in MG-ADL scores by week 4, more than double the efficacy of RC18 at the same time point, highlighting the importance of rapid onset in treating acute and refractory patients [2] Maintenance Therapy as a Future Focus - As MG is a chronic disease requiring long-term management, maintenance therapy is anticipated to become a key competitive focus in the MG drug market [4] - Efgartigimod currently employs an intermittent treatment model of "4 weeks on + 3 weeks off," but is exploring a more flexible bi-weekly maintenance treatment option, showing good safety and sustained efficacy in clinical data [4] External Factors Influencing Competition - The report emphasizes that factors beyond clinical data, such as insurance coverage, will significantly impact the competitive landscape for gMG treatments [5] - Efgartigimod has been included in China's National Reimbursement Drug List (NRDL) since 2023, while RC18 is not expected to gain reimbursement coverage until 2026, providing Efgartigimod with at least a two-year market lead [5] Administration Method Diversity - Efgartigimod's recently FDA-approved pre-filled subcutaneous injection allows for self-administration, enhancing convenience for patients, while RC18 is limited to subcutaneous injection [7] - Efgartigimod is widely recommended in treatment guidelines in both the US and China, enhancing its brand value and trust among healthcare providers and patients [7] Overall Competitive Advantage - Despite RC18's strong efficacy, Efgartigimod's rapid onset, flexible treatment options, and market lead position it favorably in the gMG treatment landscape [7]

港股医药股持续走弱，歌礼制药(01672.HK)跌超12%，药明生物(02269.HK)跌超5%，再鼎医药 (09688.HK)、昭衍新药(06127.HK)等跟跌。 ...

Investment Rating - The report maintains a "Buy" rating for Zai Lab (09688.HK) [2] Core Views - Zai Lab's drug Efgartigimod shows strong potential in the treatment of Myasthenia Gravis (MG) with rapid onset and long-term efficacy, establishing its position as a Best-in-Class (BIC) therapy [8][11] - The FDA has approved the pre-filled subcutaneous injection form of Efgartigimod, enhancing its competitive edge in the market [25][26] - The company is expected to achieve significant revenue growth, with projected revenues of $564 million in 2025 and $1.357 billion in 2027, reflecting growth rates of 41.35% and 62.46% respectively [7][40] Summary by Sections Market Performance - Zai Lab's stock price is currently at HKD 22.20, with a market capitalization of HKD 24.45 billion [2][7] Financial Data and Forecast - Total shares outstanding: 1,101.28 million - Revenue projections: $267 million in 2023, $399 million in 2024, $564 million in 2025, $835 million in 2026, and $1.357 billion in 2027 - Net profit projections: -$335 million in 2023, -$257 million in 2024, -$166 million in 2025, $17 million in 2026, and $168 million in 2027 - Gross margin expected to improve from 62.94% in 2024 to 69.45% in 2027 [7][40] Drug Development Insights - Efgartigimod has shown rapid efficacy in clinical trials, with 40% of patients achieving minimal symptom expression (MSE) within the first treatment cycle [8][14] - Long-term studies indicate consistent efficacy and safety, with 89% of patients showing significant improvement after 11 treatment cycles [21][22] - The drug is positioned to treat multiple autoimmune diseases, expanding its market potential beyond MG [37][32] Competitive Landscape - Despite the emergence of several competing biologics in the MG treatment space, Efgartigimod's sales growth remains robust, with projected global sales of approximately $2.2 billion in 2024 [32][34]

[Table_Main] 证券研究报告 | 公司点评 再鼎医药(09688.HK) 2025 年 04 月 14 日 买入（维持） 所属行业：医疗保健业/药品及生物科技 当前价格(港币)：22.20 元 证券分析师 周新明 资格编号：S0120524060001 邮箱：zhouxm＠tebon.com.cn 李霁阳 资格编号：S0120523080003 邮箱：lijy7＠tebon.com.cn 市场表现 -31% 0% 31% 63% 94% 126% 157% 188% 2024-04 2024-08 2024-12 再鼎医药 恒生指数 | 恒 生 指 数 对 | 1M | 2M | 3M | | --- | --- | --- | --- | | 比 | | | | | 绝对涨幅(%) | -18.83 | 5.21 | 17.34 | | 相对涨幅(%) | -7.45 | 9.53 | 7.63 | | 资料来源：德邦研究所，聚源数据 | | | | 重症肌无力领域近期新药进展众多，我们认为艾加莫德作为 BIC，在 MG 治疗领 域地位难以被撼动。 1）快速起效，快速达标：越来越多的临床试验使用基 ...

相关ETF方面，截至发稿，港股创新药ETF（159567）高开高走，现涨5%。成分股中，再鼎医药涨超 14%，药明合联、科伦博泰生物-B、东阳光长江药业、荣昌生物等涨幅居前。 4月14日，港股集体高开，创新药板块涨幅居前。 消息面上，Wind金融终端数据显示，截至4月13日，已有超过230家生物医药行业上市公司披露了2024 年度经营数据（含年报、业绩快报）。其中，25家公司营收突破百亿元大关，上海医药以2752.51亿元 的营收一骑绝尘；有近半数企业盈利能力持续上升，26家公司归母净利润超过10亿元，药明康德以94.5 亿元的归母净利润领跑行业；超过半数的企业研发投入持续增长，其中百济神州全年研发费用高达 19.53亿美元（约合人民币142.79亿元），同比增长9.8%，占营收比例约为52%。 广发证券表示，建议重视港股创新药的配置价值，原因在于：首先，中国创新药出海的全球竞争优势正 在凸显。近年来，中国药企在海外市场的License-out交易实现了跨越式发展，展现出中国创新药研发的 全球竞争力。NewCo模式的兴起，进一步为原药企解决了融资难、变现难、研发风险大等问题。其 次，当前关税政策对创新药影响远 ...

Group 1 - The Hang Seng Healthcare Index (HSHCI) has seen a strong increase of 2.95%, with notable gains from companies such as Zai Lab (09688) up 12.39% and Dongyangguang Changjiang Pharmaceutical (01558) up 9.04% [3] - The Hang Seng Healthcare ETF (513060) has risen by 3.15%, marking its fourth consecutive increase, with a recent price of 0.46 yuan [3] - Over the past three months, the Hang Seng Healthcare ETF has accumulated a total increase of 21.98% [3] Group 2 - The Hang Seng Healthcare ETF has experienced a net value increase of 26.66% over the past year, with the highest single-month return reaching 28.34% since its inception [4] - The ETF's Sharpe ratio stands at 1.27, indicating strong risk-adjusted returns [4] - The ETF's management fee is 0.50%, and the custody fee is 0.15% [4] Group 3 - The top ten weighted stocks in the Hang Seng Healthcare Index account for 56.37% of the index, with companies like BeiGene (06160) and WuXi Biologics (02269) leading the list [5] - The performance of these stocks varies, with BeiGene showing a gain of 5.34% and WuXi Biologics up by 2.81% [7] Group 4 - The current market environment emphasizes the importance of domestic consumption growth due to pressures from U.S.-China tariffs, highlighting healthcare consumption as a key investment area [8] - The market sentiment is recovering, with a focus on undervalued blue-chip stocks and companies with solid fundamentals, particularly in the healthcare sector [8]