机构：申万宏源研究 研究员：周文远/胡梦婷 风险提示：关键在研产品研发失败；核心产品商业化进度低于预期 康方生物2025 年上半年收入同比增长37.8%，达到14.1 亿元，归属于股东的净亏损为5.70亿元，符合我 们的预期。2025 年上半年，公司产品净收入同比增长49.2%至14.0 亿元，主要由于卡度尼利和依沃西纳 入医保后销售放量。上半年，公司研发费用同比增长23.0%至7.31亿元，销售费用同比增长29.8%至6.70 亿元。截至2025 年6 月底，公司现金储备约为71.4亿元。 依沃西HARMONi-A 达到OS 终点。目前，AK112 首个适应症已被纳入医保，用于治疗EGFR-TKI 治疗 后进展的EGFR 突变非鳞状NSCLC 患者。2025 年8 月，公司宣布该临床试验的OS 最终分析显示AK112 达到OS 临床终点，取得具有统计学显著和临床意义显著的OS获益。第二项适应症为一线治疗PD-L1 表 达阳性的NSCLC，已于今年4 月获得NMPA 批准上市。同时，AK112 第三项适应症申报，针对一线治 疗鳞状NSCLC 的上市申请正在NMPA审评中，详细数据有望于2025 年下半年的国际 ...

上 市 公 司 2025 年 09 月 02 日 康方生物 (09926) ——商业化持续推进，HARMONi-A 达到 OS 终点 报告原因：有业绩公布需要点评 | 市场数据： | 2025 年 08 月 29 日 | | --- | --- | | 收盘价（港币） | 155.70 | | 恒生中国企业指数 | 8947.79 | | 52 周最高/最低（港币） | 179.00/47.70 | | H 股市值（亿港币） | 1,397.55 | | 流通 H 股（百万股） | 897.59 | | 汇率（人民币/港币） | 1.0970 | 一年内股价与基准指数对比走势： 医药生物 买入（维持） 研究支持 胡梦婷 A0230524060004 humt@swsresearch.com 联系人 《Akeso, Inc.(09926):Sales ramp-up of key products after the NRDL inclusion》 2025/04/08 胡梦婷 (8621)23297818× humt@swsresearch.com 财务数据及盈利预测 证券分析师 -5% 95% 195% 2 ...

Core Insights - Kangfang Biopharma is a global leader in bispecific antibodies, with its core product, AK112 (PD-1/VEGF bispecific antibody), becoming the first bispecific antibody to surpass Keytruda in mPFS for first-line lung cancer treatment [1] - The report updates on AK112's clinical data both domestically and internationally, highlighting its potential as a blockbuster drug, and discusses the differentiation between AK104 and AK112 [1][2] - Future focus areas include the 2025 ESMO HARMONi-6 clinical data release, overseas clinical progress for AK112 and AK104, domestic healthcare negotiations in 2025, and potential business development opportunities [1] Commercialization Capability - Both Kadunili and AK112 have been included in healthcare insurance, with Kadunili achieving sales of 546 million yuan in its first year and 1.358 billion yuan in 2023, representing a growth of 148.5% [2] - AK112 generated approximately 350 million yuan in its first year post-launch, with the negotiated price dropping to 736 yuan per bottle, a reduction of 68% [2] - The overseas development of AK112 is supported by a $5 billion licensing agreement with Summit Therapeutics, which is conducting three ongoing Phase III clinical trials [2] R&D Pipeline - The company has over 50 innovative drug candidates targeting major diseases, with 24 new drugs in clinical research and commercialization stages, including 15 potential first-in-class or best-in-class bispecific antibodies [2] - 17 Phase III clinical trials are currently underway, including PD-1/LAG-3 bispecific antibody AK129 and TIGIT/TGF-β fusion protein AK130 [2] - The exploration of new therapeutic approaches through bispecific antibodies and ADCs is expected to become a second growth point for the company [2] Company Catalysts - Upcoming catalysts include the Phase III HARMONi-6 study data readout for AK112 at the ESMO conference in October, and potential updates on HARMONi-3 and HARMONi-7 overseas enrollment [3] - For AK104, data readout for post-operative adjuvant therapy in liver cancer is anticipated, along with potential global development plans [3][4] - Other significant data readouts include the final data for the combination of Paimu Li and Anru Te Ni in advanced liver cancer and the monoclonal antibody for moderate to severe atopic dermatitis [4] Financial Projections - The company is projected to achieve revenues of 3.732 billion yuan, 5.149 billion yuan, and 7.628 billion yuan in 2025, 2026, and 2027, respectively, with growth rates of 75.70%, 37.98%, and 48.14% [4] - Expected net profits for the same years are -75 million yuan, 335 million yuan, and 1.401 billion yuan [4] - The ongoing expansion of the R&D pipeline and the successful launch of innovative products are expected to contribute positively to the company's long-term sustainable growth [4]

Core Viewpoint - The innovative drug sector in China is experiencing a significant resurgence, driven by policy relaxation, industry enthusiasm, and soaring stock prices, with the Hang Seng Innovative Drug Index showing a remarkable increase of 93.46% year-to-date [2] Policy Changes - The National Healthcare Security Administration announced the initiation of the 11th batch of drug procurement, establishing the principle that "procurement does not apply to new drugs," which protects the core profit expectations of innovative drug companies [4] - Recent regulatory changes by the China Securities Regulatory Commission and the Shanghai Stock Exchange aim to enhance the inclusivity of the Sci-Tech Innovation Board, addressing financing challenges for unprofitable biotech firms [4][5] - A multi-tiered medical insurance system is being developed to support the high-priced innovative drugs, providing a pathway for their market entry [5] Industry Dynamics - The innovative drug sector is transitioning from merely selling drugs to monetizing intellectual property, with a notable increase in overseas licensing deals [6][7] - In the first half of 2025, companies in the BioBAY park completed nearly $12 billion in overseas transactions, indicating a strong market for licensing agreements [7] - Major licensing deals, such as the $6.05 billion agreement between 3SBio and Pfizer, highlight the growing recognition of Chinese R&D quality [7] Investment Trends - The investment logic is shifting from speculative bets on scientific breakthroughs to value-based assessments as revenue streams become more predictable [7][10] - The enthusiasm in the secondary market is positively influencing the entire industry chain, with improved confidence being transmitted from the secondary to the primary market [7] R&D Investment - According to KPMG's report, the proportion of R&D investment among A-share health technology companies has been steadily increasing, yet remains low at around 5.1% in 2023 [8]

Core Viewpoint - The article highlights a silent revolution in the biotechnology sector in China, where domestic pharmaceutical companies are emerging as global leaders in drug discovery, particularly in the innovative drug segment, contrasting with the rapid advancements in AI technology [1]. Group 1: Market Performance and Trends - The Hong Kong innovative drug sector has seen significant growth, with ETFs like Huatai-PB and others rising by approximately 42% year-to-date as of May 30 [1]. - Chinese innovative drug companies have made notable strides in international markets, exemplified by the $60 billion exclusive development agreement between 3SBio and Pfizer, setting a record for domestic drug licensing [1]. - The total transaction amount for potential business collaborations by companies like CSPC Pharmaceutical is nearing $50 billion, indicating a robust trend in high-value overseas licensing deals [1]. Group 2: Growth Metrics - The number of innovative drugs approved in China has surged from 3 in 2015 to 39 in 2024, marking a 12-fold increase and elevating China from third to second place globally [6]. - The number of innovative drugs undergoing clinical trials in China has increased from 124 in 2015 to 704 in 2024, a 4.7-fold rise, positioning China as the leader in this category [6]. - The procurement amount for innovative drugs in hospitals with over 100 beds has grown from 137.2 billion yuan in 2015 to 257.6 billion yuan in 2024, an 88% increase, with its share of total procurement rising from 20.9% to 29.2% [7]. Group 3: Factors Driving Growth - The return of overseas-educated talent has significantly contributed to the innovation landscape in China's biotechnology sector, as many skilled researchers transitioned from corporate labs to entrepreneurial ventures [11]. - The establishment of a robust diagnostic and reagent business in China during the early 2000s laid the groundwork for advancements in biotechnology [13]. - The increasing domestic market demand, driven by a large and aging population, has created substantial opportunities for innovative drug development, particularly for treatments related to chronic diseases and cancer [12]. Group 4: Global Opportunities and Challenges - The global pharmaceutical market is facing a wave of patent expirations, prompting companies to seek external collaborations, where China's strong R&D capabilities can meet international demands [14]. - The licensing model is seen as a necessary step for Chinese biotech firms to gain experience and eventually achieve global distribution and trial capabilities [10]. - Despite the current reliance on licensing, there is potential for Chinese companies to evolve into global leaders in biotechnology as their ecosystems mature [18]. Group 5: Innovation and Competitive Landscape - China's biotechnology sector is recognized for its rapid iteration and improvement of existing drugs, which is a form of innovation that benefits society significantly [18]. - The development of the bispecific antibody Ivosidenib, which reportedly outperforms Keytruda, exemplifies China's growing technical prowess in biotechnology [18]. - The perception of innovation in China is shifting, as the ability to produce better and safer versions of existing drugs is increasingly valued [33].

Market Performance Overview - Hong Kong stocks showed varied performance from May 1 to present, with notable gainers including Xinda Biopharmaceutical (15.53%) and XPeng Motors (10.36%), while Weilan Delicious saw a decline of 15.42% [1] - A-share market also had mixed results, with Bai Run Co. increasing by 9.27% and Yanqing Beer by 8.70%, while Yanjin Beer fell by 2.78% [1] - In the US market, Vistra led with a 23.22% increase, while UnitedHealth Group experienced a significant drop of 27.53% [1] Macroeconomic Context - The 20-year US Treasury auction results were weaker than expected, indicating soft demand for government debt, which led to declines across US stocks, bonds, and currencies [2] Trade Relations and Tariffs - US-China trade talks on May 12 resulted in a temporary suspension of some tariffs, alleviating market concerns and boosting investor confidence [3] - Japan is pursuing a $44 billion LNG project and technology sharing to reach a tariff agreement with the US, while ongoing negotiations with the EU remain unresolved, posing potential risks for US stocks, particularly in tech and industrial sectors [3] Export Trends - China's exports to the US fell by 21% in April, but a recovery in demand is anticipated as US retailers increase orders ahead of major holidays [4] - Shanghai port saw a 49.4% week-on-week increase in export container volume, indicating strong demand and a backlog of orders extending into June [7] Tourism Sector Insights - The upcoming travel season is expected to see a surge in bookings, with a 63% year-on-year increase in orders for the Dragon Boat Festival holiday [9] - Ctrip and Tongcheng Travel are highlighted as key players, with Ctrip focusing on high-end markets and Tongcheng targeting lower-tier consumers [9][10] Consumer Trends - The Z generation's consumption potential is rising, with a focus on value-for-money and personalized products [10] - Companies like Wancheng Group are recommended for investment due to their strong market position and growth potential in the snack industry [10] AI and Technology Sector - The demand for AI infrastructure remains robust, with companies like NVIDIA and AMD positioned as key players in the market [15][16] - Upcoming tech events in June are expected to drive further interest and investment in the sector [17] Stock Adjustments and Earnings - The Hang Seng Index is set for adjustments in June, with potential new additions to the Hong Kong Stock Connect [20] - Companies like NIO and various US firms are expected to report earnings in June, which could influence market sentiment [21][22] Defensive Investment Strategies - Given the current macroeconomic uncertainties, investments in gold, banks, and utility sectors are recommended as defensive strategies [25]

Market Overview - Global markets showed mixed performance with the Hang Seng Index closing at 21,972, down 0.04% for the day but up 28.89% year-to-date [1] - The A-share market experienced a slight decline, with the Shanghai Composite Index down 0.20% and the Shenzhen Composite Index down 0.93% [3] - Southbound capital recorded a net inflow of HKD 2.03 billion [3] Company Analysis BYD Electronics (285 HK) - The company reported flat earnings for Q1 2025, primarily due to weak demand for high-end smartphones and potential tariff impacts on Apple’s assembly business [4] - The gross profit margin improved by 0.4 percentage points to 6.3% quarter-on-quarter, but decreased by 0.6 percentage points year-on-year [4] - Management maintains a positive outlook for 2025, citing growth in Apple assembly, stable Android business, strong automotive demand, and growth in servers/robots [4] Wentech Technology (600745 CH) - The company’s revenue decreased by 19.4% year-on-year to RMB 13.1 billion, but net profit surged by 82.3% to RMB 261 million [5] - The gross margin recovered to 14.0%, indicating resilience in the semiconductor business [5] - The company is transitioning to focus on semiconductor business after divesting its ODM operations, which is expected to drive future growth [5] Li Ning (2331 HK) - Retail sales growth deteriorated in April 2025, with management noting a decline in offline channels due to adverse weather and a challenging macro environment [6][7] - Despite the challenges, the company maintains its full-year guidance, expecting stable sales growth and high single-digit net profit margins [6] - The company’s Q1 retail sales growth was in line with expectations, with online channels performing strongly [7] China Pacific Insurance (2601 HK) - The company reported a 39% year-on-year increase in new business value for Q1 2025, exceeding expectations [11][12] - However, the group’s net profit fell by 18.1% to RMB 9.63 billion, primarily due to declines in bond fair value and mismatches in yield curves [11] - The management expects operational profit to maintain low single-digit growth for the year, supported by business transformation [13] Zhejiang Dingli (603338 CH) - The company’s EBIT grew by only 2% year-on-year to RMB 440 million, with net profit increasing by 42% due to non-operating income [10] - The company faces challenges from unpredictable U.S. tariff policies, which may impact demand for its products in the U.S. market [10] - The target price remains at RMB 44, reflecting a cautious outlook on profitability [10] 康方生物 (9926 HK) - The company continues to show promise with its drug AK112, which has demonstrated efficacy in clinical trials against competitors [9][10] - The ongoing trials in overseas markets are expected to yield significant data, enhancing the drug's potential for approval and market entry [9][10] - The target price for 康方生物 is set at HKD 108.03, maintaining a buy rating based on the drug's promising results [10]