Core Viewpoint - 康方生物-B (09926) has made significant progress in its core product pipeline, with multiple products receiving approvals and entering advanced clinical stages, indicating strong growth potential and investment opportunities [1] Financial Performance - In the first half of 2025, 康方生物 reported a 49.2% year-on-year increase in product revenue to 1.4 billion yuan, with total revenue reaching 1.41 billion yuan, and a gross margin of 79.4%. R&D expenses grew by 23.0% to 730 million yuan. The company raised net proceeds of 3.493 billion HKD from a share placement, resulting in a projected cash balance of 5.8 billion HKD post-placement [2] Product Pipeline Progress - **卡度尼利 (AK104)**: Approved for use in 1st to 3rd line cervical cancer and 1st line gastric cancer, included in medical insurance. Multiple new indications are in Phase III clinical trials, including treatments for gastric cancer and liver cancer [3] - **依沃西 (AK112)**: Approved for non-small cell lung cancer (NSCLC) after EGFR treatment, with positive survival data. A submission for FDA approval is expected in Q4 2025. Several other indications are in Phase III clinical trials [4] - **派安普利单抗 (AK105)**: Received FDA approval for first and second line nasopharyngeal carcinoma treatment, marking a significant achievement for the company [5] - **伊努西单抗 (AK102)** and **依若奇单抗 (AK101)**: Both are included in the 2026 medical insurance [6] - **古莫奇单抗 (AK111)**: Application for moderate to severe psoriasis has been accepted as of January 2025. Other products are in various stages of clinical trials [7]

Investment Rating - The report assigns a "Buy" rating with a target price of HKD 144.9, indicating a potential upside of 23.4% from the current price of HKD 117.4 [3][5]. Core Insights - The company reported a significant increase in product revenue by 49.2% year-on-year to RMB 1.4 billion in the first half of 2025, despite a net loss of RMB 570 million, which is an increase of 139% in losses compared to the previous year [1]. - The company has made substantial progress in its product pipeline, with multiple drugs in various stages of clinical trials and approvals, including AK104 and AK112, which have shown promising results in treating various cancers [2]. - The financial outlook shows a projected revenue increase from RMB 2.1 billion in 2024 to RMB 5.6 billion by 2027, with a recovery in net profit expected by 2027 [4][7]. Financial Summary - For the fiscal year ending December 31, 2023, the company is expected to generate revenue of RMB 4.53 billion, with a gross margin of 97.1% [4][7]. - The net profit is projected to turn positive by 2027, with an estimated net profit of RMB 260 million [4][7]. - The company has a strong cash position, with net cash expected to be RMB 5.8 billion post-financing activities [1].

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" (maintained) [1] Core Insights - The 2025 National Medical Insurance Negotiation results were announced, with 114 new drugs added to the medical insurance directory, achieving an overall success rate of 88%, the highest in nearly seven years, with a maximum price reduction of 94 [4][19] - The newly added drugs include monoclonal antibodies, bispecific antibodies, ADCs, siRNA, and small molecules, indicating a strong focus on innovative therapies [19][32] - The commercial insurance directory has added 19 innovative drugs, which, while not reimbursed by medical insurance, receive support for innovative drug applications, enhancing patient access and benefiting the innovative drug industry [5][24] Summary by Sections 1. National Medical Insurance Negotiation Results - The 2025 medical insurance directory added 114 new drugs, with a success rate of 88% and a maximum price reduction of 94% [4][13] - The total number of drugs in the national medical insurance directory reached 3,253, including 1,857 Western medicines and 1,396 traditional Chinese medicines [16][17] - The directory reflects a significant increase in the inclusion of innovative drugs, with 50 of the new additions classified as category 1 innovative drugs [19][21] 2. Commercial Insurance Directory - The commercial insurance directory added 19 innovative drugs, highlighting their clinical value and innovation [24][28] - The directory includes treatments for diseases such as Alzheimer's, rare diseases in children, and other critical conditions, showcasing a focus on addressing unmet medical needs [24][28] - The support for innovative drugs in the commercial insurance directory aims to fill gaps in patient coverage and enhance the overall healthcare system [25][28] 3. Market Performance - In the second week of December, the pharmaceutical and biotechnology sector declined by 1.04%, underperforming the CSI 300 index by 0.96 percentage points [6][34] - The medical research outsourcing sector showed the highest increase, up by 3.69%, while offline pharmacy and medical circulation sectors experienced the largest declines [6][36] 4. Recommended Companies - The report continues to favor innovative drugs and their supply chain, recommending companies such as Sanofi, Innovent Biologics, and others for investment [7][32]

Core Insights - The pharmaceutical industry is experiencing a surge in innovative products, with clear domestic demand and significant potential for international expansion [4][14][25] - Investment opportunities are concentrated in innovative drugs and their supply chains, with a notable performance from CRO/CMO and chemical pharmaceuticals [9][15][17] - The report emphasizes the importance of innovation as the primary solution to industry challenges, driven by stable demand and supportive policies [26][32][41] Industry Overview - The pharmaceutical sector has faced revenue declines, with a 0.9% year-on-year decrease in revenue for the first three quarters of 2025, and net profit down by 2.2% [15][16] - The innovative drug sector has outperformed, with CRO/CMO and chemical pharmaceuticals showing net profit growth of 31.0% and 16.6% respectively [17][18] - The overall market is characterized by low fund holdings and historical valuation bottoms, indicating high investment value [20][25] Demand and Payment Dynamics - The demand for healthcare services is steadily increasing, with a projected 5% growth in total medical visits and hospital admissions in 2024 [26][28] - The aging population is expected to drive long-term demand, with 220 million people aged 65 and above by 2050 [28][30] - The medical insurance fund's income growth has outpaced expenditure growth, leading to a significant increase in fund reserves [32][36] Financing and Market Trends - The IPO market for healthcare has rebounded, with 28 IPOs in the first three quarters of 2025, a 100% increase from the previous year [42][43] - License-out transactions have surged, with transaction numbers increasing by 41% and total amounts reaching $92 billion, indicating a robust market for innovative drug licensing [48][50] - The number of IND applications and new clinical trials for innovative drugs has been steadily increasing, with a notable rise in NDA approvals [53][57] Technological Advancements - The report highlights the emergence of new technologies such as ADC and small nucleic acids, with domestic companies leading in these areas [60] - The focus on dual antibodies and GLP-1 drugs is expected to drive significant growth, with multiple development directions emerging [9][60] - The report notes that domestic companies are increasingly recognized for their innovative capabilities, particularly in the ADC space [60]

Core Viewpoint - The stock price of Kangfang Biotech (09926) is currently at 121 HKD, reflecting a 3.6% increase, with significant market activity and divergent views among investors [1][5]. Market Performance - Over the past five days, the stock has shown a volatility of 11.9%, with a trading volume of 236 million HKD, indicating active trading [1]. - Other stocks in the same sector have varied performances, with BeiGene (06160.HK) up 0.95% at 191.5 HKD, Innovent Biologics (01801.HK) up 0.24% at 83.75 HKD, and others showing declines [1]. Technical Analysis - The current stock price is slightly below the 10-day moving average (121.5 HKD) but above the 30-day moving average (116.85 HKD), indicating short-term pressure while the mid-term structure remains intact [2]. - Key support levels are identified at 111.7 HKD (Support 1) and 103.3 HKD (Support 2), with resistance levels at 123 HKD (Resistance 1) and 130.3 HKD (Resistance 2) [2]. - The overall probability of an upward movement is estimated at 56%, suggesting a slightly positive outlook [2]. Fundamental Catalysts - A significant recent development is the inclusion of all five self-developed drugs by Kangfang Biotech in the latest National Medical Insurance catalog, effective January 1, 2026 [5]. - This inclusion is viewed as a critical step towards accelerating the commercialization of innovative drugs, with expectations of rapid sales growth following the listing [5]. Investor Sentiment - Investor opinions are divided into three main perspectives: 1. Optimistic view anticipating significant stock price increases due to potential market expansion from medical insurance [5]. 2. Cautious view considering previous price volatility, leading some investors to take profits at current levels [5]. 3. Pessimistic view predicting a potential price correction to around 110 HKD for consolidation [5]. Derivative Products - In a volatile market, the leverage characteristics of derivative products are highlighted, with examples showing significant price movements in response to stock fluctuations [6][7]. - For bullish investors, options such as Huatai call warrants (22043) with a strike price of 138 HKD and a leverage of 2.7 times are recommended [9]. - For bearish investors, Huatai put warrants (29749) with a strike price of 95 HKD and a leverage of 1.2 times are suggested for hedging against potential declines [16].

12月12日午后，港股通创新药板块回暖，高弹性港股通创新药ETF（520880）翻红后持续拉升，现涨超 1%，今日有望终结日线4连阴形态。值得关注的是，本周520880迎来"抄底"资金增仓，累计净申购额超 1.3亿元。 成份股方面，权重龙头股康方生物领涨逾6.8%，信达生物涨超2%，百济神州涨逾1%。云顶新耀、同源 康医药-B、映恩生物-B等涨幅居前。 据康方生物官微消息，其全球首创的PD-1/CTLA-4双特异性抗体卡度尼利单抗联合化疗，对比化疗联 合或不联合纳武利尤单抗，用于HER2阴性、未经治疗的不可切除或转移性胃或胃食管结合部腺癌一线 治疗的国际多中心Ⅲ期临床研究(COMPASSION-37/AK104-311)，已获得美国食品药品监督管理局 (FDA)批准开展。 平安证券研报提示，从BD、商业化、政策三个角度看，创新药崛起具备持续性，建议关注：1）管线布 局丰富的创新药公司；2）创新药单品潜力大，价格有望重估的企业；3）看好前沿技术平台布局领先的 企业。 1、纯粹，全面。不含CXO，纯正创新药！全面覆盖创新药研发类公司。 2、龙头占比大。前十大创新药龙头权重超72%，表征创新药硬核力量。 3、风险更 ...

12月12日午后，港股通创新药板块回暖，高弹性港股通创新药ETF（520880）翻红后持续拉升，现涨超 1%，今日有望终结日线4连阴形态。值得关注的是，本周520880迎来"抄底"资金增仓，累计净申购额超 1.3亿元。 | 分时 多日 1分 5分 * | | | | F9 盘前盘后 图加 九50 图线 工具 @ (2 > | | | | | 港股通创新药ETF ① | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 0.54 | | | 520880[種設通创新的ETF] 14:29 价 0.544 滚球 0.006(1.12%) | | | | 0.544 +0.006 +1.12% | | | 520880 | | 0.543 | | | | | DATES | | SSE CNY 14:29:30 交易中 查看L2全国 | | | 40 8 7 8 | | | | | | | | 净值击势 | 华宜恒生港胶通创新的用 | | 69.80 | | | 0.54 | | | | | 0.45 | 1248 | - ...

智通财经获悉，康方生物(09926)再涨超3%，截至发稿，涨3.83%，报121.9港元，成交额2.71亿港元。 消息面上，据康方生物官微消息，近日，公司宣布，全球首创的PD-1/CTLA-4双特异性抗体卡度尼利单 抗联合化疗，对比化疗联合或不联合纳武利尤单抗，用于HER2阴性、未经治疗的不可切除或转移性胃 或胃食管结合部腺癌一线治疗的国际多中心Ⅲ期临床研究(COMPASSION-37/AK104-311)，已获得美国 食品药品监督管理局(FDA)批准开展。 据悉，COMPASSION-37研究是卡度尼利第二个国际多中心注册性临床研究。此前，卡度尼利方案治疗 免疫耐药肝细胞癌的国际注册性临床研究已经在美国开展。COMPASSION-37研究的开展是卡度尼利的 全球化开发向前再迈出的关键性一步，也是康方生物全球化战略的重要举措，将有力巩固公司在肿瘤免 疫2.0 领域的国际领先地位。 本文源自：智通财经网 ...

Group 1 - The core viewpoint of the article highlights the positive impact of the Federal Reserve's interest rate cut on the Hong Kong stock market, particularly in the biotechnology sector, which is expected to see valuation recovery due to improved liquidity conditions [1][2] - The article discusses the ongoing optimization of the policy environment in the pharmaceutical industry, emphasizing the shift from price competition to value competition, supported by innovative payment models and regulatory measures [1][2] - The introduction of the Hang Seng Biotechnology Index futures is seen as a significant step in enhancing the investment ecosystem for the biotechnology sector, attracting long-term capital and stabilizing market expectations [3] Group 2 - The biotechnology sector is positioned for structural allocation opportunities due to its current low valuation levels and favorable policy support, with significant inflows from southbound capital [4] - The article notes that small nucleic acid drugs are emerging as a core area for innovation, with recent breakthroughs in delivery technology expanding their therapeutic applications [2] - The performance of leading biopharmaceutical companies and the increase in overseas collaborations indicate a strengthening of the industry's fundamentals and confidence [1][2]

每经AI快讯，康方生物(09926.HK)涨超3%，截至发稿，涨3.83%，报121.9港元，成交额2.71亿港元。 （文章来源：每日经济新闻） ...