Core Insights - Merck's PD-1 monoclonal antibody, Keytruda, has achieved global sales exceeding $20 billion in both 2023 and 2024, solidifying its position as the leading drug in the lung cancer market [1] Industry Overview - Lung cancer remains the leading cause of cancer globally, with 2.4 million new cases each year, and China reporting significantly higher new cases than other countries [3] - The rise of targeted and immunotherapy treatments has transformed the treatment landscape for lung cancer, with new therapies such as ADCs, bispecific antibodies, and tumor vaccines expanding treatment options [3] Competitive Landscape - A race is underway among pharmaceutical companies to establish the next generation of immunotherapy leaders in lung cancer, with companies like Junshi Biosciences, Kintor Pharmaceutical, and Innovent Biologics actively competing [2][3] - Junshi Biosciences has reported promising results for its PD-L1 ADC, HLX43, showing an objective response rate (ORR) of 33.3% in squamous non-small cell lung cancer (NSCLC) patients and 48.6% in non-squamous patients [2] - Kintor Pharmaceutical's PD-1/VEGF bispecific antibody, Ivoris, is currently undergoing eight pivotal phase III clinical trials [5] - Innovent Biologics has announced a collaboration with Takeda Pharmaceutical to co-develop a new generation of immunotherapy, IBI363, which targets PD-1 and IL-2α [6] Clinical Development - Junshi Biosciences plans to initiate at least eight phase III clinical trials for HLX43 in the lung cancer space, with additional studies planned for cervical cancer, esophageal squamous cancer, and colorectal cancer [2][7] - The cost of each global phase III clinical trial is estimated to be around $200 million, presenting a significant financial challenge for companies [7] Financial Performance - Junshi Biosciences reported revenue of 2.82 billion yuan in the first half of the year, a year-on-year increase of 2.7%, with net profit remaining stable at 390 million yuan [7]

Core Viewpoint - 康方生物 (09926.HK) experienced a nearly 5% increase in stock price, reaching 119.9 HKD with a trading volume of 310 million HKD [1] Group 1 - The stock price of 康方生物 rose by 4.72% [1] - The current trading price is 119.9 HKD [1] - The total trading volume amounted to 3.1 billion HKD [1]

Core Viewpoint - 康方生物's stock rose nearly 5%, reaching 119.9 HKD with a trading volume of 310 million HKD, following the announcement of the completion of the first patient dosing in a Phase I clinical trial for its personalized mRNA vaccine AK154 for postoperative adjuvant treatment of pancreatic cancer [1] Group 1: Company Developments - 康方生物 announced that its first self-developed personalized mRNA vaccine, AK154, has completed the first patient dosing in a Phase I clinical trial [1] - AK154 is the company's first mRNA drug to enter clinical stages, marking a significant breakthrough in the mRNA technology field after establishing advantages in multi-specific antibodies and antibody-drug conjugates [1] - The vaccine is developed based on an mRNA technology platform, utilizing tumor tissue sequencing and algorithms to select high-affinity immunogenic gene mutations for the preparation of specific mRNA vaccine sequences [1] Group 2: Clinical Trial Insights - AK154 aims to reverse the "cold tumor" characteristics of pancreatic cancer and is expected to enhance anti-tumor immunity when used in combination with immune dual antibodies [1] - The combination of AK154 with either the PD-1/CTLA-4 dual antibody or the PD-1/VEGF dual antibody is anticipated to produce a synergistic effect, further boosting the immune response against tumors [1]

Core Viewpoint - 康方生物's stock rose nearly 5%, reaching 119.9 HKD with a trading volume of 310 million HKD following the announcement of the completion of the first patient dosing in a Phase I clinical trial for its personalized mRNA vaccine AK154 for postoperative adjuvant treatment of pancreatic cancer [1] Group 1: Company Developments - 康方生物 announced the completion of the first patient dosing in a Phase I clinical trial for its self-developed personalized mRNA vaccine AK154, in combination with either the PD-1/CTLA-4 dual antibody or the PD-1/VEGF dual antibody for pancreatic cancer treatment [1] - AK154 is 康方生物's first mRNA drug to enter clinical stages, marking a significant breakthrough in the mRNA technology field after establishing a leading position in multi-specific antibodies and antibody-drug conjugates [1] - The AK154 vaccine is developed based on an mRNA technology platform, utilizing tumor tissue sequencing and algorithms to select high-affinity immunogenic gene mutations, aiming to reverse the "cold tumor" characteristics of pancreatic cancer [1] Group 2: Clinical Research Insights - The combination of AK154 with immune dual antibodies is expected to produce a synergistic effect, further enhancing anti-tumor immunity [1]

Core Insights - The Hong Kong Innovative Drug ETF (159567) closed down 0.48% on November 11, with a trading volume of 854 million yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of November 10, 2024, the fund's latest share count was 9.675 billion, with a total size of 8.015 billion yuan, reflecting a significant increase in both share count and size compared to the previous year [1] Fund Performance - The fund's share count increased by 2347.04% and its size increased by 2021.31% from 3.95 million shares and 378 million yuan on December 31, 2024 [1] - Over the past 20 trading days, the cumulative trading amount reached 24.964 billion yuan, with an average daily trading amount of 1.248 billion yuan [1] - Year-to-date, the cumulative trading amount for 207 trading days was 244.556 billion yuan, with an average daily trading amount of 1.181 billion yuan [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 65.68% during the management period [2] - The fund's top holdings include companies such as BeiGene, CanSino Biologics, Innovent Biologics, and others, with significant percentages of the portfolio allocated to these stocks [2] - The largest holdings by percentage include BeiGene at 10.62%, CanSino Biologics at 10.55%, and Innovent Biologics at 10.21% [2]

Investment Rating - The report does not explicitly state an investment rating for the industry [1] Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 2.4% from November 3 to November 7, 2025, underperforming compared to the Wind All A index (0.63%) and the CSI 300 index (0.82%) [2][7] - The rise in flu activity was noted, with the percentage of flu-like illness (ILI) cases reported at 4.7% in the week of October 27 to November 2, 2025, indicating an increase compared to previous weeks and years [2][10] - The final overall survival (OS) results from the HARMONi-A study of Ivosidenib combined with chemotherapy for EGFR-mutant non-small cell lung cancer showed a significant improvement in OS, with a median OS of 16.8 months versus 14.1 months for the control group [2][10] Weekly Market Review - The pharmaceutical and biotechnology sector's performance was down 2.4%, with notable declines in medical research outsourcing (-4.93%), chemical preparations (-4.42%), and other biological products (-4.33%) [7][8] - The leading gainers included Hezhi China (61.1%), Wanze Shares (30.3%), and Fuxiang Pharmaceutical (23.3%), while Changshan Pharmaceutical (-20%), Yifang Bio-U (-17.8%), and Guangshengtang (-15.3%) were the biggest losers [10] Industry News and Key Company Announcements - On November 7, 2025, the final OS analysis of the HARMONi-A study was presented, showing significant results for Ivosidenib in combination with chemotherapy [10][12] - According to data from the Chinese Center for Disease Control, flu-like illness percentages in southern provinces increased to 4.6%, while northern provinces reported 5.1%, both higher than the previous week [10][12] - BeiGene reported a total revenue of $1.412 billion for Q3 2025, a 41% year-on-year increase, driven by a 51% growth in global sales of its product [12][14] - Metsera announced a merger agreement with Pfizer, with an estimated total transaction value of approximately $9 billion [12][14]

Group 1 - The core viewpoint of the news highlights the strong performance of the Hong Kong Stock Connect Innovative Drug ETF, which has gained 1.2% with a trading volume of 351 million yuan and a total fund size of 2.079 billion yuan as of November 10 [1] - Key performing stocks within the ETF include InnoCare Pharma-B, Bionet, and Ascletis Pharma, with respective gains of 5.4%, 4.43%, and 4.37% [1] - Conversely, stocks such as Kangzhe Pharmaceutical, MIRXES-B, and Innovent Biologics showed weaker performance, with declines of 1.28%, 0.94%, and 0.65% respectively [1] Group 2 - The innovative drug sector is identified as the largest investment opportunity in the pharmaceutical sector for 2025, with a focus on dual/multi-target drugs, chronic disease medications addressing unmet clinical needs, and ADCs [2] - There is a noted improvement in domestic and international innovative drug financing data, with an upward trend in CXO industry orders, indicating a potential recovery in valuations and performance [2] - The medical device sector is experiencing accelerated approvals for innovative products, such as the approval of the chest and abdominal aortic stent system by Xianjian Technology, which is expected to enhance long-term profit margins [2] Group 3 - The Hong Kong Stock Connect Innovative Drug ETF and its linked funds passively track the Hang Seng Hong Kong Stock Connect Innovative Drug Select Index, with the top ten weighted stocks including BeiGene, China Biologic Products, and Innovent Biologics [3]

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology industry [1]. Core Views - The report highlights a positive change in the specialty raw materials sector, recommending companies such as Aorite and Prolo Pharmaceuticals [1]. - The report suggests that the Q3 performance of raw material pharmaceutical companies has reached a bottom, indicating potential recovery in profitability as high-cost inventory is consumed [19][20]. Summary by Sections Investment Highlights - The recommended sub-industry rankings are: Innovative Drugs > Research Services > CXO > Traditional Chinese Medicine > Medical Devices > Pharmacies [3][12]. - Specific stock recommendations include: - From raw materials: Aorite, Qianhong Pharmaceutical - From Traditional Chinese Medicine: Zorui Pharmaceutical, Fangsheng Pharmaceutical, Dong'e Ejiao - From medical devices: United Imaging Healthcare, Yuyue Medical - From AI pharmaceuticals: Jingtai Holdings - From GLP-1 sector: Lianbang Pharmaceutical, Borui Pharmaceutical, Zhongsheng Pharmaceutical, and Innovent Biologics - From PD-1/VEGF dual antibodies: Sanofi Biopharmaceuticals, Kangfang Biologics, and Rongchang Biopharmaceuticals - From innovative drugs: Innovent Biologics, BeiGene, HengRui Medicine, Zai Lab, Baillie Tianheng, Kelun Pharmaceutical, Dize Pharmaceutical, and Haizheng Pharmaceutical [3][15]. Industry Trends - The A-share pharmaceutical index has seen a year-to-date increase of 18.2%, while the Hang Seng Biotechnology Index has increased by 76.6% [6][11]. - The report notes that the raw material pharmaceutical sector is under pressure due to high base effects and declining prices, with significant revenue impacts [19][20]. R&D Progress and Company Dynamics - Recent approvals include Novartis' radioligand therapy drug, which received dual indications for prostate cancer treatment [2]. - The report provides an overview of ongoing clinical trials and drug approvals, emphasizing the importance of innovation in the pharmaceutical sector [30]. Market Performance - The report indicates that the pharmaceutical sector has experienced adjustments, with notable stock performances including significant gains for companies like Hezhong China (+61%) and Wanze Shares (+30%) [11]. - The report also highlights the performance of various pharmaceutical stocks, noting both gains and losses in the market [16][17]. Raw Material Pricing Trends - The price of 6-APA has dropped significantly, from 370 RMB/kg in 2022 to 180 RMB/kg in October 2025, a decrease of 51% [23]. - The price of Amoxicillin has also decreased from 320 RMB/kg in January 2023 to 190 RMB/kg in October 2025, a decline of 41% [23]. Conclusion - The report suggests that as high-cost inventory is depleted, the gross margins for raw material producers are expected to improve, indicating a potential recovery in profitability for companies like Fuxiang Pharmaceutical and Lukang Pharmaceutical [19][23].

Core Insights - The article presents a ranking of 78 unprofitable biotechnology companies listed in Hong Kong, highlighting their market capitalizations and stock prices as of October 31, 2025 [1][2][3]. Market Capitalization Summary - The top three companies by market capitalization are: 1. 名要放田 (Ming Yao Fang Tian) with a market cap of HKD 286.26 billion 2. 信达生物 (Innovent Biologics) with a market cap of HKD 149.08 billion 3. 科伦博泰生物-B (Kintor Pharmaceutical) with a market cap of HKD 104.47 billion [1][2]. Price Performance Summary - The highest price increase for the year is observed in: 1. 北海康成-B (Beihai Kangcheng) with a price increase of 1381.20% 2. 药康安康 - B (Yao Kang An Kang) with a price increase of 1297.72% 3. 三叶草生物-B (San Ye Cao) with a price increase of 812.86% [3][4]. Additional Performance Insights - Other notable performers include: - 德棋医药-B (Deqi Pharmaceutical) with a 696.92% increase - 和铂失药-B (He Bo Shi Yao) with a 624.19% increase - 荣昌生物 (Rongchang Biologics) with a 525.00% increase [3][4]. Overall Trends - The article indicates a significant volatility in the biotechnology sector, with many companies experiencing substantial price fluctuations, reflecting investor sentiment and market dynamics [3][4].

Core Viewpoint - The article discusses the contrasting experiences of Chinese and foreign pharmaceutical companies in the innovative drug market, particularly focusing on the emergence of dual-target weight loss drugs and the financial implications of drug licensing agreements [4][8]. Group 1: Market Dynamics - The dual-target weight loss drug "Tirzepatide," developed by Eli Lilly, generated sales of $16.4 billion last year due to its ability to mimic two natural hormones, GLP-1 and GIP, effectively suppressing appetite and controlling blood sugar [4][6]. - In contrast, Chinese company Hansoh Pharmaceutical's HS-20094, also a dual-target drug, was licensed to Regeneron for an upfront payment of only $80 million, highlighting the disparity in financial returns between Chinese and foreign firms [6][11]. Group 2: Drug Development Challenges - The pharmaceutical industry operates under a "three tens" rule: 10 years of development, $1 billion investment, and a 10% success rate, indicating the high risks associated with innovative drug development [12][13]. - Innovative drugs are categorized into two types: First-in-class, which are groundbreaking treatments, and Fast Follow, which modify existing drug structures without infringing on patents [14][17]. Group 3: Competitive Landscape - Chinese pharmaceutical companies have made significant strides, with their first-in-class drugs accounting for 24% of the global pipeline, second only to the United States [19]. - The article notes that multinational corporations are increasingly seeking to acquire Chinese innovative drugs due to the expiration of their own patents and the high costs of internal R&D [21]. Group 4: R&D Efficiency - Chinese companies excel in the speed of drug development, particularly in patient recruitment for clinical trials, which can take significantly less time compared to the U.S. [22]. - The rise of the CRO (Contract Research Organization) industry in China has created a large pool of skilled researchers familiar with international standards, enhancing the country's R&D capabilities [25][27]. Group 5: Globalization of Chinese Pharma - The article emphasizes that the ultimate goal for Chinese innovative drug companies is to enter global markets, as the potential market of 7 billion people far exceeds that of 1.4 billion in China [38]. - The licensing-out model allows Chinese companies to secure upfront payments to fund further R&D while granting multinational firms rights to sell their drugs in other markets [39]. Group 6: Social Responsibility and Challenges - The article highlights the social responsibility of pharmaceutical companies, citing the case of Betta Pharmaceuticals, which provided free life-saving drugs worth nearly $13 billion to patients [40]. - However, it also points out the challenges faced by companies like Betta, which have encountered product shortages and financial difficulties, raising questions about the sustainability of their charitable initiatives [42].