Core Insights - The pharmaceutical MNC supply chain has extremely high entry barriers, requiring years for supplier certification through cross-departmental audits in technology, quality, EHS, and compliance. Once included in the qualified supplier list, a strong lock-in effect is formed, making it difficult for new entrants to disrupt the existing supply structure even if they meet technical standards, thus demonstrating a strong first-mover advantage [4][7]. - MNCs demand far more than conventional quality compliance, emphasizing full-process controllability and risk management capabilities. Compliance with guidelines such as EU GMP and ICHQ is required, along with the establishment of traceability systems and safety stock. Any process changes or relocation of production sites must undergo strict and time-consuming certification [4][7]. - In procurement decisions, MNCs are relatively insensitive to price factors, prioritizing the integrity of the supply chain over cost. For MNCs, API costs represent only a small portion of their terminal formulation sales, leading them to pay a premium for stable, traceable, and zero major quality incident supply capabilities, viewing supply chain resilience as a core competitive advantage rather than a cost item. Thus, entering the MNC supply chain often means effectively avoiding "price internalization" [4][7]. - Investment recommendations include innovative drug and device companies such as Furuya Co., Aonlikang, Shutaishen, Weichuang Bio, and others. From the perspective of CXO and raw materials, companies like WuXi AppTec, Jiuzhou Pharmaceutical, Chengda Pharmaceutical, and others are suggested for attention [4][7]. Market Performance Overview - As of November 21, 2025, the TTM-PE of the pharmaceutical and biotechnology industry is 48.84 times, which is 100% higher than the historical lowest PE valuation of 24.38 times on January 3, 2019. The premium rate relative to the CSI 300 is 252%, exceeding the historical lowest valuation premium of 124% on February 6, 2018, by 128 percentage points, and is 11 percentage points higher than the average valuation premium rate of 241% over the past decade [8][12]. - From November 17 to November 21, 2025, the pharmaceutical and biotechnology sector experienced a decline of 6.88%, ranking 22nd among 27 sub-industries. The chemical raw materials sector saw the largest decline at -8.60% [12][15]. Industry Dynamics - Pfizer's Class 1 new drug, Matacizumab, was approved for marketing on November 21, 2025, for the routine prevention and treatment of bleeding in patients with severe hemophilia A or B [20]. - Boehringer Ingelheim's Class 1 new drug, BI764198, was proposed for inclusion as a breakthrough therapy on November 18, 2025, targeting primary focal segmental glomerulosclerosis [21]. - The PD-1 inhibitor H drug, Surulutumab, developed by Fuhong Hanlin, was officially included as a breakthrough therapy on November 20, 2025, for gastric cancer treatment [22]. - On November 17, 2025, FDA approved the biosimilar of Tysabri, developed by Sandoz, for multiple sclerosis and Crohn's disease [23].

Investment Rating - The report maintains an investment rating of "Outperform" with a rating of A [7] Core Insights - The report highlights significant advancements in small nucleic acid drugs for the treatment of hepatitis B, particularly the promising data from the drug AHB-137 presented at the AASLD 2025 conference, indicating its potential as the best small nucleic acid drug for hepatitis B [3][22] Summary by Sections Weekly New Drug Market Review - From November 17 to November 23, 2025, the top five gainers in the new drug sector were: - LaiKai Pharmaceutical (+13.34%) - Beihai Kangcheng (+2.67%) - Jiahe Biotech (+2.19%) - Yongtai Biotech (+1.94%) - Youzhi You (+1.14%) - The top five losers were: - WuXi AppTec (-15.75%) - Adi Pharma (-14.56%) - Mengke Pharma (-14.34%) - Yiming Oncology (-13.40%) - Kain Technology (-13.04%) [1][16] Weekly Focused Investment Targets - The report suggests focusing on several promising targets due to upcoming catalysts, including: 1. Products with high certainty for overseas expansion certified by MNCs: Sanofi, Federated Pharmaceuticals, and Kelun-Botai 2. Products with overseas data catalysts: Betta Pharmaceuticals, Hutchison China MediTech, and Yiming Biotech 3. Potential blockbuster products for overseas licensing by MNCs: Fuhong Hanlin, CSPC Pharmaceutical Group, and Yifang Biotech 4. New innovative drug technology breakthroughs: small nucleic acids, in vivo CAR-T, fat reduction and muscle gain, autoimmune CAR-T/bispecific antibodies, and gene therapy [2][20] Weekly New Drug Industry Analysis - The report emphasizes the breakthrough data for small nucleic acid drugs in treating hepatitis B, particularly the two-phase follow-up data for AHB-137, which shows a high potential for becoming the leading small nucleic acid drug in this field [3][22] Weekly New Drug Approval & Acceptance Status - No new drug or new indication approvals were reported this week, but six new drug or new indication applications were accepted [4][24] Weekly New Drug Clinical Application Approval & Acceptance Status - This week, 42 new drug clinical applications were approved, and 44 new drug clinical applications were accepted [5][26] Domestic Market Key Events TOP3 - Key events included: 1. Zean Biopharma's strategic collaboration with GSK to develop up to four "first-in-class" candidates in oncology [11] 2. Innovent Biologics announcing successful Phase III clinical study results for a drug in moderate to severe obesity [11] 3. Fuhong Hanlin's FDA approval for a biosimilar product [11] Overseas Market Key Events TOP3 - Key events included: 1. Merck's presentation of key Phase III trial results at the AHA Scientific Sessions [12] 2. Johnson & Johnson's acquisition of Halda Therapeutics for $3.05 billion [12] 3. The EMA's recommendation for the approval of a gene therapy product [12]

Macro and Strategy Research - The scale of off-balance sheet financing and direct financing has increased, with a notable rise in entrusted loans and corporate bond financing, while overall social financing showed a year-on-year decrease of nearly 600 billion yuan in October [2][3] - The loan data indicates a weak demand, with a year-on-year decrease of 280 billion yuan in RMB loans, and a significant increase in corporate bill financing, reflecting a trend of companies being cautious about expanding capacity [2][3] - M2 growth rate slightly declined to 8.2% in October, primarily due to base effects and reduced loan-generated deposits, while M1 growth rate fell to 6.2% [3] Mergers and Acquisitions - Mergers and acquisitions are seen as crucial tools for supporting economic transformation and achieving high-quality development, with a significant increase in market activity following the introduction of new policies in 2024 [4][5] - Historical trends show that the U.S. mergers and acquisitions market has experienced several waves, characterized by horizontal, vertical, diversification, and cross-border mergers [5] - The previous wave of mergers and acquisitions in China (2014-2015) positively impacted listed companies' performance, with a notable improvement in ROE following successful mergers [6] Economic Data Analysis - In October 2025, the industrial added value grew by 4.9% year-on-year, below expectations, while retail sales increased by 2.9% [7][8] - Seasonal factors and reduced working days contributed to the slowdown in industrial production, with certain sectors like transportation equipment manufacturing performing well [8] - Fixed asset investment showed a cumulative year-on-year decline of 1.7%, with manufacturing and infrastructure investments particularly affected by weak demand and policy implementations [10] Fund Research - The cross-border ETF market continues to see net inflows, with an expansion of the "Southbound ETF Connect" list, indicating growing interest in international investments [12][13] - The overall ETF market experienced a net inflow of 24.426 billion yuan, with significant contributions from cross-border ETFs [13][14] Industry Research - The medical and biological sector is witnessing a surge in flu cases, with the proportion of flu-like cases in the northern region reaching a four-year high, suggesting potential investment opportunities in diagnostics and vaccine production [16][17] - The light industry and textile sectors are benefiting from strong performance during the "Double Eleven" shopping festival, with apparel sales leading the growth [18][20]

Healthcare Policy - National Healthcare Security Administration held a series of discussions on the adjustment of the disease-based payment grouping scheme 3.0, involving over 70 representatives from medical institutions and industry associations [1] Drug and Medical Device Approvals - Shijiazhuang Pharmaceutical Group's application for the listing of Pertuzumab injection has been accepted by the National Medical Products Administration, targeting HER2-positive breast cancer [1] - Huason Pharmaceutical received a registration certificate for its special medical purpose formula food, Ganyimei®, designed for patients over 10 years old with strict fat restrictions and digestive absorption disorders [2] - United Imaging Healthcare's subsidiary obtained a medical device registration certificate for its color Doppler ultrasound diagnostic system, enhancing its product range across various market segments [3] - Yiling Pharmaceutical's application for the listing of Memantine Hydrochloride, a drug for treating moderate to severe Alzheimer's disease, has been approved [4] - Zhifei Biological's clinical trial application for a freeze-dried varicella inactivated vaccine has been accepted by the National Medical Products Administration [10] - Changchun High-tech's subsidiary received approval for a clinical trial of an acellular pertussis-diphtheria-tetanus combined vaccine for adolescents and adults [11] Capital Market Activities - Peking University Pharmaceutical announced the release of 34,615,386 shares from pledge, representing 51.52% of the pledged shares and 5.81% of the total share capital [5] - Kelun Pharmaceutical received approval for a registration of 4 billion yuan in ultra-short-term financing bonds, with a validity period of 2 years [6][7] - Baili Tianheng decided to delay its global offering and listing of H-shares due to current market conditions [8] - Aipeng Medical announced a plan for a shareholder to reduce holdings by up to 1% of total shares, citing personal funding needs [12] - Hendi Pharmaceutical's shareholders plan to collectively reduce their holdings by up to 2.33% of total shares for personal financial planning [13] Financial Adjustments - Baihua Pharmaceutical plans to use 1.91 billion yuan from its capital reserve to cover losses, primarily due to goodwill impairment from a previous major asset restructuring [14]

Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose over 4% following the acceptance of a new drug application for its product, a monoclonal antibody injection for HER2-positive breast cancer, by the National Medical Products Administration of China [1] Group 1: Company Developments - CSPC Pharmaceutical Group's subsidiary, CSPC Zhongqi Pharmaceutical Co., Ltd., has developed a monoclonal antibody injection, Pertuzumab, which has received regulatory acceptance for marketing [1] - The product is classified as a Class 3.3 therapeutic biological product and is indicated for HER2-positive breast cancer [1] - Pertuzumab is a recombinant humanized anti-HER2 monoclonal antibody injection that requires administration every three weeks [1] Group 2: Product Mechanism and Clinical Trials - The product works by specifically binding to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The application is primarily based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients [1] - Clinical trial results indicate that Pertuzumab is equivalent to the reference drug for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer, with comparable safety and tolerability [1]

Core Viewpoint - The stock of CSPC Pharmaceutical Group (01093) rose over 4% following the acceptance of a listing application for its drug, trastuzumab injection, by the National Medical Products Administration of China, aimed at treating HER2-positive breast cancer [1] Company Summary - CSPC Pharmaceutical Group's subsidiary, CSPC Zhongqi Pharmaceutical Co., Ltd., has developed trastuzumab injection, which is a recombinant humanized anti-HER2 monoclonal antibody [1] - The drug is administered once every three weeks and works by specifically binding to the extracellular dimerization domain II of HER2, blocking dimerization with other HER family members, thereby inhibiting the cell cycle and inducing apoptosis [1] - The application is based on a Phase III equivalence clinical trial involving early or locally advanced HER2-positive breast cancer patients, demonstrating that the drug is equivalent to the reference drug in terms of efficacy [1] Clinical Trial Summary - The clinical trial results indicate that trastuzumab injection is effective for neoadjuvant treatment of early or locally advanced HER2-positive breast cancer, showing equivalence to the reference drug [1] - The safety and tolerability of the drug are reported to be good and comparable to the reference drug [1]

Major Events - Hong Kong Stock Exchange (00388) plans to make a strategic investment in Xunqing Settlement Holdings Limited [1] - Lai Kai Pharmaceutical-B (02105) signs an exclusive licensing agreement with Qilu Pharmaceutical for LAE 002 (AFURESERTIB) in China [1] - TECHSTARACQ-Z (07855) is expected to inherit the company Tuda Tong's listing on the main board of the Stock Exchange on December 10 [1] - Superstar Legend (06683) intends to establish a joint venture with Yushu Technology to develop consumer-grade IP robots and IP derivative products [1] - Beijing Enterprises Holdings (00392) plans to acquire 100% equity of Beijing Beiran Special Equipment Inspection and Testing Co., Ltd. for 54.6 million yuan [1] - CSPC Pharmaceutical Group (01093) has its application for the marketing of Pertuzumab Injection accepted by the National Medical Products Administration [1] - Rongli Construction (09639) plans to collaborate with CATL to develop efficient energy storage systems and solutions [1] Operating Performance - BeiGene (06160) reports a net profit attributable to shareholders of 1.139 billion yuan for the first three quarters, turning from loss to profit year-on-year [1] - Tencent Music-SW (01698) reports a net profit attributable to equity holders of 2.15 billion yuan in the third quarter, a year-on-year increase of 36.0% [1] - Zhou Li Fu (06168) sees a 32% year-on-year increase in e-commerce revenue for the first ten months, with net profit rising 71% year-on-year [1] - China Resources Land (01109) reports a cumulative contract sales amount of approximately 169.6 billion yuan for the first ten months, a year-on-year decrease of 16.6% [1]

Core Viewpoint - The announcement indicates that the company's subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received the acceptance notice for the marketing application of the drug Patuzumab Injection from the National Medical Products Administration [1] Group 1 - The acceptance of the marketing application is a significant step for the company in advancing its product pipeline [1] - The drug Patuzumab Injection is likely to contribute to the company's revenue growth upon successful commercialization [1]

Core Viewpoint - New Horizon announced that its subsidiary, Shiyao Group Jushi Biopharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the marketing application of Pertuzumab injection, targeting HER2-positive breast cancer [1]. Group 1 - The marketing application for Pertuzumab injection has been accepted, indicating progress in the drug's approval process [1]. - Pertuzumab injection is a recombinant humanized anti-HER2 monoclonal antibody that specifically binds to the extracellular dimerization domain II of HER2, blocking the dimerization of HER2 with itself or other HER family members [1]. - The mechanism of action involves blocking the cell cycle and inducing apoptosis, which is crucial for treating HER2-positive breast cancer [1].

Group 1 - Longjian Co., Ltd. won a bid for a highway maintenance project in Heilongjiang with a contract value of 483 million yuan, accounting for 2.64% of the company's expected revenue for 2024 [1] - Transsion Holdings plans to issue H-shares and list on the main board of the Hong Kong Stock Exchange [1] - Good Home's controlling shareholder intends to reduce its stake by up to 2.7%, equivalent to no more than 39.4468 million shares [1][2] Group 2 - Xinhua Insurance reported a cumulative premium income of 181.973 billion yuan from January to October, representing a year-on-year growth of 17% [2][4] - Zhejiang Jiaokao is part of a consortium that plans to bid for a new urbanization project with an estimated total investment of 11.103 billion yuan [4] Group 3 - Changchun High-tech received approval for clinical trials of a vaccine for adolescents and adults [6] - XinNuoWei's application for the listing of Pertuzumab injection has been accepted, targeting HER2-positive breast cancer [8] - Dash Smart won a bid for an intelligent project at the new Huanggang Port inspection building, valued at 55.056 million yuan, which is 1.74% of its expected revenue for 2024 [8] Group 4 - Electronic City is involved in a lawsuit for debt recovery, with the amount in dispute estimated at 777 million yuan [9] - Haibo Technology signed a strategic cooperation agreement with CATL for a cumulative procurement of no less than 200 GWh of electricity from 2026 to 2028 [10] Group 5 - Renfu Pharmaceutical's HW231019 tablets have entered the second phase of clinical trials for postoperative pain relief [11] - Tonghua Dongbao received a drug registration certificate for Aspart Insulin injection from the Dominican Republic [11] Group 6 - Shaanxi Construction reported winning major projects worth a total of 1.016 billion yuan in October [12] - Fuzhou Environmental Protection plans to change its stock name to "Fuzhou Technology" [12] Group 7 - Panlong Pharmaceutical's gel patch for knee osteoarthritis has received approval for clinical trials [15] - Zhongyida's application for a specific stock issuance has been terminated by the Shanghai Stock Exchange [16] Group 8 - Zhizhong Home's controlling shareholder reduced its holdings of convertible bonds by 905,000 units, accounting for 13.51% of the total issued [19] - Haibo Co., Ltd. plans to establish a subsidiary with an investment of 1 billion yuan for high-end component projects [21] Group 9 - Caina Co. plans to use 57 million yuan of idle funds to purchase structured deposits [23] - Zhendong Pharmaceutical's new drug for acute ischemic stroke has entered the IIa phase of clinical trials [25] Group 10 - Weiman Sealing's overseas subsidiary plans to lease a factory in Saudi Arabia for 5 years at a total rent of approximately 54.039 million yuan [26] - Yiling Pharmaceutical's application for Memantine Hydrochloride has been approved for market entry [28] Group 11 - Dongfang Zhizao plans to acquire 70% of Saifu Machinery for 27.4887 million yuan [30] - JianKai Technology's actual controller intends to transfer 3% of the company's shares through inquiry [31] Group 12 - Rejing Bio plans to repurchase shares worth between 100 million and 200 million yuan [32] - Bangji Technology has decided to terminate a major asset restructuring project due to failure to reach an agreement [34] Group 13 - Huadong Pharmaceutical's application for the marketing license of a new drug has been accepted [36] - Zhonggu Logistics' shareholder plans to reduce its stake by up to 3% [38] Group 14 - Bohui Innovation's subsidiary received approval for a clinical trial of a vaccine for invasive infections [40] - Shannon Chip's shareholder pledged 0.27% of the company's shares for financing [42] Group 15 - Shanghai Petrochemical appointed a new general manager [44] - Jiaojian Co. plans to reduce the holdings of some directors and executives by up to 0.35% [46] Group 16 - Weiting Electric plans to raise no more than 300 million yuan through a private placement [47] - Zhongjin Irradiation plans to invest approximately 200 million yuan in an electronic accelerator manufacturing project [49] Group 17 - Tongxing Technology signed a framework agreement to invest 3.2 billion yuan in a sodium battery project [50] - Hongri Da plans to establish a subsidiary focused on semiconductor packaging [51] Group 18 - Shanghai Kaibao's new drug for acute ischemic stroke has received approval for clinical trials [53] - Yitong Century announced a change in its control structure, becoming a company without a controlling shareholder [55]