Investment Rating - The report does not explicitly state an investment rating for the industry Core Insights - The proportion of driver gene-negative non-small cell lung cancer (NSCLC) patients is approximately 31% in both China and the United States, indicating a significant market opportunity for treatments targeting this demographic [2][15] - The estimated market size for immune drugs used in first-line treatment of driver gene-negative NSCLC is projected to be around 7.5 billion CNY (approximately 1.1 billion USD) in China and 18 billion CNY (approximately 2.7 billion USD) in the United States by 2030 [2] - The current first-line treatment for advanced driver gene-negative NSCLC primarily relies on PD(L)-1 inhibitors combined with chemotherapy, but there are limitations in long-term efficacy and options for patients intolerant to chemotherapy [3] Summary by Sections Section 1: NSCLC Global Overview - Lung cancer is the leading cancer type globally, with new cases accounting for approximately 12% of all cancer cases in 2022, translating to about 2.5 million new lung cancer cases [10] - In China, lung cancer represents about 22% of new cancer cases, with approximately 1.06 million new cases in 2022 [10] Section 2: Market Potential for Driver Gene-Negative NSCLC - The report highlights the significant market potential for immune therapies in treating driver gene-negative NSCLC, with a focus on the limitations of current treatment options [2][3] Section 3: Next-Generation Immunotherapy Approaches - The report discusses the advancements in dual (multi) antibody therapies and immune-oncology (IO) combined with antibody-drug conjugates (ADC), emphasizing their potential to improve treatment outcomes for patients with driver gene-negative NSCLC [5][8] - The clinical data supporting these new therapies is expected to catalyze further investment and development in this area [5] Section 4: Treatment Guidelines Comparison - The report compares treatment guidelines for driver gene-negative NSCLC between the United States and China, noting differences in treatment stratification and recommended therapies [32][34] - The U.S. guidelines emphasize PD-L1 expression levels, while Chinese guidelines focus more on performance status (PS) [32][34] Section 5: Future Catalysts - Key upcoming clinical data releases and studies are highlighted as potential catalysts for investment opportunities in the sector, particularly regarding dual antibodies and ADC therapies [5][8]

证券研究报告 行业周报 礼来替尔泊肽全线爆发，2025年合计贡献365亿美元 生物医药行业强于大市（维持） 平安证券研究所生物医药团队 分析师： 叶寅投资咨询资格编号:S1060514100001邮箱：YEYIN757@PINGAN.COM.CN 倪亦道投资咨询资格编号:S1060518070001邮箱：NIYIDAO242@PINGAN.COM.CN 韩盟盟投资咨询资格编号:S1060519060002邮箱：HANMENGMENG005@PINGAN.COM.CN 裴晓鹏投资咨询资格编号:S1060523090002邮箱：PEIXIAOPENG719@PINGAN.COM.CN 何敏秀投资咨询资格编号:S1060524030001邮箱：HEMINXIU894@PINGAN.COM.CN 王钰畅投资咨询资格编号:S1060524090001邮箱：WANGYUCHANG804@PINGAN.COM.CN 曹艳凯投资咨询资格编号:S1060524120001邮箱：CAOYANKAI947@PINGAN.COM.CN 张梦鸽投资咨询资格编号:S1060525070003邮箱：ZHANGMENGGE752@PINGA ...

Core Insights - Bristol Myers Squibb (BMY) has partnered with Janux Therapeutics to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen across multiple cancer types [2] - Janux is set to receive up to $50 million in upfront and near-term milestone payments, with potential additional milestones totaling approximately $800 million, along with tiered royalties on global product sales [3] - BMY will lead clinical development and global commercialization after the IND submission, while Janux will remain involved through the first phase I study [4] Collaboration and Development - BMY's collaboration with Microsoft aims to enhance early detection of lung cancer using AI-powered radiology solutions [4] - In 2025, BMY partnered with BioNTech for the co-development of the investigational bispecific antibody pumitamig (BNT327) for various solid tumor types [5] - Interim results from a phase II study of pumitamig in combination with chemotherapy for triple-negative breast cancer showed encouraging antitumor activity and a manageable safety profile [6][7] Competitive Landscape - BMY competes in the oncology space with major players like Merck and Pfizer, with Merck's Keytruda being a dominant drug in immuno-oncology [9] - Merck is developing bispecific antibodies targeting PD-1 and VEGF, while Pfizer has a diverse oncology portfolio including ADCs and bispecifics [10][13] Financial Performance and Valuation - BMY shares have increased by 25.4% over the past six months, outperforming the industry growth of 22.8% [15] - The company is trading at a price/earnings ratio of 9.02x forward earnings, which is lower than the large-cap pharma industry's average of 18.18x [17] - The Zacks Consensus Estimate for BMY's 2025 EPS has decreased to $6.33 from $6.51 over the past 60 days, while the estimate for 2026 has increased [19]

Core Insights - Bristol Myers Squibb (BMY) showcased its promising pipeline at the 44th Annual J.P. Morgan Healthcare Conference, emphasizing multi-billion-dollar potential candidates [1][9] Pipeline Candidates - Key pipeline candidates include milvexian (oral factor XIa inhibitor), admilparant (LPA1 antagonist), pumitamig (PD-L1 x VEGF-A bispecific antibody), and iberdomide & mezigdomide (oral CELMoD protein degraders) [1] - Milvexian is being developed in partnership with Johnson & Johnson for atrial fibrillation and secondary stroke prevention, with data expected in 2026 [2] - Admilparant is under evaluation for idiopathic pulmonary fibrosis, with data from the ALOFT-IPF study anticipated later this year [3] - Pumitamig is being assessed for various solid tumor types and has received orphan drug designation for small-cell lung cancer, with eight registrational trials expected to start by year-end [4] - Iberdomide is being studied for relapsed or refractory multiple myeloma, showing significant improvement in minimal residual disease negativity rates in late-stage studies [5] Label Expansion and Market Strategy - BMY is expanding the label for schizophrenia drug Cobenfy, which has shown initial sales of $105 million in the first nine months of 2025, and is being evaluated for Alzheimer's-related psychosis and agitation [6][7] - The successful development of these pipeline assets and label expansions will significantly enhance BMY's portfolio amidst challenges from generic competition affecting legacy products [7] Competitive Landscape - BMY is focused on oncology, competing with major players like Merck and Pfizer, which have established oncology portfolios and are also developing bispecific antibodies targeting PD-1 and VEGF [8][10][12] Financial Performance - BMY shares have increased by 11.3% over the past six months, compared to the industry's growth of 16.3% [14] - The company is trading at a price/earnings ratio of 9.08x forward earnings, which is lower than the large-cap pharma industry's average of 17.74x [16] - The Zacks Consensus Estimate for 2025 EPS has slightly decreased to $6.48, while the estimate for 2026 has increased [17]

COVID-19 Vaccine Impact - BioNTech distributed over 5 billion COVID-19 vaccine doses to over 180 countries and territories[7, 11] - A real-world study of 27 million adults showed a 74% lower risk of death from severe COVID-19 over 45 months in vaccinated individuals[11] - BioNTech maintained leadership with over 50% market share in the global COVID-19 vaccine market during the fall 2025 vaccination season[9, 11] Financial Performance and Strategy - BioNTech expects its revenues for the full 2025 financial year to be in the range of €2600 - €2800 million[9] - BioNTech has €172 billion in cash, cash equivalents, and securities as of December 31, 2025[9, 17] - BioNTech anticipates a modest decline in Comirnaty revenues in 2026 compared to 2025[18] Oncology Pipeline and Development - BioNTech has over 25 ongoing Phase 2 & 3 oncology trials[7, 9] - There are 12+ combination trials with chemotherapy and 10+ novel-novel combinations trials ongoing with Pumitamig[42] - Gotistobart Phase 3 data shows a 54% reduction in the risk of death compared with docetaxel in CPI-Treated Squamous NSCLC[62]

Investment Rating - The report does not explicitly provide an investment rating for the biopharmaceutical sector [5]. Core Insights - The biopharmaceutical sector is experiencing significant activity with multiple companies focusing on innovative drug development, particularly in the area of siRNA targeting INHBE, which shows promise for fat reduction without muscle loss [3][24]. - The report highlights the recent performance of new drug stocks, with notable gains from companies such as Saint Nor Pharmaceutical (+30.88%) and Dongyao Pharmaceutical (+16.37%), while companies like Kexin Pharmaceutical (-14.19%) and Rongchang Biotechnology (-10.09%) faced declines [1][15]. - There is an expectation of multiple catalysts in the sector, including academic conferences and data releases, which could drive further interest and investment [2]. Weekly New Drug Market Review - From December 8 to December 14, 2025, the new drug sector saw significant stock movements, with the top five gainers and losers listed [1][15]. - The report notes that there were no new drug approvals during this week, but 11 new drug applications were accepted [4][31]. Weekly New Drug Industry Analysis - Wave Life Sciences has reported promising initial data for its siRNA drug WVE-007, which targets INHBE and demonstrates potential for reducing visceral fat while preserving muscle mass [3][24]. - The report indicates that several companies, both globally and domestically, are actively developing siRNA drugs targeting INHBE, with five drugs already in clinical development [27][28]. Weekly New Drug Approval & Acceptance Status - No new drug or new indication approvals were reported this week, but 11 new drug applications were accepted [4][31]. - A total of 55 new drug clinical applications were approved, and 47 new drug clinical applications were accepted during the week [9][34]. Key Events in Domestic Market - Significant events include the approval of new drugs by companies such as Zhengda Tianqing and Nuo Cheng Jian Hua, which received approval for their respective new drugs [10][11]. Key Events in Overseas Market - Noteworthy overseas events include Eli Lilly's announcement of positive results from its TRIUMPH-4 Phase 3 trial and the FDA's approval of a gene therapy by Fondazione Telethon [11].

Core Viewpoint - BioNTech SE reported a significant earnings miss while exceeding revenue expectations, highlighting challenges in its financial performance and the impact of its partnerships on revenue generation [2][6]. Financial Performance - BioNTech reported an earnings per share (EPS) of -$0.14, missing the estimated EPS of $0.75, and showing a decline from the previous year's EPS of $0.81 [2][6]. - The company exceeded revenue expectations with $1.78 billion, compared to the estimated $1.09 billion, largely due to its partnership with Bristol-Myers Squibb [2][6]. - The financial metrics indicate challenges, with a negative price-to-earnings (P/E) ratio of -62.09 and an earnings yield of -1.61% [5]. Revenue Sources - Revenue gains were attributed to ongoing sales of the Comirnaty COVID vaccine and upfront payments from Bristol-Myers Squibb, although a decrease in COVID-19 vaccine sales volumes partially offset these gains [3][6]. Cost Structure - Research and development expenses increased to 564.8 million euros, while selling, general, and administrative expenses decreased to 148.5 million euros [4]. Financial Stability - BioNTech maintains a low debt-to-equity ratio of 0.015 and a strong current ratio of 8.61, indicating financial stability and a robust ability to cover short-term liabilities [5][6]. Pipeline Development - The oncology pipeline, led by pumitamig, is progressing but currently lacks best-in-class data or approvals, creating uncertainty regarding future revenue potential [4].

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were EUR 1,519 million, an increase from EUR 1,245 million in Q3 2024, primarily driven by a $700 million recognition from the BMS collaboration [34] - The net loss for Q3 2025 was EUR 29 million, compared to a net income of EUR 198 million in the same period last year, mainly due to settlement disputes [36] - Cash, cash equivalents, and security investments totaled EUR 16.7 billion at the end of Q3 2025, including a $1.5 billion upfront payment from BMS [36] Business Line Data and Key Metrics Changes - The company is focusing on two priority pan-tumor programs: pumitamig and mRNA cancer immunotherapies, with multiple ongoing phase II and III trials [39] - Significant progress was made in advancing pumitamig, with global registration trials in lung cancer and plans to initiate a TNDC phase III trial [8][9] Market Data and Key Metrics Changes - The company continues to see stable market share and pricing for its COVID-19 vaccine, COMIRNATY, with U.S. vaccination rates around 20% [81] - The updated revenue guidance for 2025 was increased to EUR 2.6 billion - EUR 2.8 billion, mainly due to the BMS collaboration [37] Company Strategy and Development Direction - The company aims to build a global immunotherapy powerhouse, focusing on a diversified clinical pipeline that includes mRNA immunotherapies and next-generation immunomodulators [5][6] - The strategy includes a three-wave plan for pumitamig, focusing on establishing foundational indications, expanding opportunities, and elevating clinical impact through novel combinations [14][15] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of generating meaningful data across oncology programs to steer late-stage decisions and maintain financial discipline [39] - The company is committed to transforming scientific advances into late-stage progress in priority oncology programs while preparing for commercialization [11] Other Important Information - The company hosted its second AI day, showcasing AI-based approaches for personalized therapy development [10] - The company plans to present additional clinical data at the upcoming annual Innovation Series R&D Day event on November 11 [39] Q&A Session Summary Question: Market opportunity for MSS-CRC and first-line gastric cancer - Management highlighted that both indications are high medical need areas, and the combination of VEGF-A and PD-L1 blocking has potential for improved clinical benefit [44][45] Question: Delay in BLA filing for BNT323 - The delay is due to ongoing discussions with the FDA regarding additional data needs, with plans to submit in 2026 [52][71] Question: Strategy for pumitamig's establishment and elevation - The three-wave strategy is designed to focus on speed to market while generating data in combination studies [56][57] Question: Phase II details for BNT327 in triple-negative breast cancer - Management confirmed that efficacy, safety, and dose data will be presented at SABCS [62] Question: Collaboration with Bristol Myers Squibb - The collaboration involves a Joint Steering Committee for decision-making on clinical development, allowing flexibility for both partners [88][89]

BioNTech's Vision and Strategy - BioNTech aims to build a global immunotherapy powerhouse translating science into survival[13] - BioNTech has distributed 5 billion doses of COVID-19 vaccine globally[12] - BioNTech is leveraging AI to pioneer personalized immunotherapies[62] InstaDeep's AI Capabilities and Technologies - InstaDeep's AI supercomputer, Kyber, has ~500 PetaFLOPS of Nvidia H100 GPUs and 86,000 CPU Cores[105] - InstaDeep's AI training platform, AIChor, has seen +15,000 experiments per month in 2025 with +75% GPU usage[109] - Nucleotide Transformer (NTv3) pre-trained on genomes from >150,000 species and post-trained on >17,000 functional tracks across 16 species[154] AI-Driven Innovation in Genomics and Proteomics - InstaNovo V2 achieves up to 2x the number of identifications in peptide sequencing[263] - AI-assisted tissue annotation tool increased pathologist efficiency fivefold (5x)[265] - AI pipeline achieves an average 50,000-fold TCR binding enhancement increase over WT[345]

Core Insights - Bristol Myers Squibb (BMY) announced positive data from the late-stage study on iberdomide for patients with relapsed or refractory multiple myeloma (RRMM) [1][8] - The phase III EXCALIBER-RRMM study demonstrated statistically significant improvement in minimal residual disease (MRD) negativity rates compared to the control arm [2][8] - The study is designed to assess dual-primary endpoints of MRD negativity and progression-free survival (PFS), with additional secondary endpoints including overall survival (OS) and health-related quality of life [3] Study Details - The EXCALIBER-RRMM study is a multicenter, two-stage, randomized, open-label trial evaluating iberdomide in combination with Darzalex and dexamethasone versus Darzalex, bortezomib, and dexamethasone [1][3] - The safety profile of iberdomide in combination with daratumumab and dexamethasone is consistent with previous studies, and the trial will continue to evaluate PFS and OS [4] - BMY plans to discuss the results with health authorities as iberdomide represents a novel class of medicines called CELMoDs, which may change the treatment landscape for multiple myeloma [5] Portfolio Expansion - BMY's Growth Portfolio includes drugs such as Opdivo, Orencia, and Yervoy, as the company seeks to expand its pipeline due to the adverse impact of generics on its legacy portfolio [6] - BMY's shares have decreased by 17.8% year-to-date, while the industry has grown by 5.2% [6] Collaboration and New Developments - BMY is collaborating with BioNTech on the development of pumitamig, a bispecific antibody for extensive-stage small cell lung cancer, which has shown a 76.3% confirmed objective response rate in interim data [9][10] - The approval of Cobenfy for schizophrenia broadens BMY's portfolio and validates its acquisition of Karuna Therapeutics, representing a new pharmacological approach to treating schizophrenia [11][12]