Core Viewpoint - Sanofi China has received approval from the National Medical Products Administration for its quadrivalent influenza virus split vaccine for the 2025-2026 flu season [1] Company Summary - Sanofi China announced the approval of its quadrivalent influenza vaccine, indicating a significant step in its product offerings for upcoming flu seasons [1]

Novavax's Corporate Strategy - Novavax is shifting its business model to focus on R&D and diversified partnerships[7, 8] - The company aims to drive value through in-house early-stage R&D and strategic partnerships[6, 9] - Novavax is establishing a lean operating model to drive shareholder value[59] Sanofi Partnership - Sanofi made a minority equity investment (less than 5%) in Novavax[16] - Novavax received a $500 million upfront payment from Sanofi in Q2 2024, with $424 million recognized in 2024 and $76 million amortized through 2026[18] - Novavax is eligible for up to $700 million in milestones from Sanofi[18] COVID-19 and Influenza Vaccines - COVID-19 hospitalization rates are approximately 4 times higher than those for influenza[20] - COVID-19 vaccine coverage rates are less than half of influenza vaccine rates among US adults 18+ in the 2023-24 season (22% vs 45%)[22, 23] - Nuvaxovid recipients experienced approximately 39% fewer symptoms compared to mRNA vaccine recipients[25] Matrix-M Adjuvant and Partnerships - Novavax is eligible to receive up to $200 million in launch and sales milestones plus mid-single digit royalties under the Matrix-M license agreement[19] - Novavax's COVID-Influenza Combination (CIC) vaccine and stand-alone flu vaccines are in Phase 3 trials, with initial cohort data showing robust immune responses and good tolerability[45, 54]

Core Insights - Sanofi's Specialty Care division is positioned for significant growth, focusing on immunology, oncology, neurology, and rare diseases [3][4] - The company anticipates dupilumab to achieve a compound annual growth rate (CAGR) in the double digits from 2023 to 2030, potentially generating around EUR 22 billion by 2030 [4] Company Overview - Sanofi has streamlined its business units from four to three following the sale of its Consumer Health Opella, now comprising General Medicines, Vaccines, and Specialty Care [3] - The Specialty Care business unit is expected to drive growth through recently launched products such as ALTUVIIIO and Qfitlia, alongside the expanding indications for SARCLISA in oncology and multiple myeloma [4]

Core Insights - The FDA approved Merck's Enflonsia to protect infants from respiratory syncytial virus (RSV), competing with Sanofi and AstraZeneca's Beyfortus [1][4] - Merck plans to launch Enflonsia ahead of the RSV season, with orders expected to start in July [2] - The approval provides a new treatment option for RSV, which causes significant mortality and hospitalization among infants [3] Company Developments - Merck aims to ensure availability of Enflonsia in the U.S. before the RSV season to alleviate the burden on families and healthcare systems [4] - Enflonsia is a preventative monoclonal antibody that can be administered to infants regardless of weight, offering dosing convenience [5] - Sanofi is increasing the supply of Beyfortus, which generated €1.7 billion ($1.8 billion) in sales last year [6] Industry Context - Other companies, including Pfizer, GSK, and Moderna, offer RSV vaccines, but these are limited to adults and pregnant women [6] - A meeting of CDC vaccine advisors is scheduled for June 25 to 27 to discuss recommendations for RSV shots and other immunizations [7] - In clinical trials, Enflonsia reduced RSV-related hospitalizations by over 84% and lower respiratory infections requiring medical attention by more than 60% compared to a placebo [8]

Investment Rating - The investment rating for the industry is "Positive" and is maintained [9] Core Insights - CEACAM5 is a member of the immunoglobulin superfamily adhesion molecules, highly expressed in various malignancies such as colorectal cancer, gastrointestinal cancer, and lung cancer, playing a significant role in tumor occurrence, invasion, and metastasis [2][6][18] - With the first clinical trial of SAR408701 by Sanofi entering Phase III, CEACAM5 ADC has become a popular development direction for targeted therapy drugs [2][28] - Currently, there are 8 CEACAM5-targeted ADCs in development globally, with 6 having entered clinical stages, showcasing a trend of diverse technological pathways and distinctive mechanisms among major pharmaceutical companies [2][8] Summary by Sections CEACAM5 as a Target - CEACAM5 is recognized as a high-expression tumor target, with its drug development potential accelerating due to the emergence of various therapeutic approaches, including ADCs, monoclonal antibodies, bispecific antibodies, CAR-T cell therapies, and therapeutic vaccines [6][28] CEACAM5 ADC Development - The heat around CEACAM5 ADC is rising, with the design of effective connections being key to overcoming challenges related to its weak internalization capacity [7][32] - The development focus is shifting towards optimizing linkers and payload systems to enhance stability and ensure precise release in the tumor microenvironment [7][32] Competitive Landscape - Major pharmaceutical companies are actively positioning themselves in the CEACAM5 ADC space, with notable developments from Sanofi, Merck, Innovent, and BeiGene, each showcasing unique design strategies and therapeutic potentials [8][50][58][61] - Sanofi's SAR408701, despite facing setbacks, continues to explore its potential in other cancer types, while Merck's M9140 is the first to utilize a topoisomerase I inhibitor in this context [8][50] Investment Perspective - The report suggests that the ongoing innovation in drug development, particularly in the context of CEACAM5-targeted therapies, presents significant investment opportunities, especially for companies with strong cash flows and innovative capabilities [64]

Investment Rating - The report maintains an investment rating of "Outperform" for the biopharmaceutical sector [7]. Core Insights - The PD-(L)1 monoclonal antibody market is vast, with multiple companies developing PD-1 class upgrade products, including PD-1/VEGF bispecific antibodies and PD-1/IL-2 bispecific antibodies. The IBI363 from Innovent Biologics is expected to be the next significant PD-1 upgrade product following the PD-1/VEGF bispecific antibody [2][21]. - IBI363 has shown excellent data in the treatment of wild-type NSCLC and colorectal cancer, indicating its potential to expand into first-line treatment markets based on its performance in the IO resistant market [2][22]. - The competitive landscape for PD-1/IL-2 bispecific antibodies is favorable for IBI363, as it is the only PD-1/IL-2α bispecific antibody currently in Phase II clinical trials, while most competitors are in earlier stages [3][25]. Summary by Sections Weekly New Drug Market Review - From June 2 to June 6, 2025, the top five companies in the new drug sector by stock performance were Junsheng Tai Pharmaceutical-B (24.29%), Zai Lab (23.28%), Innovent Biologics (18.08%), Maiwei Biopharma (17.72%), and Shenzhou Cell (17.24%). The bottom five were Deqi Pharmaceutical-B (-12.68%), JACOB-B (-11.90%), Heptares Therapeutics-B (-10.86%), CanSino Biologics-B (-10.75%), and WuXi AppTec-B (-8.54%) [1][17]. Weekly New Drug Industry Analysis - The report highlights the potential of IBI363 as a next-generation PD-1 upgrade product, with promising data presented at ASCO 2025. The drug is expected to target multiple tumor types and expand into first-line treatment markets [2][21]. Weekly New Drug Approval & Acceptance Status - This week, 20 new drug or new indication applications were approved in China, including drugs from Zai Lab and Shenzhen Xinlitai. Additionally, 11 new drug applications were accepted, including those from MSD and Eli Lilly [4][28]. Weekly New Drug Clinical Application Approval & Acceptance Status - There were 21 new drug clinical application approvals and 43 new drug clinical applications accepted in the domestic market this week [5].

Core Insights - Dupixent has shown a significant efficacy in treating atopic dermatitis in patients with skin of color, achieving a 75% or greater improvement in overall disease severity in over 76% of treated patients [1][5] - The DISCOVER trial results highlight the importance of understanding chronic diseases in underserved populations, particularly in communities of color [1][2] Group 1: Clinical Trial Results - The DISCOVER Phase 4 trial involved 120 patients with atopic dermatitis and skin of color, with 82% being Black [2][5] - At 24 weeks, 76% of patients achieved a ≥75% improvement in overall disease severity (EASI-75), and 53% reported clinically meaningful improvement in itch [5][7] - Patients experienced a 53% reduction in post-inflammatory hyperpigmentation, with scores decreasing from 5.1 (moderate/marked) to 2.4 (mild) [5][6] Group 2: Safety Profile - The safety results from the DISCOVER trial were consistent with Dupixent's known safety profile, with an overall adverse event rate of 42% [3] - Common adverse events included headache (3%), upper respiratory tract infection (2%), and conjunctivitis (3%) [3] Group 3: Disease Characteristics - Atopic dermatitis presents differently in patients with skin of color, often leading to misdiagnosis or underestimation of disease severity [4] - Patients with darker skin tones are more likely to experience severe skin dryness, dyspigmentation, and hardened skin lesions compared to those with lighter skin [4] Group 4: Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, addressing type 2 inflammation [8] - It has received regulatory approvals in over 60 countries for various indications, including atopic dermatitis and asthma, with over 1 million patients treated globally [9][11]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Sanofi and its officers or directors [1] Group 1: Company Performance - On May 30, 2025, Sanofi released mixed results from a Phase 3 program for itepekimab, an antibody therapy for chronic obstructive pulmonary disease, with the AERIFY-1 trial meeting its primary endpoint, while the AERIFY-2 trial did not [2] - Following the announcement, Sanofi's American Depositary Receipt (ADR) price dropped by $2.98, or 5.69%, closing at $49.37 per ADR on the same day [3] Group 2: Legal Investigation - The investigation by Pomerantz LLP is aimed at determining if there were any fraudulent activities or misconduct related to Sanofi's business practices [1] - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4]

Core Insights - GSK has appointed Dr. Sanjay Gurunathan from Sanofi as the head of its vaccine and infectious disease R&D department, indicating a strategic shift in response to challenges in its vaccine business [1][5] - Gurunathan brings over 20 years of experience from Sanofi, where he held significant roles in vaccine development and regulatory approval [3][4] Company Developments - Gurunathan will be based in Boston and report directly to GSK's Chief Scientific Officer, Tony Wood, overseeing the innovation and development of GSK's extensive vaccine and infectious disease product line [3] - The previous head of this department, Phil Dormitzer, left GSK in December 2023 to start a consulting firm [3] Industry Context - The recent talent exchange between GSK and Sanofi reflects a competitive landscape in the global vaccine industry, which is undergoing strategic adjustments [5] - GSK's vaccine sales have faced pressure, with a reported 8% year-over-year decline in Q1 2025, amounting to £2.1 billion (approximately $2.8 billion) [5] Market Challenges - The CDC's restrictive immunization guidelines have limited the market potential for GSK's RSV vaccine, Arexvy, which is now only recommended for specific high-risk groups aged 60 and above [6] - GSK has adjusted its full-year vaccine revenue expectations to a single-digit decline due to these sales challenges [5] Future Outlook - GSK's vaccine pipeline includes promising projects targeting COVID-19, HIV, and influenza, indicating potential for future growth [7] - Gurunathan's role will likely focus on optimizing the R&D pipeline and enhancing the market presence of existing products, which is crucial for GSK's strategic direction in the evolving vaccine market [7]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices involving Sanofi and its officers or directors [1] Group 1: Company Performance - On May 30, 2025, Sanofi released mixed results from a Phase 3 program for itepekimab, an antibody therapy for chronic obstructive pulmonary disease, with the AERIFY-1 trial meeting its primary endpoint while the AERIFY-2 trial did not [3] - Following the announcement, Sanofi's American Depositary Receipt (ADR) price dropped by $2.98, or 5.69%, closing at $49.37 per ADR on the same day [3] Group 2: Legal Investigation - The investigation by Pomerantz LLP is focused on whether Sanofi and certain officers or directors have engaged in securities fraud or other unlawful business practices [1] - Investors are encouraged to contact Pomerantz LLP for more information regarding the class action [2]