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]

Core Points - Sanofi is launching its global employee shareholder plan, Action 2025, on June 10, 2025, for approximately 70,000 employees across 55 countries, marking the program's 11th year [1][2] - In 2024, over 32,000 employees, representing 40% of the workforce, participated in the program, and nearly 90,000 current or former employees now hold about 2.55% of Sanofi's capital [1][2] Employee Participation - The subscription price for shares will be set at €72.97, which is a 20% discount based on the average of the 20 opening prices from May 7 to June 3, 2025 [2] - Employees can purchase up to 1,500 shares, with a maximum payment not exceeding 25% of their gross annual salary, and for every five shares subscribed, one free matching share will be offered, up to a maximum of four matching shares per employee [2][3] Subscription Details - Eligible employees must have three months of employment by the closing date of the offer period, with the subscription period running from June 10 to June 30, 2025 [3] - The total number of shares offered is limited to 1% of Sanofi's share capital as of January 29, 2025, after accounting for a previous capital increase reserved for employees [4] Share Characteristics - The new shares will be fully fungible with existing shares and will acquire dividend rights starting January 1, 2025, with voting rights exercised directly by employees [5] - Shares subscribed in France must be held for approximately five years, while those subscribed outside France may have a holding period of three years, depending on local regulations [6] Trading and Compliance - Admission of the shares to trading on the Euronext Paris market will be requested after the completion of the capital increase [7] - The offer will only be made in countries where all necessary registration and notification procedures have been completed [9]

Core Insights - Sanofi's investigational BTK inhibitor, rilzabrutinib, has received orphan drug designation from the FDA for sickle cell disease (SCD), marking its fourth such indication [1][2][6] - Rilzabrutinib aims to reduce vaso-occlusive crises by modulating immune responses and has shown promising results in preclinical studies [1][3] - SCD affects over 100,000 individuals in the U.S., leading to severe complications and a significantly reduced life expectancy [4] Company Developments - Rilzabrutinib is currently under FDA review for immune thrombocytopenia (ITP), with a decision expected by August 29, 2025 [6][10] - The drug has also received orphan drug designation for treating warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD), both of which have significant unmet medical needs [7][9] - Sanofi's acquisition of Principia Biopharma included rilzabrutinib, which is also being developed for other immune-mediated diseases [11] Clinical Data - Preclinical studies indicate that rilzabrutinib effectively reduced vaso-occlusion and inflammation in SCD mouse models [3][6] - Phase IIb studies for wAIHA have shown clinically meaningful outcomes, while phase IIa studies for IgG4-RD demonstrated reductions in disease flare and other markers [8]

Core Insights - New data from clinical studies support the subcutaneous administration of Sarclisa via an on-body injector, demonstrating non-inferior efficacy and safety compared to intravenous infusion [1][5][6] Group 1: Clinical Study Findings - The IRAKLIA phase 3 study showed very good partial response (VGPR) rates of 46.4% for Sarclisa SC-Pd and 45.9% for Sarclisa IV-Pd, indicating non-inferiority [5] - The objective response rate (ORR) for Sarclisa SC-Pd was 71.1% compared to 70.5% for Sarclisa IV-Pd, establishing non-inferiority [7] - The overall safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower rate of systemic infusion reactions (1.5% vs. 25%) [12][8] Group 2: Patient Experience and Administration - The on-body injector (OBI) is expected to enhance patient experience by providing greater convenience and flexibility, leading to higher patient satisfaction scores [2][9] - 70% of patients treated with Sarclisa SC-Pd reported satisfaction with their injection, compared to 53.4% in the IV-Pd group [12] - The OBI allows for a hands-free administration process, potentially reducing the physical burden on healthcare providers [2][11] Group 3: Future Directions and Regulatory Submissions - Data from the IRAKLIA and IZALCO studies will form the basis for global regulatory submissions for Sarclisa SC administration [6][14] - Sanofi is also exploring Sarclisa SC administration in front-line treatment settings through additional studies [14] - The IRAKLIA study's abstract was selected for the 2025 Best of ASCO program, highlighting its significance in the field [14]

Core Insights - New clinical studies demonstrate the efficacy and safety of Sarclisa administered subcutaneously via an on-body injector (OBI) for relapsed or refractory multiple myeloma (R/R MM) [1][7][10] - The studies presented at the ASCO Annual Meeting show that the OBI method offers non-inferior efficacy compared to traditional intravenous (IV) administration [1][5][10] Study Details - The IRAKLIA phase 3 study is a pivotal non-inferiority trial comparing Sarclisa SC via OBI with Sarclisa IV, both combined with pomalidomide and dexamethasone in adult patients with R/R MM [5][17] - The study reported an overall response rate (ORR) of 71.1% for Sarclisa SC-Pd versus 70.5% for Sarclisa IV-Pd, establishing non-inferiority [8] - The safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower incidence of systemic infusion reactions (1.5% vs. 25%) [9][13] Patient Experience - The OBI is designed to enhance patient comfort and satisfaction, with 70% of patients preferring the OBI over manual injection [13][14] - Patient satisfaction scores were significantly higher for the OBI method, with 74.5% of patients expressing a preference for it [14][15] Future Directions - Sanofi is exploring further applications of Sarclisa SC via OBI in various treatment settings, including front-line therapy for newly diagnosed multiple myeloma patients [15][20] - Data from the IRAKLIA and IZALCO studies will support global regulatory submissions for the OBI delivery method [7][15]

古根海姆：将赛诺菲目标价从108欧元上调至110欧元。 ...