投资界6月24日消息，近日，太平医疗健康基金完成了对海南先声再明医药股份有限公司的投资。先声 再明是国内制药龙头企业先声药业集团（02096.HK）旗下抗肿瘤创新药公司，具有高效的临床开发能 力和丰富的商业化经验。此次投资将进一步支持先声再明发挥创新优势，参与肿瘤免疫治疗的国际竞争 与合作，推动先进产品开发以满足全球临床需求。 先声再明自主研发并构建了蛋白质工程平台、T cell engager （T细胞衔接器）、NK cell engager（NK细 胞衔接器）、ADC（抗体偶联药物）、PROTAC（蛋白降解靶向嵌合体）、AI辅助分子设计等研发技 术平台。其独立自主的工艺生产能力已满足中 美两国GMP（良好生产规范）生物药生产体系标准。目 前公司已有4款核心创新药物科赛拉®、恩维达®、恩度®、恩立妥®上市并实现商业化，涵盖多种实体 瘤的治疗，继恩度®之后2024年科赛拉®和恩立妥®也成功进入国家医保目录，先声再明有望成长为研 发、生产和销售全方位领先的创新型抗肿瘤药企。 此前，2025年1月先声再明与全球生物制药公司艾伯维就SIM0500 （一款人源化GPRC5D-BCMA-CD3三 特异性抗体，由先声再明 ...

Financial Data and Key Metrics Changes - First quarter revenues grew by 9% year over year, with non-GAAP EPS increasing by 24% [5] - The revenue from Repatha reached $656 million, up 27% year over year [5] - The rare disease portfolio generated over $1 billion in product sales in the first quarter [7] - The biosimilars portfolio generated $735 million in product sales, up 35% year over year [9][10] - Operating margin is guided to be around 46% for the year, down from 47% last year due to increased R&D opportunities [32] Business Line Data and Key Metrics Changes - General medicine products, including Repatha and Evenity, showed strong growth, with Repatha being a multibillion-dollar product [5][16] - TESPIRE in inflammation grew by 65% year over year [7][19] - The oncology segment, particularly the T cell engager platform, saw a 52% growth in BLINCYTO [8][16] - The rare disease segment continues to show strength with products like Euplisna and KRYSTEXXA [18] Market Data and Key Metrics Changes - Cardiovascular disease remains a leading cause of mortality, driving growth for Repatha [5] - The market for obesity treatments is vast, with estimates suggesting over a billion people affected globally [46] - The company is optimistic about expanding its presence in the rare disease market, particularly with new launches [18][60] Company Strategy and Development Direction - The company's strategy focuses on execution in both the end market portfolio and the advancing pipeline [16][23] - Significant capital allocation is planned for expanding manufacturing capabilities, with $2.3 billion in CapEx for the year [21] - The company is actively engaging in business development opportunities, including collaborations and acquisitions [26][28] Management's Comments on Operating Environment and Future Outlook - Management is closely monitoring the policy and macro environment, including tariffs and drug pricing [10][32] - The company is optimistic about its innovation pipeline and believes it can navigate the current challenges effectively [30][33] - There is a strong focus on patient access and value, with ongoing engagement with policymakers [28][30] Other Important Information - The company is preparing for a PDUFA date for Euplisna in generalized myasthenia gravis [7][60] - Upcoming data presentations at the American Diabetes Association meeting will provide insights into the Meritide program [13][34] Q&A Session Summary Question: What are the key priorities for the company today and what is the forward strategy? - The key strategy is focused on execution in the end market portfolio and rapidly advancing pipeline [16] Question: How important is business development as a lever for the company? - The company maintains an open approach to business development, looking at all opportunities for innovation [26] Question: How is the company engaging with policymakers regarding drug pricing? - The company is actively engaged with policymakers to advocate for innovation and patient access [28] Question: What is the outlook for the obesity market and how will Meritide be positioned? - The obesity market is large and underpenetrated, with Meritide expected to compete effectively across various settings [46][48] Question: What are the commercial opportunities for the recently launched drugs? - The company sees significant potential in IgG4 mediated diseases and myasthenia gravis, with strong efficacy profiles [60][61]

Cullinan Therapeutics Licensing of velinotamig (BCMAxCD3) from Genrix Bio June 2025 © CULLINAN THERAPEUTICS, INC. ALL RIGHTS RESERVED. CONFIDENTIAL AND PROPRIETARY Important Notice and Disclaimers This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding the potential benefits of, and pl ...

Cullinan Therapeutics (CGEM) Update / Briefing June 04, 2025 04:30 PM ET Speaker0 Good afternoon. Thank you for standing by and welcome to the Cullinan Therapeutics Generics Bio License Agreement Conference Call. As a reminder, this call is being recorded. A slide deck that you may find helpful while listening to this call is available on the Events section of Investor Relations website @investors.cullinantherapeutics.com. It is now my pleasure to turn the call over to Nick Smith, Head of Investor Relations ...

Core Insights - Cullinan Therapeutics has advanced its leadership in T cell engager (TCE) development for autoimmune diseases, with both a CD19 TCE and BCMA TCE in its pipeline [1] - The company has strengthened its portfolio of autoimmune programs, aiming to address a broader range of diseases while ensuring cash runway into 2028 [1][5] - Cullinan has entered into an agreement with Genrix Bio for an exclusive global license to velinotamig, a BCMAxCD3 bispecific T cell engager, which has shown promising efficacy in treating relapsed/refractory multiple myeloma [2][3] Company Developments - Velinotamig has demonstrated potential best-in-class efficacy at the Phase 2 target dose in nearly 50 patients with relapsed/refractory multiple myeloma [2] - The agreement includes an upfront license fee of $20 million, with potential future payments of up to $292 million in development and regulatory milestones, plus up to $400 million in sales-based milestones [4] - Cullinan plans to leverage data from Genrix's Phase 1 study in China to accelerate global clinical development of velinotamig in autoimmune diseases [3][4] Industry Context - T cell engagers are viewed as the next wave of innovation in autoimmune diseases, with BCMA as a promising target for a precise and potentially disease-modifying approach [3] - The collaboration with Genrix Bio is expected to enhance Cullinan's capabilities in developing therapies for autoimmune diseases, addressing the needs of a wider patient population [4][10]

Summary of Molecular Partners Conference Call Company Overview - **Company**: Molecular Partners - **Focus**: Development of DARPins, small binding proteins for targeted therapies in oncology [4][5] Key Platforms and Pipeline - **DARPins Platforms**: - **Radiotherapy DARPin Platform**: Utilizes small size to deliver radioisotopes effectively [6] - **T Cell Engager Platform**: Capable of creating bispecific to tetraspecific DARPins targeting multiple tumor antigens [6] - **Clinical Candidates**: - **MPO-712 (DLL3)**: Expected to enter Phase 1 trials in the second half of the year, targeting small cell lung cancer [12][15] - **MPO-533**: Involved in an ongoing Phase 1 trial for acute myeloid leukemia (AML) [44] DLL3 and Small Cell Lung Cancer - **Target**: DLL3, a marker for neuroendocrine tumors, particularly expressed in small cell lung cancer [15] - **Clinical Need**: High unmet medical need in small cell lung cancer, which is often chemo-resistant [15][13] - **Phase 1 Trial**: Aiming to start in the second half of the year, with a focus on relapsed refractory patients [16][19] Radioligand Therapy Insights - **Advantages of DARPins**: Selected for targets that are not easily ligandable, providing a solution for over 70% of targets [9][10] - **Imaging and Dosimetry**: Early imaging data expected to inform dosing and therapeutic windows, with results anticipated in H2 [19][20] - **Lead-212**: Chosen for its short half-life and effective energy delivery, partnered with OranoMed for supply [31][34] MPO-533 and AML Trial Adjustments - **Targeting Strategy**: Trispecific and tetraspecific DARPins designed to target multiple antigens on AML cells [46] - **Trial Adjustments**: Shifted to more frequent dosing to improve patient exposure and response rates, achieving a 30% complete response rate in recent evaluations [51][52] Future Developments - **Switched DARPin Platform**: Aiming to develop smart drugs that utilize logic gating to enhance T cell engagement [58][61] - **Investor Interest**: The new platform is generating interest from potential investors and pharmaceutical partners [62] Additional Considerations - **Supply Chain Management**: OranoMed's ability to provide a consistent supply of Lead-212 is crucial for the success of the radioligand therapy [39][41] - **Regulatory Engagement**: Ongoing constructive discussions with regulators to ensure effective clinical trial designs [29][42] This summary encapsulates the key points discussed during the conference call, highlighting Molecular Partners' innovative approaches in oncology and their strategic focus on DARPins and radioligand therapies.

Clinical programs on track, with two major milestones later this year, and cash position, CHF 131 million as of March 31, 2025, expected to provide funding well into 2027IND filing and initial clinical data on first targeted Radio-DARPin therapy program, MP0712, expected in 2025; strategic partnership with Orano Med expanded from four to ten programsData from dosing cohort 8 in Phase 1/2a trial of MP0533 demonstrate increased rates and depth of responses; study protocol amendment now approved, and dosing co ...

Merus (MRUS) 2025 Conference May 15, 2025 11:40 AM ET Speaker0 Good morning. Welcome to the final, day of the Bank of America Healthcare Conference. I'm Tazeen Ahmad. I'm one of the senior SMID biotech analysts at the firm. It's our pleasure to have with us, our next presenting company, Maris. Presenting from Maris this morning is CEO Bill Lindenberg. Bill, good morning. Thanks for flying to Las Vegas for us. Speaker1 Happy to be here. And let me also extend a great deal of thanks to you, to Zeen, and the e ...

Financial Data and Key Metrics Changes - The company reported a net loss of $22.6 million for Q1 2025, a decrease from a net loss of $31.7 million in Q1 2024, primarily due to increased revenue [11] - Revenue for Q1 2025 was $27.1 million, significantly up from $10 million in Q1 2024, driven by milestone revenues and development support [11][12] - Operating expenses increased to $52.7 million in Q1 2025 from $47.3 million in Q1 2024, reflecting a 10% rise [12][13] Business Line Data and Key Metrics Changes - Milestone revenue included $14 million from GSK and $3.1 million from Daiichi Sankyo, contributing to the overall revenue growth [11] - Research and development expenses rose to $35.7 million in Q1 2025 from $32 million in Q1 2024, mainly due to increased costs associated with ZW251 and other preclinical research [12] Market Data and Key Metrics Changes - The company anticipates increased royalty revenue from the potential approval of zanadatumab for advanced HER2 positive biliary tract cancer, with a final decision expected soon [10] - The company is also looking forward to presenting data at several upcoming medical conferences, which may enhance its market presence [9] Company Strategy and Development Direction - The company emphasizes a disciplined approach to cash burn and pipeline management, focusing on evidence-based decisions tied to clinical validation [8] - The R&D strategy includes advancing a diverse pipeline of ADCs and T cell engagers, with a focus on unmet needs in oncology and immunology [36][40] - The company plans to submit an IND for ZW251 by mid-2025, marking a significant milestone in its development strategy [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the dynamic biotech environment while delivering shareholder value [7][8] - The company remains well-capitalized with $321.6 million in cash and equivalents, projected to fund operations into the second half of 2027 [14][38] - Management highlighted the importance of clinical progress and disciplined capital allocation in creating long-term shareholder value [40] Other Important Information - The company presented six posters at the AACR annual meeting, showcasing advancements in its R&D pipeline [16][35] - The recent appointment of Dr. Sabine McCann as Senior VP of Clinical Development is expected to enhance the company's clinical strategy [37] Q&A Session Summary Question: What are the base case assumptions regarding milestone royalty revenues? - Management emphasized the importance of capital allocation and expressed excitement about the progress made by partners Jazz and Beijing, which could impact future revenues [44][46] Question: Can you provide details on the cytokine induction data for ZW209? - The design of ZW209 allows for localized T cell activation, which may limit cytokine release syndrome, presenting a favorable safety profile compared to other approaches [50][52] Question: How do you view the impact of ex-US patients in the Horizon GEA trial? - Management noted that there is generally no significant difference in efficacy across ethnicities, but they are monitoring the data closely [58][60] Question: What is the expectation for the KLK2 bispecific update at ASCO? - Management indicated that they are looking forward to the data presentation and highlighted the financial interest in the partnership with J&J [63][64] Question: How many internal programs can the company support? - The company can handle approximately five internal programs through phase one and about ten preclinical programs at any one time [87]

Financial Data and Key Metrics Changes - R&D expenses for Q1 2025 were $118.6 million, up from $100.1 million in Q1 2024, primarily due to a $30 million payment to Alnylam and expenses related to the ECLIPSE program initiation [36] - SG&A expenses for Q1 2025 were CAD 23.9 million, down from CAD 36.3 million in Q1 2024, largely due to cost savings from headcount reductions [37] - Net loss for Q1 2025 was $121 million compared to a net loss of $65.3 million in Q1 2024, driven by a significant drop in revenue from $52 million to approximately $3 million [38] Business Line Data and Key Metrics Changes - The hepatitis delta program has initiated the ECLIPSE Phase III program, with the first patient enrolled, marking a significant milestone [22] - The oncology portfolio continues to progress, with promising data from the Pro X10 dual masked T cell engager programs, particularly in HER2 positive colorectal cancer [15][28] Market Data and Key Metrics Changes - The estimated addressable market for hepatitis delta includes approximately 61,000 RNA positive patients in the U.S. and 113,000 in EU member countries plus the UK, highlighting the potential for significant commercial opportunity [10] - The company emphasizes that hepatitis delta has characteristics of a rare disease market with severe outcomes, supporting a value-based pricing model [11] Company Strategy and Development Direction - The strategic focus remains on advancing both infectious disease and oncology programs, with a commitment to developing a new standard of care for hepatitis delta virus infection [8] - The company is exploring collaborations to maximize value from the Pro X10 platform and has advanced a broadly neutralizing antibody in its HIV cure program [19] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenging market environment for the biotechnology sector but emphasizes a disciplined approach to capital allocation and operational excellence [20] - The company maintains a strong cash position of approximately $1 billion, providing a runway extending into mid-2027 to advance key programs [39] Other Important Information - The agreement with Alnylam regarding the profit-sharing arrangement has been clarified, with the company recognizing CAD 30 million as R&D expense in Q1 2025 [39] - The company is preparing for the upcoming EASL Congress to present data from its hepatitis B program and the Solstice trial [26] Q&A Session Summary Question: Alnylam decision and future oncology updates - Alnylam opted out of the profit-sharing arrangement based on their strategic portfolio prioritization, prior to the latest HCV functional cure data being available [47] - Future oncology data updates will include mature data at higher dose levels and comparative data between dosing regimens, expected to be shared at medical congresses or focused investor events [46] Question: ECLIPSE study enrollment and timelines - The ECLIPSE one study aims to complete enrollment by the end of 2025, with ECLIPSE two having a 24-week endpoint [55] Question: Competitive positioning of T cell engagers - The company believes its dual mask technology offers a favorable safety profile and differentiates it from competitors, with a focus on convenience and quality of life for patients [60][62] Question: Functional cure rates and HBV program development - The company anticipates presenting data showing a 20% functional cure rate in the doublet and a 30% in the triplet at the upcoming EASL [77] - Further development of the HBV program is contingent on securing a global development and commercialization partner [78] Question: Changes in U.S. guidelines for HBV diagnosis - No changes have been made to U.S. guidelines for delta diagnosis, but there is hope for increased awareness and reflex testing in the future [101]