1月7日，亚盛医药-B(06855)宣布，公司原创新一代BTK靶向蛋白降解剂APG-3288的新药临床申请(IND)已获美国FDA许可，将开展其治疗复发/难治B细胞恶 性肿瘤的临床研究。这标志着公司在靶向蛋白降解领域的研发成果正式进入临床阶段，是亚盛医药全球创新管线的又一重大布局。 得益于这一消息利好，亚盛医药当日股价出现明显涨势：开盘后便一路走高，当日最大涨幅接近10%，二级市场的积极反馈显示出投资者对于公司在研创新 管线及内在价值的充分认可。 智通财经APP了解到，亚盛医药此次披露的这项研究是一项全球多中心、开放性的I期临床研究，旨在评估APG-3288治疗复发/难治性血液系统恶性肿瘤患者 的安全性、耐受性、PK特征及初步疗效。 通常来说，BTK是B细胞受体(BCR)信号通路中的关键激酶，在B细胞的活化、增殖和存活中发挥核心作用。BTK异常激活被认为与多种B细胞恶性肿瘤的发 生和进展密切相关，包括多种B细胞淋巴瘤(弥漫大B细胞淋巴瘤、套细胞淋巴瘤、滤泡性淋巴瘤等)、慢性淋巴细胞白血病(CLL)、以及华氏巨球蛋白血症 (WM)等。除肿瘤适应症外，BTK在B细胞受体(BCR)信号转导及先天免疫细胞Fc受体信号 ...

智通财经APP获悉，亚盛医药-B(06855)涨近4%，截至发稿，涨3.69%，报53.4港元，成交额6164.18万港 元。 消息面上，1月7日，亚盛医药官微消息，公司宣布，原创新一代BTK靶向蛋白降解剂 APG-3288的新药 临床申请(IND)已获美国FDA许可，将开展其治疗复发/难治B细胞恶性肿瘤的临床研究。这标志着公司 在靶向蛋白降解领域的研发成果正式进入临床阶段，是亚盛医药全球创新管线的又一重大布局。该研究 是一项全球多中心、开放性的I期临床研究，旨在评估APG-3288治疗复发/难治性血液系统恶性肿瘤患者 的安全性、耐受性、PK特征及初步疗效。 ...

消息面上，1月7日，亚盛医药官微消息，公司宣布，原创新一代BTK靶向蛋白降解剂APG-3288的新药 临床申请(IND)已获美国FDA许可，将开展其治疗复发/难治B细胞恶性肿瘤的临床研究。这标志着公司 在靶向蛋白降解领域的研发成果正式进入临床阶段，是亚盛医药全球创新管线的又一重大布局。该研究 是一项全球多中心、开放性的I期临床研究，旨在评估APG-3288治疗复发/难治性血液系统恶性肿瘤患者 的安全性、耐受性、PK特征及初步疗效。 亚盛医药-B(06855)涨近4%，截至发稿，涨3.69%，报53.4港元，成交额6164.18万港元。 ...

本资料难以设置访问权限，若给您造成不便，敬请谅解。感谢您的理解与配合。 摘要 差异化研发能力是公司的核心竞争力之一 。 差异化的高端仿制药选品与立项支撑起了公司早期成长 与资本原始积累，实现了在中小市值公司中的成功突围。站在当下时点，在即将到来的1-8批国采接续 落地后，我们判断，苑东的仿制药业务有望实现应采尽采，这一概念并不局限在存量品种的集采风险 出清，同时也包括了公司的光脚品种。一直以来苑东都非销售导向型公司，未来公司的增长仍需持续 且高效的研发转发，只不过这一转化要求是从集采仿制药转向非集采品种（如创新药、精麻药）。 根据《证券期货投资者适当性管理办法》及配套指引，本资料仅面向华创证券客户中的金融机构专业投资者，请勿对本资料进行任何形式的 转发。若您不是华创证券客户中的金融机构专业投资者，请勿订阅、接收或使用本资料中的信息。 免责声明 具体内容详见华创证券研究所2025年12月30日发布的报 告《 苑东生物（688513）深度研究报告系列二：体系整合，上海超阳打造差异化创 新竞争力》 法律声明 华创证券研究所定位为面向专业投资者的研究团队，本资料仅适用于经认可的专业投资者，仅供在新媒体背景下研究观点的 ...

Kymera Therapeutics (NasdaqGM:KYMR) FY Conference December 04, 2025 08:45 AM ET Company ParticipantsJared Gollob - CMOBruce Jacobs - CFOBruce JacobsAwesome.ModeratorAll right. We're going to go ahead and get started. So thanks so much for joining, everyone. Next up, we have Kymera Therapeutics. Really big year for you guys. Next year will be big, too. But maybe we can just start off with an overview of the company. So we have Bruce Jacobs, the CFO, Jared Gollob, who is the CMO. And over to you guys for an o ...

Kymera Therapeutics (NasdaqGM:KYMR) FY Conference December 02, 2025 02:30 PM ET Company ParticipantsNello Mainolfi - Founder, President, and CEOConference Call ParticipantsTed Tenthoff - Senior Biotechnology AnalystTed TenthoffGood evening, everyone. My name is Ted Tenthoff. I'm a senior biotech analyst at Piper Sandler, and before I begin, I'm required to point out certain disclosures regarding the relationship between Piper and our next presenting company, Kymera, which are posted both at the back of the ...

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $2.8 million, entirely from collaboration with Gilead [27] - R&D expenses for the quarter were $74.1 million, with adjusted cash R&D spend decreasing by 7% compared to the previous quarter [27][28] - G&A expenses were $17.3 million, with adjusted cash G&A spend down by 3% from the previous quarter [28] - The company ended September with a cash balance of $978.7 million, providing a runway into 2028 [28] Business Line Data and Key Metrics Changes - The STAT6 program has shown significant progress, with a Phase Ib trial in atopic dermatitis (AD) patients completed and data expected in December [6][7] - The company initiated a Phase IIb trial for AD and plans to start a Phase IIb asthma trial in 2026 [7][26] - The IRAF5 program has completed IND enabling studies and is on track for a Phase I trial in early 2026 [8][26] Market Data and Key Metrics Changes - The company is focusing on oral therapies for type two diseases, addressing a significant unmet need in the market [10][12] - The penetration of advanced therapies like injectable biologics in moderate to severe patients is less than 10%, indicating a substantial market opportunity [63] Company Strategy and Development Direction - The company aims to build a global biopharmaceutical company with a strong focus on oral immunology [6][10] - A strategic shift towards immunology has been made, leveraging the potential of protein degradation to create oral drugs with biologics-like activity [10][11] - The partnership with Gilead is expected to drive forward the CDK2 oncology molecular glue program [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of their pipeline and the potential for KT6:21 to provide a convenient oral treatment option for patients [18] - The company anticipates strong interest in their oral medicines, particularly in light of the limitations of current injectable therapies [22] - Management highlighted the importance of addressing the needs of patients who have limited access to advanced systemic therapies [63] Other Important Information - The company welcomed a new Chief Legal Officer, Brian Adams, who brings over two decades of experience in the life sciences sector [16] - The company is focused on maintaining high visibility within the medical and scientific communities through presentations and collaborations [7][8] Q&A Session Summary Question: Key characteristics that could enable KT6:21 to show differential efficacy versus dupilumab - Management highlighted that KT6:21 has demonstrated comparable activity to dupilumab in preclinical studies, with the potential for a similar or superior profile [35][36] Question: Expectations regarding the doses in the BROADEN study - The selected doses aim to understand the translation of healthy volunteer degradation profiles into patients, ensuring confidence in the Phase IIb dose selection [39][40] Question: Concerns about the baseline characteristics of enrolled patients - Management clarified that baseline TARC levels and EASI scores are critical factors, with expectations that the study population will reflect current trends in patient severity [44][48] Question: Powering considerations for the Phase IIb AD study - Management stated that the study is designed to be adequately powered to show the desired effect relative to placebo, with careful consideration of patient enrollment [54][56] Question: Plans for the asthma BRETH study - Management indicated that more details will be provided closer to the start of the study, with a focus on patient enrollment and endpoint considerations [70] Question: Competitive landscape for KT6:21 - Management emphasized the importance of being both first and best in the market, with confidence in the drug's efficacy and safety profile compared to competitors [92][94]

Core Viewpoint - The article emphasizes the significant advancements in cancer treatment, particularly through immunotherapy, which has made the five-year survival rate a more attainable goal for patients. The recognition of these advancements by the Nobel Prize highlights the importance of ongoing research in this field [1][2]. Group 1: Immunotherapy Breakthroughs - The CheckMate series of studies has laid the foundation for current immunotherapy practices, with the PD-1 inhibitor, Nivolumab, being a key development [2][4]. - The year 2025 marks the 43rd year of the company's presence in China and the fifth year of its "China 2030 Strategy," focusing on integrating global research with local patient needs [2][4]. Group 2: Focus on Gastrointestinal Tumors - Gastrointestinal tumors have a high incidence in China, and the company has made significant contributions to this area, particularly through the CheckMate-649 study, which has provided long-term survival benefits for advanced gastric cancer patients [5][6]. Group 3: Expanding Treatment Applications - The company has been proactive in exploring the role of immunotherapy in early-stage cancer, with Nivolumab receiving approvals for four early-stage indications in China, leading to improved treatment outcomes [7][8]. - The CheckMate-816 study has demonstrated the effectiveness of the "immunotherapy + chemotherapy" approach in early non-small cell lung cancer, changing clinical practices and offering hope for a cure [7][8]. Group 4: Long-term Evidence and Standards - The company emphasizes the importance of long-term follow-up studies, such as those from CheckMate-649 and CheckMate-816, which have confirmed significant survival benefits and established clinical standards [9][10]. Group 5: Accessibility Initiatives - The company has worked to enhance the accessibility of immunotherapy through collaborations with commercial insurance and patient assistance programs, benefiting over 40,000 patients [11][12]. - The introduction of a new commercial health insurance directory aims to include innovative drugs, further improving patient access to treatments [12][13]. Group 6: Future Directions - The company plans to continue its focus on immunotherapy while exploring new treatment combinations and expanding its pipeline with innovative therapies, including targeted protein degradation platforms [17][19]. - The integration of Chinese patient data into global research is expected to enhance the relevance of new therapies for local populations [21][22]. Group 7: Commitment Beyond Five Years - The company is committed to ongoing scientific innovation and addressing local needs as part of its "China 2030 Strategy," aiming to provide sustained contributions to cancer treatment and patient outcomes [23].

Core Viewpoint - Targeted protein degradation represents a significant advancement in treating diseases previously deemed untreatable, particularly for traditionally "undruggable" targets such as transcription factors and scaffold proteins [2][6]. Group 1: Development of New Screening Methods - A novel high-throughput screening platform named DEFUSE (DE ath FUS ion E scaper) has been developed to identify small molecule protein degraders, enabling efficient degradation of oncoprotein SKP2 [3][10]. - The DEFUSE platform utilizes a fusion of target proteins with a rapidly activated death protein, allowing for a visual representation of cell survival or death based on the presence of degradation compounds [6][8]. Group 2: Discovery of New Degraders - The research team identified a small molecule, SKPer1, which specifically promotes the degradation of the oncogenic protein SKP2 and selectively kills SKP2-expressing cancer cells [8][10]. - SKPer1 functions as a novel molecular glue degrader, recruiting SKP2 to the ubiquitin ligase STUB 1, facilitating its ubiquitination and subsequent degradation [8][10]. Group 3: Implications for Cancer Treatment - SKPer1 demonstrated significant tumor-suppressive effects in vivo and exhibited good safety profiles, indicating its potential as a therapeutic agent [10]. - The study suggests that a 10-amino acid sequence derived from SKP2 can serve as a universal degradation tag, allowing other target proteins fused with this tag to be recruited for degradation by SKPer1 [10].

Financial Data and Key Metrics Changes - The company is focused on delivering a new generation of medicines, particularly in immunology, with a significant unmet need in the market [5][6] - The company has shown that its drug KT621 can match the activity of established biologics like dupilumab in preclinical studies [8][9] Business Line Data and Key Metrics Changes - The primary focus has shifted to immunology, with all recent and ongoing programs targeting this area [5] - The STAT6 program is the most advanced, with two Phase 2b studies set to begin in Q4 of this year and Q1 of next year [7] Market Data and Key Metrics Changes - There are over 100 million patients in the seven major markets suffering from common immune inflammatory diseases, with only about 3% having access to advanced systemic therapies [5][6] Company Strategy and Development Direction - The company aims to create a paradigm shift in drug delivery with oral degraders that can provide the efficacy of biologics [6] - The strategy includes protecting the franchise through flawless execution and developing a second-generation molecule as an insurance policy [45][47] Management's Comments on Operating Environment and Future Outlook - Management believes they have the potential for a best-in-class Th2 drug and is optimistic about the upcoming Phase Ib study results [15][12] - The company acknowledges the competitive landscape but emphasizes its unique position and the effectiveness of its STAT6 program [44][48] Other Important Information - The company is also exploring additional programs beyond STAT6, including IRAK4 and potential treatments for autoimmune diseases [54][56] - The management is focused on ensuring the right patient population is enrolled in trials to achieve meaningful results [42][43] Q&A Session Summary Question: What should we expect from the Phase Ib data set in atopic dermatitis? - Management highlighted the importance of translating Phase I data into patients and confirming degradation effectiveness in active Th2 inflammation [12][13] Question: What was the driver for adding a second dose to the Phase Ib study? - The decision was made to ensure robust data for Phase IIb dose selection, allowing for a more comprehensive understanding of patient responses [20][22] Question: Are there specific eligibility criteria for the Phase Ib patients? - Yes, the criteria align with those used in previous studies, ensuring that patients have moderate to severe atopic dermatitis [34][36] Question: How does the company view competitive intensity in the STAT6 space? - The company believes it has a strong position and is focused on executing its strategy while monitoring competitors [44][48] Question: What are the company's thoughts on the broader platform and future opportunities? - The company is exploring various avenues in targeted protein degradation and is committed to developing complementary programs [53][57]