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艾力斯(688578) - 上海艾力斯医药科技股份有限公司投资者关系活动记录表-2023年11月30日
2023-12-01 08:36
Group 1: Investor Relations Activities - The company held investor communication meetings on November 29 and 30, 2023, with a total of 13 participants from various financial institutions [2][4]. Group 2: Drug Development and Clinical Trials - Fumetinib shows potential for treating NSCLC with EGFR 20 insertion mutations, with preliminary results from the FAVOUR study indicating an overall response rate (ORR) of 78.6% for the initial treatment group [5]. - The safety profile of Fumetinib is favorable, with most treatment-related adverse events (TRAEs) being grade 1-2, and no patients discontinued treatment due to TRAEs in the initial treatment group [5]. - The company is advancing two registration clinical studies for Fumetinib targeting EGFR 20 insertion mutations, aiming to provide more treatment options for patients [6]. Group 3: International Collaboration and Milestones - The company has partnered with Arrivent to initiate a global Phase III clinical trial for Fumetinib targeting EGFR 20 insertion mutations, with the first patient enrolled overseas [6][7]. - In October 2023, Fumetinib received "Breakthrough Therapy Designation" from the FDA, recognizing its superior efficacy in early clinical studies compared to existing treatments [7]. Group 4: Financial Performance - In Q3 2023, the company reported total revenue of CNY 599 million, a year-on-year increase of 175.67%, and a net profit of CNY 202 million, up 643.57% [10]. - For the first three quarters of 2023, total revenue reached CNY 1.348 billion, reflecting a growth of 160.34%, with a net profit of CNY 410 million, a 661.00% increase [11]. Group 5: Future Pipeline and Strategy - The company emphasizes the development of innovative drugs, with a focus on oncology, including pipelines for KRAS G12D, fourth-generation EGFR-TKIs, and SOS1 inhibitors [12].
艾力斯:中信证券股份有限公司关于上海艾力斯医药科技股份有限公司首次公开发行部分限售股上市流通的核查意见
2023-11-23 09:14
二、本次上市流通的限售股形成后至今公司股本数量变化情况 本次上市流通的限售股属于首次公开发行的部分限售股,自本次上市流通的 限售股形成至今,公司未发生因利润分配、公积金转增等事项导致股本数量变化 的情况。 中信证券股份有限公司 关于上海艾力斯医药科技股份有限公司 首次公开发行部分限售股上市流通的核查意见 中信证券股份有限公司(以下简称"中信证券"、"保荐机构")为上海艾力斯 医药科技股份有限公司(以下简称"公司"、"艾力斯")首次公开发行股票并上市 的保荐机构。根据《中华人民共和国公司法》《中华人民共和国证券法》《证券 发行上市保荐业务管理办法》《上海证券交易所科创板上市公司自律监管指引第 1 号——规范运作》《上海证券交易所科创板股票上市规则》等有关规定,对公 司首次公开发行部分限售股上市流通的事项进行了核查,核查情况如下: 一、本次上市流通的限售股类型 中国证券监督管理委员会于 2020 年 10 月 12 日出具了《关于同意上海艾力 斯医药科技股份有限公司首次公开发行股票注册的批复》(证监许可[2020]2559 号),同意上海艾力斯医药科技股份有限公司(以下简称"公司"或"艾力斯") 首次公开发行股票 ...
艾力斯:上海艾力斯医药科技股份有限公司首次公开发行部分限售股上市流通公告
2023-11-23 09:14
证券代码:688578 证券简称:艾力斯 公告编号:2023-047 上海艾力斯医药科技股份有限公司 首次公开发行部分限售股上市流通公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈 述或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 本次股票上市类型为首发限售股份;股票认购方式为网下,上市股数为 243,225,002 股。 本次股票上市流通总数为 243,225,002 股。 本次股票上市流通日期为 2023 年 12 月 4 日。 一、本次上市流通的限售股类型 中国证券监督管理委员会于 2020 年 10 月 12 日出具了《关于同意上海艾力斯 医药科技股份有限公司首次公开发行股票注册的批复》(证监许可[2020]2559 号), 同意上海艾力斯医药科技股份有限公司(以下简称"公司"或"艾力斯")首次公 开发行股票的注册申请,公司向社会公开发行人民币普通股 90,000,000 股,并于 2020 年 12 月 2 日在上海证券交易所科创板上市交易。首次公开发行股票完成后, 公司总股本为 450,000,000 股,其中有限售条件流通股 381,54 ...
艾力斯(688578) - 上海艾力斯医药科技股份有限公司投资者关系活动记录表
2023-11-13 10:30
Group 1: Investor Relations Activity - The investor relations activity included a telephone conference on November 9, 2023, with 132 participants from various investment firms [2][5]. - The meeting lasted from 15:00 to 15:40, focusing on the company's collaboration with Basilea Pharmaceutica [5][6]. Group 2: Collaboration with Basilea - On November 8, 2023, the company signed a collaboration agreement with Basilea, acquiring exclusive commercialization rights for the RET inhibitor, Pujihua® (Pralsetinib) in mainland China [5][6]. - Pujihua® is the first approved RET inhibitor in mainland China, with indications for non-small cell lung cancer (NSCLC) and thyroid cancer [6][7]. Group 3: Market Potential and Product Features - RET fusion mutations account for approximately 1-2% of NSCLC patients, translating to about 10,000 to 20,000 new patients annually in China [10]. - The increasing prevalence of genetic testing is expected to enhance the detection rate of RET mutations, expanding the market for RET inhibitors [10]. Group 4: Future Development and Pipeline - The company is focused on developing innovative drugs, including a fourth-generation EGFR-TKI and a new generation EGFR-TKI targeting EGFR-C797S mutations, currently in preclinical development [11][12]. - The company aims to accelerate the development of its product pipeline, which includes KRAS G12D inhibitors and SOS1 inhibitors, to bring more innovative and high-quality drugs to market [12].
艾力斯:上海艾力斯医药科技股份有限公司关于召开2023年第三季度业绩说明会的公告
2023-11-13 08:16
二、业绩说明会召开的时间、地点和方式 证券代码:688578 证券简称:艾力斯 公告编号:2023-046 上海艾力斯医药科技股份有限公司 关于召开 2023 年第三季度业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: 上海艾力斯医药科技股份有限公司(以下简称"公司")已于 2023 年 10 月 26 日在上海证券交易所网站(www.sse.com.cn)披露 2023 年第三季度报告,为 加强与投资者的深入交流,在上海证券交易所的支持下,公司计划于 2023 年 11 月 27 日(星期一)下午 14:00-15:00 召开 2023 年第三季度业绩说明会,就投资 者关心的问题进行交流。 一、业绩说明会类型 本次业绩说明会以网络文字互动形式召开,公司将针对 2023 年第三季度的 经营成果及财务指标的具体情况与投资者进行互动交流和沟通,在信息披露允许 的范围内就投资者普遍关注的问题进行回答。 四、投资者参与方式 1、投资者可于 2023 年 11 月 27 日(星期一)下午 14:00- ...
艾力斯:上海艾力斯医药科技股份有限公司自愿披露关于甲磺酸伏美替尼片用于EGFR20号外显子插入突变NSCLC一线治疗获得FDA突破性疗法认定的公告
2023-10-30 11:01
证券代码:688578 证券简称:艾力斯 公告编号:2023-045 上海艾力斯医药科技股份有限公司 自愿披露关于甲磺酸伏美替尼片用于 EGFR 20 号外显子插 入突变 NSCLC 一线治疗获得 FDA 突破性疗法认定的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 一、相关情况概述 近日,上海艾力斯医药科技股份有限公司(以下简称"公司")的海外合作 伙伴 ArriVent Biopharma, Inc.(以下简称"ArriVent")获得美国食品药品监督管 理局(以下简称"FDA")授予甲磺酸伏美替尼片(商品名"艾弗沙®️",以下 简称"伏美替尼")用于治疗先前未接受过治疗、局部晚期或转移性非鳞状非小 细胞肺癌(NSCLC)且伴有表皮生长因子受体(EGFR)外显子 20 号插入突变患 者的突破性疗法认定(Breakthrough Therapy Designation)。这是继伏美替尼适用 于 EGFR 20 号外显子插入突变 NSCLC 二线治疗适应症于 2022 年 4 月获得中国 国家药品监督管理局药品审评 ...
艾力斯(688578) - 上海艾力斯医药科技股份有限公司投资者关系活动记录表-2023年10月26日
2023-10-30 08:50
证券代码:艾力斯 证券简称:688578 上海艾力斯医药科技股份有限公司投资者关系活动记录表 ( 2023 年 10 月) □特定对象调研 □分析师会议 □媒体采访 □业绩说明会 投资者关系活 □新闻发布会 □路演活动 动类别 □现场参观 √其他 投资者电话交流会 参与单位名称 2023年10月26日 10:00-11:00 及人员姓名 线上参会投资者:(共151位) AIHC 一位;CSFG 一位;Fountain 一位;HBM 一位; ...
艾力斯(688578) - 2023 Q3 - 季度财报
2023-10-25 16:00
Financial Performance - The company's revenue for Q3 2023 reached ¥599,127,050.54, representing a year-over-year increase of 175.67%[4] - Net profit attributable to shareholders for Q3 2023 was ¥202,012,904.91, a significant increase of 643.57% compared to the same period last year[4] - The net profit excluding non-recurring gains and losses for Q3 2023 was ¥196,178,109.98, reflecting a remarkable growth of 1,226.74% year-over-year[4] - The basic earnings per share for Q3 2023 was ¥0.45, up 643.57% year-over-year[4] - Total operating revenue for the first three quarters of 2023 reached ¥1,347,801,762.83, a significant increase from ¥517,717,492.02 in the same period of 2022, representing a growth of approximately 160%[16] - Net profit for the third quarter of 2023 was ¥410,427,066.86, compared to ¥53,932,347.03 in the same quarter of 2022, indicating a substantial increase of about 661%[17] - Basic and diluted earnings per share for the third quarter of 2023 were both ¥0.91, up from ¥0.12 in the same quarter of 2022, reflecting a growth of 658%[18] - Total comprehensive income for the third quarter of 2023 was ¥412,056,257.48, compared to ¥58,289,725.34 in the same quarter of 2022, indicating an increase of approximately 608%[17] Assets and Liabilities - The total assets at the end of Q3 2023 amounted to ¥3,974,952,121.41, which is a 15.48% increase from the end of the previous year[5] - As of September 30, 2023, the company's total assets amounted to RMB 3.975 billion, up from RMB 3.442 billion at the end of 2022[14] - Total liabilities and equity as of the end of the third quarter of 2023 were ¥3,974,952,121.41, compared to ¥3,442,172,227.84 in the same period of 2022, reflecting a growth of about 15.5%[17] Cash Flow - The company reported a net cash flow from operating activities of ¥461,873,407.41 for the year-to-date period, reflecting a 1,262.82% increase year-over-year[4] - Cash flow from operating activities for the first three quarters of 2023 was ¥461,873,407.41, a significant increase from ¥33,891,027.22 in the same period of 2022[19] - The net cash flow from investing activities for Q3 2023 was $208.71 million, compared to $344.52 million in Q3 2022, indicating a decrease of approximately 39.4%[20] - The net cash flow from financing activities was -$2.19 million, an improvement from -$4.79 million in the same quarter last year, reflecting a reduction in cash outflow by about 54.3%[20] - The net increase in cash and cash equivalents for Q3 2023 was $674.11 million, significantly higher than $389.14 million in Q3 2022, representing an increase of about 73.3%[20] - The ending balance of cash and cash equivalents was $988.98 million, slightly down from $1.00 billion at the end of Q3 2022[20] Research and Development - Research and development expenses for Q3 2023 totaled ¥78,181,189.54, an increase of 61.67% compared to the same period last year[4] - Research and development expenses for the first three quarters of 2023 totaled ¥191,351,163.78, compared to ¥137,289,093.00 in the same period of 2022, representing an increase of about 39.4%[16] - The proportion of R&D expenses to revenue decreased to 13.05%, down 9.2 percentage points from the previous year[4] - The company is conducting a Phase III clinical trial for the treatment of NSCLC with the drug Furmetinib, which has shown promising preliminary efficacy and safety results[12] - The company has been granted approval for multiple clinical studies, including a trial comparing Furmetinib with platinum-based chemotherapy for specific NSCLC mutations[12] Strategic Outlook - The company anticipates continued growth in sales volume due to the inclusion of its core product in the national medical insurance directory, contributing to revenue expansion[7] - The company aims to continue its strategic development and commercialize its products to achieve excellent operational performance for its investors[12] - The company is focused on enhancing corporate governance and improving overall management quality to strengthen its competitive advantage in core business areas[12] Inventory and Receivables - The company reported a significant increase in accounts receivable, rising to RMB 216.01 million from RMB 150.85 million year-over-year[14] - The company's inventory increased to RMB 60.19 million from RMB 32.07 million year-over-year, reflecting growth in product availability[14]
艾力斯(688578) - 上海艾力斯医药科技股份有限公司投资者关系活动记录表-2023年10月19日
2023-10-23 07:44
证券代码:艾力斯 证券简称:688578 上海艾力斯医药科技股份有限公司投资者关系活动记录表 ( 2023 年 10 月) □特定对象调研 □分析师会议 □媒体采访 □业绩说明会 投资者关系活 □新闻发布会 □路演活动 动类别 □现场参观 √其他 投资者交流会 参与单位名称 2023年10月18日 15:00-16:00 及人员姓名 参会投资者:(共2位) 海通证券 一位;南方东英 一位。 ...
艾力斯(688578) - 上海艾力斯医药科技股份有限公司投资者关系活动记录表-2023年10月12日
2023-10-13 10:10
Group 1: Company Overview - Ailis is an innovative pharmaceutical company focused on cancer treatment, particularly in the non-small cell lung cancer (NSCLC) sector, with a strong R&D pipeline [3] - The company aims to develop first-in-class and best-in-class drugs to meet unmet clinical needs globally [3] - Ailis reported a significant growth in business performance in the first three quarters of 2023, driven by the inclusion of its core product, Furmetinib, in the national medical insurance directory [4] Group 2: Financial Performance - In the first three quarters of 2023, Ailis expects to achieve a revenue of CNY 1.349 billion, an increase of CNY 0.831 billion, representing a year-on-year growth of 160.52% [4] - The projected net profit attributable to the parent company is CNY 0.397 billion, up CNY 0.343 billion, with a year-on-year increase of 636.61% [4] - The net profit excluding non-recurring gains is expected to be CNY 0.366 billion, an increase of CNY 0.347 billion, reflecting a growth of 1,796.78% year-on-year [4] Group 3: Product Development and Clinical Trials - Furmetinib has received IND approval for multiple clinical trials, including a Phase III trial for first-line treatment of EGFR 20 insertion mutation NSCLC [5][11] - The drug has shown promising results in clinical trials, with an objective response rate (ORR) of 78.6% for the initial treatment group at 240 mg [11] - Furmetinib's safety profile is favorable, with most treatment-related adverse events (TRAEs) being grade 1-2 [11][12] Group 4: Market Strategy and Expansion - Ailis has established a marketing team covering over 1,000 hospitals across 30 provinces, with commercial partners reaching over 2,000 hospitals [10] - The company is actively exploring partnerships to enhance its product pipeline, including collaborations for combination therapies with Furmetinib [16] - Ailis plans to maintain high R&D investment, with CNY 132 million allocated in the first half of 2023, focusing on expanding indications for Furmetinib and developing new drugs [12][13] Group 5: Future Outlook - The company anticipates continued growth in R&D investment in the coming years, particularly in addressing rare mutations and expanding treatment options for NSCLC [13][15] - Ailis is preparing for negotiations to renew medical insurance coverage for Furmetinib, which was first included in 2022 [13] - The company is committed to addressing unmet clinical needs in the lung cancer treatment space, particularly for patients with rare mutations [15]