Sunshine Guojian Pharmaceutical(688336)

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业绩符合预期,自免炎症产品稳步推进
Guolian Securities· 2024-04-09 16:00
证券研究报告 31.32 股价相对走势 -30% 7% 43% 80% 2023/3 2023/7 2023/11 2024/3 三生国健 沪深300 事件: 公司多个自免和炎症产品稳步推进。IL-17A 单抗于 2023Q4 在中重度斑块 状银屑病的 III 期临床中达到主要终点,公司预计于 2024 年完成该适应症 的 NDA 申请;IL-4Rα单抗在 2023Q3 在中重度特应性皮炎的 II 期临床研究 达到主要终点,Q4 启动 COPD 的 II 期临床,公司预计 2024 年该产品完成 皮炎的 III 期临床患者入组;IL-5 单抗 2024 年启动哮喘的 III 期临床入 组;IL-1β单抗计划 2024 年完成急性痛风性关节炎患者的 III 期临床患者 入组。 公 司 报 告│ 公 司 年 报 点 评 2 请务必阅读报告末页的重要声明 除非另有规定,本报告中的所有材料版权均属国联证券股份有限公司(已获中国证监会许可的证券投资咨询业务资格)及其附属机构(以下统称"国联证券")。 未经国联证券事先书面授权,不得以任何方式修改、发送或者复制本报告及其所包含的材料、内容。所有本报告中使用的商标、服务标识 ...
三生国健:华泰联合证券有限责任公司关于三生国健药业(上海)股份有限公司2023年年度持续督导跟踪报告
2024-04-03 08:22
无。 二、重大风险事项 公司目前面临的风险因素主要如下: 华泰联合证券有限责任公司 关于三生国健药业(上海)股份有限公司 2023年年度持续督导跟踪报告 根据《证券法》、《证券发行上市保荐业务管理办法》和《上海证券交易所科 创板股票上市规则》等有关法律、法规的规定,华泰联合证券有限责任公司(以 下简称"华泰联合证券"或"保荐机构")作为三生国健药业(上海)股份有限 公司(以下简称"三生国健"、"公司"或"发行人")持续督导的保荐机构,负 责三生国健上市后的持续督导工作,并出具本年度持续督导跟踪报告。 一、保荐机构和保荐代表人发现的问题及整改情况 杂环节,每一环节都有可能面临失败风险。未来,公司需持续进行创新药研发, 以保证公司不断有新产品推向临床进而推向市场。但公司无法保证可以持续地找 到有商业价值的适应症,公司筛选出的潜在产品有可能因为有效性不足等原因而 没有进一步开发的潜力。若公司无法持续的研发有商业潜力的新产品,可能会对 公司业务带来不利影响。 鉴于公司研发项目进程不断深化及对未来抗体药物研发领域的前瞻性布局, 研发项目前期投入增大,在研项目随其研发阶段所需而研发投入增多,预计公司 未来将继续产生较大量 ...
三生国健:华泰联合证券有限责任公司关于三生国健药业(上海)股份有限公司2023年度持续督导现场检查报告
2024-04-03 08:20
华泰联合证券有限责任公司 关于三生国健药业(上海)股份有限公司 2023年度持续督导现场检查报告 上海证券交易所: 经中国证券监督管理委员会《关于同意三生国健药业(上海)股份有限公司 首次公开发行股票注册的批复》(证监许可[2020]1217 号)批复,三生国健药业 (上海)股份有限公司(以下简称"三生国健"、"上市公司"、"公司")首次公开 发行人民币普通股(A 股)股票 6,162.11 万股,每股面值人民币 1 元,每股发行 价格人民币 28.18 元,募集资金总额为人民币 1,736,483,781.56 元,扣除承销费 以及其他发行费用(含增值税)后,实际募集资金净额合计人民币 1,634,428,187.64 元。本次发行证券已于 2020 年 7 月 22 日在上海证券交易所上 市。华泰联合证券有限责任公司(以下简称"华泰联合"、"保荐机构")担任其 持续督导保荐机构,持续督导期间为 2020 年 7 月 22 日至 2023 年 12 月 31 日。 根据《证券发行上市保荐业务管理办法》《上海证券交易所科创板股票上市 规则》《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》等 ...
三生国健:华泰联合证券有限责任公司关于三生国健药业(上海)股份有限公司保荐总结报告书
2024-04-03 08:20
保荐总结报告书 华泰联合证券有限责任公司 关于三生国健药业(上海)股份有限公司 首次公开发行股票并在科创板上市 之保荐总结报告书 保荐机构名称 华泰联合证券有限责任公司 保荐机构编号 Z26774000 一、保荐机构及保荐代表人承诺 1、保荐总结报告书和证明文件及其相关资料的内容不存在虚假记载、误导 性陈述或重大遗漏,保荐机构及保荐代表人对其真实性、准确性、完整性承担法 律责任。 2、本机构及本人自愿接受中国证券监督管理委员会(以下简称"中国证监 会")、上海证券交易所对保荐总结报告书相关事项进行的任何质询和调查。 3、本机构及本人自愿接受中国证监会按照《证券发行上市保荐业务管理办 法》的有关规定采取的监管措施。 二、保荐机构基本情况 | 情况 | 内容 | | --- | --- | | 保荐机构名称 | 华泰联合证券有限责任公司 | | 注册地址 | 深圳市前海深港合作区南山街道桂湾五路 128 号前海深港基金 | | | 小镇 B7 栋 401 | | 主要办公地址 | 深圳市福田区莲花街道益田路 5999 号基金大厦 27 层 | | 法定代表人 | 江禹 | | 联系人 | 徐妍薇、肖斯峻 | | ...
三生国健:关于召开2023年度业绩暨现金分红说明会的公告
2024-03-25 11:02
证券代码:688336 证券简称:三生国健 公告编号:2024-012 三生国健药业(上海)股份有限公司 关于召开 2023 年度业绩暨现金分红说明会的公告 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: 三生国健药业(上海)股份有限公司(以下简称"公司")已于 2024 年 3 月 21 日发布公司 2023 年年度报告,为便于广大投资者更 全面深入地了解公司 2023 年度经营成果、财务状况及利润分配情况, 公司计划于 2024 年 04 月 03 日上午 10:00-11:30 举行 2023 年度业绩 暨现金分红说明会,就投资者关心的问题进行交流。 一、 说明会类型 会议召开时间:2024 年 04 月 03 日(星期三) 上午 10:00-11:30 会 议 召 开 地 点 : 上 海 证 券 交 易 所 上 证 路 演 中 心 ( 网 址 : https://roadshow.sseinfo.com/) 会议召开方式:上证路演中心视频直播和网络互动 投资者可于 2024 年 03 月 27 日( ...
三生国健(688336) - 投资者关系活动记录表(2024年3月21-22日)
2024-03-25 07:34
三生国健药业(上海)股份有限公司 投资者关系活动记录表 三生国健药业(上海)股份有限公司 投资者关系活动记录表 一、 调研情况 调研时间:2023 年 3月 21-22 日 调研形式:三生国健 2023 年度业绩交流会 公司接待人员:董事长、总经理兼董秘、临床开发副总裁、研发副总裁、独立 董事、财务总监 参加机构:华泰证券、兴业证券、国联证券、华创证券、国泰君安证券、中泰 证券、东方证券、德邦证券、民生证券、中信证券、东吴证券、国信证券、天 风证券、国金证券、中金公司、开源证券、广发证券、平安证券、广发基金、 嘉实基金、招商基金、易方达基金、汇丰晋信基金、浙商基金、华安基金、福 安达基金、平安基金、银华基金、新华基金、大成基金、浦银安盛基金、汇添 富基金、东方红等近 180 家机构与个人。 二、调研主要内容 1、公司管理团队全面介绍公司 2023 年度业绩情况及各项业务进展(会议 PPT 详 见公司官网 https://www.3s-guojian.com/investor/) ...
2023年报业绩点评:业绩大幅提升,IL-17年底提交上市申请
Guotai Junan Securities· 2024-03-24 16:00
Investment Rating - The report maintains a "Buy" rating for the company, with a target price of 30.96, unchanged from the previous rating [2][3]. Core Insights - The company has significantly improved its performance, achieving a revenue of 1.014 billion with a year-on-year growth of 22.8%. The net profit attributable to the parent company reached 295 million, marking a substantial increase of 497.6% [2][3]. - The growth is primarily driven by the core product Yisai Pu's increased market penetration, rapid volume growth of Saipin and Jian Nipai, and recognition of certain income from the oncology pipeline collaboration with Shenyang Sanofi [2][3]. - The company is expected to submit NDA applications for its core pipeline products in the next four years, which is anticipated to further enhance performance growth [2][3]. Financial Summary - The company reported a total revenue of 1.014 billion in 2023, with a projected increase to 1.193 billion in 2024, reflecting an 18% growth [6]. - The net profit for 2023 was 295 million, with expectations of 301 million in 2024, indicating a 2% growth [6]. - The gross profit margin improved, and the company has capitalized on R&D investments while reducing expenses, contributing to the overall profitability [2][3]. Pipeline Development - The company has a robust pipeline with four core products expected to submit NDA applications from 2024 to 2027, including 608, 611, and 613, which are anticipated to enter Phase III clinical trials [2][3]. - The commercial team has a solid foundation in the immunology field, and there are expectations for the commercialization of core products [2][3]. Market Position - The company is recognized as a leader in the antibody drug sector in China, with a strong focus on innovative biopharmaceuticals and a well-established production base [2][3]. - The company has developed a significant market presence with three therapeutic antibody products already launched [2][3].
三生国健:审计委员会2023年度履职情况报告
2024-03-21 08:34
三牛国健药业(上海)股份有限公司 审计委员会 2023 年度履职情况报告 根据中国证监会《上市公司治理准则》、《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》等法 律法规、规范性文件,以及《公司章程》和《公司董事会审计委员会工作制度》的 有关规定,2023年度,三生国健药业(上海)股份有限公司(以下简称"公司")审 计委员会本着勤勉尽职的原则,积极开展各项工作,认真履行相关职责,现将审计 委员会 2023 年度的履职情况报告如下: 一、审计委员会基本情况 报告期内,审计委员会成员无变化,分别为独立董事金永利先生、独立董事黄 反之先生及非独立董事苏冬梅女士。以上委员任期均与公司本届董事会其他董事相 同,其中主任委员由金永利先生担任。 二、董事会审计委员会会议召开情况 2023年度,公司董事会审计委员会根据《公司法》、《公司章程》、《公司董 事会审计委员会工作制度》等相关规定,积极履行专业委员会职责。报告期内,公 司董事会审计委员会共召开了 5 次会议,全体委员都出席了会议,具体情况如下: | 会议名称 | 召开时间 | 会议议案 | | --- | ...
三生国健(688336) - 2023 Q4 - 年度财报
2024-03-20 16:00
Revenue and Financial Performance - The company's revenue from autoimmune diseases reached CNY 57,193.24 million, with a year-on-year increase of 7.73%[3] - Revenue from oncology products was CNY 22,598.50 million, showing a significant year-on-year growth of 41.8%[3] - The revenue from anti-rejection products amounted to CNY 4,365.08 million, reflecting a substantial year-on-year increase of 59.38%[3] - The company reported a total revenue of 1,060.10 million yuan for the year 2023[40] - The company reported a significant increase in revenue, achieving a total of 1.5 billion RMB, representing a 20% year-over-year growth[46] - The company achieved operating revenue of 1,014.03 million RMB in 2023, representing a year-on-year increase of 22.84%[186] - The company’s operating revenue for 2023 reached CNY 101,403.43 million, an increase of 22.84% compared to CNY 82,549.18 million in 2022[87] - The net profit attributable to shareholders was CNY 29,461.44 million, a significant increase of 497.63% from CNY 4,929.73 million in the previous year[87] - The company reported a net profit attributable to the parent company of 29,461.44 million yuan, a staggering increase of 497.63% compared to the previous year[94] - The company’s cash flow from operating activities improved due to increased sales and reduced operational expenses, while cash flow from financing activities showed a net repayment of short-term loans amounting to 100 million RMB[191] Research and Development (R&D) - The company has several key R&D projects in clinical phases, including a humanized monoclonal antibody for moderate to severe plaque psoriasis, currently in Phase III[6] - The company received approval for the NDA of a recombinant human TNF receptor-antibody fusion protein injection for rheumatoid arthritis and other conditions[6] - The company is advancing multiple projects in clinical trials, including a humanized monoclonal antibody for chronic obstructive pulmonary disease (COPD) which has received FDA clinical approval[6] - The company has a robust pipeline with several products in various stages of clinical trials, indicating a strong focus on innovation and market expansion[6] - The company categorizes R&D expenditures into research and development phases, with specific criteria for capitalization of development costs[8] - The company's R&D investment amounted to 49,772.59 million RMB, representing 30.98% of its operating revenue[10] - The average R&D investment among comparable companies in the same industry is 60,573.30 million RMB[10] - The company has a significant focus on R&D, with a net asset ratio of 6.44% for R&D investment[10] - The company reported a significant increase in R&D investment for project 608, which is currently in Phase III clinical trials[12] - The company has 14 ongoing autoimmune projects, with 4 in Phase III, 6 in Phase II, and 2 in Phase I clinical trials as of the report date[109] - The company has multiple innovative research technology platforms for antibody drug development, focusing on oncology and autoimmune diseases[150] - The company has established a comprehensive antibody drug platform covering discovery, development, registration, clinical trials, production, and commercialization, supported by over 20 years of continuous R&D[161] Market Strategy and Expansion - The major sales model, specialized academic promotion, generated 83,491.00 million RMB, a 19.56% increase compared to the previous year[13] - The company plans to strengthen its core competitiveness in the autoimmune disease sector following the licensing agreements with Shenyang Sansheng[19] - The company aims to expand its CDMO services in 2024, leveraging its production experience to provide high-quality, personalized services to emerging biopharmaceutical companies[25] - The company is focusing on the development of bispecific antibodies, which are expected to become a major trend in the antibody field, enhancing treatment efficacy by targeting multiple signaling pathways[23] - The company is enhancing its marketing strategy by leveraging digital platforms and strengthening its sales team to increase market coverage and product competitiveness[26] - The company is focused on becoming a leader in the autoimmune disease sector by building a differentiated capability through a well-structured R&D pipeline and a mature commercialization system[24] - The company is expanding its market presence in Southeast Asia, targeting a 10% market share by the end of 2024[46] - The company is actively developing new products, with three investigational new drug applications (INDs) submitted in the past year, targeting autoimmune diseases[80] - The company is focusing on developing new indications for existing products and exploring innovative targets and molecules to enhance its competitive edge in the autoimmune sector[96] Corporate Governance and Compliance - The company strictly adheres to corporate governance regulations, ensuring compliance with laws and enhancing operational standards[29] - The board of directors actively participates in meetings and has established four specialized committees to support decision-making[29] - The company maintains a robust information disclosure system, ensuring timely and accurate communication with shareholders[29] - There are no significant differences between the company's governance practices and regulatory requirements[30] - The company has not encountered issues regarding independence from its controlling shareholder[30] - The company has implemented measures to ensure compliance with legal and regulatory standards in its operations[29] - The company has received a standard unqualified audit report from Ernst & Young Hua Ming[63] - The board of directors has confirmed the authenticity and completeness of the annual report, ensuring no significant omissions or misleading statements[61] Challenges and Risks - The company acknowledges significant risks in innovative drug development, including long R&D cycles, high investment, and low success rates, which could adversely affect future product launches and market competitiveness[62] - Increased R&D expenditures are anticipated as the company deepens its project pipeline, which may lead to losses if R&D costs exceed profits from commercialized products[62] - The company faces risks related to market competition for its pipeline products, which may impact growth and profitability if not effectively managed[62] - The company anticipates challenges in 2024 due to significant price reductions from participation in the Guangdong Alliance procurement, which may impact Yisaipu's sales revenue[96] - The company faces risks from intensified market competition and potential price reductions due to centralized procurement policies[178] - The company recognizes the risks associated with innovation drug development and is establishing effective management and decision-making systems to mitigate these risks[176] Product Development and Innovation - The company is committed to building a competitive pipeline in the autoimmune disease sector through innovative new targets and expanding existing product indications[25] - The company is focused on strategic development and operational management under the leadership of Lou Jing since 2012[39] - The company is committed to continuous product development and innovation, laying a foundation for future product launches[135] - The company is exploring new targets in biological research and drug development to mitigate technology iteration risks[181] - The company is closely monitoring changes in pharmaceutical policies to adapt its business strategies accordingly[182] Financial Management and Investment - The company’s investment in bank wealth management products reached 60,387.04 million RMB at the end of the period[17] - The company plans to distribute a cash dividend of RMB 0.50 per 10 shares, totaling approximately RMB 30.84 million, which represents 10.47% of the net profit attributable to ordinary shareholders[64] - The total share capital as of December 31, 2023, is 616,785,793 shares, which will be used to calculate the dividend distribution[64] - The company has a commitment to maintaining transparency and accountability in its financial reporting and governance practices[40] - The company has a professional management team with an average of over 20 years of experience in the pharmaceutical industry, enhancing its strategic planning and operational management[165] Partnerships and Collaborations - The company has established partnerships with two major healthcare providers to enhance distribution channels[46] - The company has established partnerships with three leading research institutions to accelerate the development of new therapies[80] - The company generated revenue of 97.4 million from the exclusive licensing agreement with Shenyang Sansheng for its oncology projects in 2023[102] - The company has entered into exclusive licensing agreements for several oncology projects, enhancing its focus on autoimmune disease and inflammation drug development[19] Market Trends and Projections - The global autoimmune market is projected to grow from $132.3 billion in 2022 to $147.3 billion by 2025, with a CAGR of 3.6%, and is expected to reach $176.7 billion by 2030, with biologics accounting for 82.1% of the market share[137] - The Chinese autoimmune and inflammation market is expected to reach $6.1 billion by 2025, with a CAGR of 27.4% from 2022 to 2025, and is projected to exceed $19.9 billion by 2030[140] - The market share of biologics in China is anticipated to increase from 41.9% in 2022 to 69.3% by 2030, with the market size growing from $1.2 billion to $13.8 billion during the same period, reflecting a CAGR of 38.9%[140] - The increasing prevalence of autoimmune diseases and advancements in diagnostic technologies are expected to lead to higher diagnosis rates and treatment demand[137] - The biopharmaceutical industry is characterized by high investment, high technology, and high risk, requiring significant funding and talent for drug development, particularly in the complex field of biologics[143]
三生国健:安永华明会计师事务所(特殊普通合伙)关于三生国健非经营性资金占用及其他关联资金往来情况汇总表的专项审计报告
2024-03-20 11:32
关于三生国健药业(上海)股份有限公司 非经营性资金占用及其他关联资金往来情况 汇总表的专项审计报告 目 录 我们审计了三生国健药业(上海)股份有限公司的财务报表,包括2023年12月31 日的合并及公司资产负债表,2023年度的合并及公司利润表、股东权益变动表和现金 流量表以及相关财务报表附注,并于2024年3月20日出具了编号为安永华明(2024)审 字第70072706_B01的无保留意见审计报告。 按照《上市公司监管指引第8号——上市公司资金往来、对外担保的监管要求》的 要求,三生国健药业(上海)股份有限公司编制了后附的2023年度非经营性资金占用 及其他关联资金往来情况汇总表(以下简称"汇总表")。 如实编制和对外披露汇总表,并确保其真实性、合法性、完整性是三生国健药业 (上海)股份有限公司的责任。我们对汇总表所载资料与我们审计三生国健药业(上 海)股份有限公司2023年度财务报表时所复核的会计资料和经审计的财务报表的相关 内容进行了核对,在所有重大方面没有发现不一致之处。除了对三生国健药业(上海) 股份有限公司2023年度财务报表出具审计报告而执行的审计程序外,我们并未对汇总 表所载资料执行额外的审 ...