关于与合作方签署司美格鲁肽注射液合作协议的公告 证券代码：300199 证券简称：翰宇药业 公告编号：2024-038 深圳翰宇药业股份有限公司 1、2024年5月27日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇 药业"）召开了第五届董事会第二十六次会议，审议通过了《关于与合作方签署司 美格鲁肽注射液合作协议的议案》，同意公司与浙江三生蔓迪药业有限公司（以下 简称"三生蔓迪"）签署《司美格鲁肽注射液合作协议》，本协议约定，公司将与 三生蔓迪共同合作开发、独家供应/采购、销售分成司美格鲁肽注射液（减重适应症）， 三生蔓迪将根据协议约定向翰宇药业支付：里程碑付款、独家采购价、以及约两位 数销售提成，其中里程碑付款主要由临床前技术成果对价款、委托开发和注册里程 碑付款、条件性付款以及销售里程碑付款四大部分组成。公司将合作产品的临床前 技术研究成果转让给三生蔓迪，并接受三生蔓迪的委托开展临床试验及注册申报工 作，以促使三生蔓迪作为司美格鲁肽注射液（减重适应症）在特定区域内的药品上 市许可持有人（"MAH"），授予其独家市场营销权，负责合作产品在区域内的商业 化；同时，三生蔓迪将委托公司负责司美格鲁肽注射液（ ...

证券代码：300199 证券简称：翰宇药业 公告编号：2024-036 深圳翰宇药业股份有限公司 关于醋酸加尼瑞克注射液获批上市的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 近日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"）收到 国家药品监督管理局下发的《药品注册证书》（受理号：CYHS2201612），公司"醋 酸加尼瑞克注射液"获得药品注册批准，具体内容如下： 一、批件基本信息 药品名称：醋酸加尼瑞克注射液 剂型：注射剂 适应症：醋酸加尼瑞克注射液在接受辅助生殖技术（ART）控制性卵巢刺激 （COS）方案的妇女中使用，用于预防过早出现促黄体激素（LH）峰。 规格：0.5ml:0.25mg（以 C₈₀H₁₁₃N₁₈O₁₃Cl 计） 包装规格：1 支/盒，5 支/盒，10 支/盒 注册分类：化学药品 4 类 批准文号：国药准字 H20243797 产品分类：化学药品 药品有效期：24 个月 上市许可持有人：深圳翰宇药业股份有限公司 药品生产企业：南京健友生化制药股份有限公司 审评结论：根据《中华人民共和国药品管理法》及有关规定，经审查， ...

本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 2024年5月20 日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰宇药业"） 召开第五届董事会第二十五次会议，审议通过了《关于公司拟与中关村科学城管理 委员会签署合作协议的议案》，公司与中关村科学城管理委员会签署了《支持深圳翰 宇药业股份有限公司驻区发展协议》，现将具体情况公告如下： 深圳翰宇药业股份有限公司 关于公司与中关村科学城管理委员会签署合作协议的公告 证券代码：300199 证券简称：翰宇药业 公告编号：2024-033 一、合作对手方介绍 单位名称：中关村科学城管理委员会 统一社会信用代码：111101080000579716 法定代表人：王合生 主要职责：根据市政府授权，组织编制中关村科学城各项规划，按程序报批后 组织实施；研究提出吸纳和集聚创新要素资源、打造创新创业集群的政策措施；负 责培育和发展科技创新企业，推动高端高新产业发展工作；推进园区管理和服务体 制机制创新，强化园区管理及服务功能，推进投融资、产权、中介等市场要素和体 系建设；协调推动重点工程、特色产业基地建设，服务重大项目落地。 ...

证券代码：300199 证券简称：翰宇药业 公告编号：2024-032 深圳翰宇药业股份有限公司 本次会议于 2024 年 5 月 20 日下午 15:30 在公司龙华总部 2006 董事会会议室以现 场结合通讯方式召开。会议应出席董事 9 人，实际出席会议董事 9 人，其中董事、执行 总裁 PINXIANG YU 女士、董事、副总裁唐洋明先生、独立董事钟廉先生、胡文言先生 以通讯表决方式出席会议。本次会议由董事长曾少贵先生召集和主持，公司监事及部分 高级管理人员列席了本次会议。 本次会议的召集、召开符合《中华人民共和国公司法》和《公司章程》的有关规定， 会议决议合法、有效。 二、董事会会议审议情况 （一）审议通过《关于公司拟与中关村科学城管理委员会签署合作协议的议案》 经审议，同意公司与中关村科学城管理委员会签署《支持深圳翰宇药业股份有限公 司驻区发展协议》，本次合作将为公司现有业务开展创造更大的竞争优势，提升公司的 综合实力，助力公司发展，有利于实现公司与合作方的优势互补及合作共赢，增强协同 效应。 具体内容详见公司同日刊登在中国证监会指定创业板信息披露网站巨潮资讯网的 相关公告。 第五届董事会第二十五次 ...

证券代码：300199 证券简称：翰宇药业 公告编号：2024-034 深圳翰宇药业股份有限公司 上述综合授信内容包括但不限于流动资金贷款、项目贷款、融资租赁、银行承 兑汇票、保函、保理、开立信用证、贸易融资、票据贴现等综合授信业务，上述授 信额度内的单笔融资不再上报董事会审议。 以上向银行申请综合授信额度事项授权公司董事长签署相关授信文件、授权经 营层根据资金需求情况在前述授信额度内使用。 关于向银行申请综合授信额度的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记 载、误导性陈述或重大遗漏。 深圳翰宇药业股份有限公司（以下简称"公司"）于 2024 年 5 月 20 日召开第五 届董事会第二十五次会议，审议通过了《关于向银行申请综合授信额度的议案》， 根据公司业务经营发展的需要，为进一步拓展融资渠道、优化财务结构、补充公司 流动资金，保证公司发展需求。同意公司向银行申请不超过 4 亿元综合授信额度， 现将具体情况公告如下： 1、同意公司向渤海银行深圳分行申请额度不超过 3 亿元人民币的综合授信额度， 授信期限暂定为 3 年，本次融资授信担保方式及授信额度与期限以银行实际审批为 准 ...

特此公告。 深圳翰宇药业股份有限公司董事会 2024 年 5 月 21 日 关于聘任公司高级管理人员的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记 载、误导性陈述或重大遗漏。 2024年5月20日，公司召开第五届董事会第二十五次会议，审议通过了《关于聘 任公司高级管理人员的议案》，根据公司发展和管理的需要，经公司董事长提名， 提名委员会对候选人的教育背景、任职经历、专业能力和职业素养予以审核，同意 聘请张宝乐先生为公司副总裁，分管海外营销（简历见附件），任期自本次董事会 审议通过之日起，至本届董事会任期届满之日止。 证券代码：300199 证券简称：翰宇药业 公告编号：2024-035 深圳翰宇药业股份有限公司 张宝乐简历如下： 截至本公告披露日，张宝乐先生未持有公司股份，与持有公司5%以上股份的其 他股东、实际控制人、公司董事、监事、高级管理人员之间不存在关联关系，不存 在《公司法》《公司章程》中规定的不得担任公司高级管理人员的情形，未受过中 国证监会及其他有关部门的处罚和证券交易所惩戒，不存在《深圳证券交易所上市 公司自律监管指引第2号—创业板上市公司规范运作》第3.2.3条 ...

法律意见书 国浩律师（深圳）事务所 关于 深圳翰宇药业股份有限公司 二〇二三年度股东大会 的 法律意见书 北京·上海·深圳·杭州·广州·昆明·天津·成都·宁波·福州·西安·南京·南宁·济南·重庆 Beijing·Shanghai·Shenzhen·Hangzhou·Guangzhou·Kunming·Tianjin·Chengdu ·Ningbo ·Fuzhou·Xi`an·Nanjing·Nanning·Jinan·Chongqing 苏州·长沙 ·太原·武汉·贵阳·乌鲁木齐·郑州·石家庄·合肥·海南·青岛·南昌·大连·银川·拉孜 Suzhou·Changsha·Taiyuan·Wuhan ·Guiyang·Wulumuqi·Zhengzhou·Shijiazhuang·Hefei·Hainan·Qingdao·Nanchang·Dalian·Yinchuan·Lhatse 香港·巴黎·马德里·硅谷·斯德哥尔摩 Hongkong·Paris·Madrid·Silicon Valley·Stockholm 深圳市深南大道 6008 号特区报业大厦 24、31、41、42 层 邮编：518034 24、31、4 ...

证券代码：300199 证券简称：翰宇药业 公告编号：2024-031 深圳翰宇药业股份有限公司 2023年年度股东大会决议公告 本公司及董事会全体成员保证信息披露内容的真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 特别提示： 1、本次股东大会没有否决或变更议案的情况发生。 2、本次股东大会不涉及变更前次股东大会决议。 一、会议召开和出席情况 1、2024年4月25日，深圳翰宇药业股份有限公司（以下简称"公司"或"翰 宇药业"）第五届董事会第二十四次会议审议通过《关于提请召开2023年年度股 东 大 会 的 议 案 》 ， 详 见 公 司 在 中 国 证 监 会 指 定 信 息 披 露 网 站 （http://www.cninfo.com.cn）披露的相关公告。 2023年年度股东大会召开的基本情况如下： 会议召集人：公司董事会 会议方式：本次会议采取现场投票和网络投票相结合的方式 会议地点：深圳市龙华区观澜高新园区观盛四路7号翰宇创新产业大楼会议 室 会议主持人：董事长曾少贵先生 本次会议的召集、召开符合《公司法》《上市公司股东大会规则》以及《公 司章程》《股东大会议事规则》等的有关规定，合法有 ...

国浩律师（深圳）事务所 关于 深圳翰宇药业股份有限公司 二〇二二年限制性股票激励计划 作废部分限制性股票相关事项 的 法律意见书 北京·上海·深圳·杭州·广州·昆明·天津·成都·宁波·福州·西安·南京·南宁·济南·重庆 Beijing·Shanghai·Shenzhen·Hangzhou·Guangzhou·Kunming·Tianjin·Chengdu ·Ningbo ·Fuzhou·Xi`an·Nanjing·Nanning·Jinan·Chongqing 苏州·长沙·太原·武汉·贵阳·乌鲁木齐·郑州·石家庄·合肥·海南·青岛·南昌·大连·银川·拉孜 Suzhou·Changsha·Taiyuan·Wuhan ·Guiyang·Wulumuqi·Zhengzhou·Shijiazhuang·Hefei·Hainan·Qingdao·Nanchang·Dalian·Yinchuan·Lhatse 香港·巴黎·马德里·硅谷·斯德哥尔摩 Hongkong·Paris·Madrid·Silicon Valley·Stockholm 深圳市深南大道 6008 号特区报业大厦 24、31、41、42 层 邮编：518 ...

Financial Performance - Net profit attributable to shareholders decreased by 38.68% year-on-year in 2023, primarily due to significant price reductions of key products entering centralized procurement and delayed international business contracts contributing minimally to 2023 profits[7] - Quarterly revenue declined from 176,222,802.86 in Q1 to 29,828,864.39 in Q4, with net profit turning from 18,605,574.69 in Q1 to -333,326,785.70 in Q4[13] - Revenue in 2023 decreased by 38.75% to 431,384,112.87 yuan compared to 704,321,731.88 yuan in 2022[65] - Net profit attributable to shareholders in 2023 was -513,876,149.69 yuan, a decrease of 38.68% from -370,550,318.41 yuan in 2022[65] - Operating cash flow in 2023 was -3,536,573.51 yuan, a decrease of 122.37% from 15,807,431.54 yuan in 2022[66] - Total assets at the end of 2023 decreased by 9.25% to 3,277,193,711.56 yuan from 3,611,233,247.62 yuan at the end of 2022[66] - Net assets attributable to shareholders at the end of 2023 decreased by 40.28% to 758,803,660.30 yuan from 1,270,636,709.44 yuan at the end of 2022[66] - The company's net profit attributable to shareholders for the year was -354,843,109.53 RMB, with a significant loss in the fourth quarter[59] - The company's recent three fiscal years have shown negative net profits after deducting non-recurring gains and losses, raising concerns about its ongoing operational capabilities[57] - The company's non-current asset disposal losses in 2023 amounted to -2,322,023.63 thousand yuan, compared to a gain of 2,913,871.36 thousand yuan in 2022 and 34,994,359.55 thousand yuan in 2021[90] - The company reported a net profit attributable to the parent company of -51,387.61 thousand yuan in 2023, accounting for 40.44% of the net assets at the end of the previous year[107] Product Development and R&D - The company is collaborating with the Chinese Academy of Sciences to develop a COVID-19 peptide nasal spray drug (HY3000)[31] - A partnership with the Chinese CDC aims to develop a peptide vaccine (HY3001) based on two patented technologies[31] - The company is working with Shenzhen Third People's Hospital to develop a COVID-19 antigen detection kit (HY3002)[31] - The company is involved in the development of new drugs, including Cabergoline and Atosiban, which are in various stages of clinical trials[49] - The company received approval for clinical trials of Semaglutide Injection from the National Medical Products Administration on December 4, 2023[69] - The company's Semaglutide Injection received clinical approval for diabetes treatment in December 2023[169] - The company's Vildagliptin Tablets, Octreotide Acetate Injection, and Terlipressin Injection were approved for market release in January 2023, with Terlipressin Injection indicated for esophageal variceal bleeding[161][162][163] - The company's injection of Cetrorelix Acetate was approved and passed consistency evaluation in July 2023[167] - Linaclotide capsule received clinical approval in May 2023[190] - Carbetocin injection was approved for new vaginal secretion indication in July 2023[192] - HY3000 nasal spray received clinical approval for treating mild to moderate COVID-19 in September 2023[193] - COVID-19 antigen test kit (latex method) was approved in September 2023[194] - Desmopressin acetate injection passed consistency evaluation in October 2023[195] - The company's HY3000 nasal spray, a novel peptide fusion inhibitor, demonstrated significant anti-COVID-19 effects in preclinical studies, showing strong inhibitory activity against multiple variants including Delta, Omicron BA.1, BA.2, and BA.4[167] - The company's R&D innovation focuses on weight loss, diabetes, and women's reproductive health products, as well as API export business[138] - The company's future development plans, product advantages, and R&D strengths were discussed with 25 investors[141] - The company's R&D investment, API business progress, and innovation drug development were discussed with institutional investors[141] - The company's international strategy and "weight loss drug" product layout were discussed with over 90 institutional investors[141] - The company's overseas business layout, current development status, and future plans were discussed with over 100 offline and 170,000 online investors[141] International Business and Strategy - International business contracts, mainly scheduled for 2024, contributed minimally to 2023 profits[7] - The company's overseas sales continued to grow in 2023, with the successful export of Liraglutide preparations and GLP-1 APIs, marking the initial success of its "Global Vision, Local Roots" international strategy[158] - The company's international strategy and "weight loss drug" product layout were discussed with over 90 institutional investors[141] - The company's overseas business layout, current development status, and future plans were discussed with over 100 offline and 170,000 online investors[141] Corporate Structure and Operations - The company's subsidiaries include Hong Kong HanYu, Wuhan HanYu, and Chengji Pharmaceutical, among others[27] - The company's operations span multiple locations, including Longhua headquarters, Pingshan branch, and Nanshan branch[27] - The company's stock code is 300199, and it is listed on the Shenzhen Stock Exchange[52] - The company's registered and office address is located in the Longhua District, Shenzhen, China[52] - The company's annual report is disclosed on major financial media platforms such as the Securities Times and the China Securities Journal[54] - The company's website is http://www.hybio.com.cn, and its email is hy@hybio.com.cn[52] - The company's legal representative is Zeng Shaogui[52] - The company's controlling shareholder and actual controller did not change during the reporting period[79][81] - The company's production model is based on "sales-driven production + small inventory" to ensure timely delivery[150] - The company's sales model includes direct sales and intermediary trade for APIs, and distribution and licensing for formulations[151] - The company has a leading position in peptide drug production and development, with a complete and efficient industrialization system[154] - The company has advanced R&D facilities, including over 300 specialized equipment from the US, Germany, and Switzerland[155] - The company has established a comprehensive quality management system, achieving 100% training qualification for employees and 100% compliance with registered process requirements[157] - The company has passed multiple certifications including China GMP, US FDA, Brazil, and EU certifications, and has undergone numerous audits and inspections by domestic and international regulatory bodies[157] - The company was listed among the top 500 manufacturing enterprises in Guangdong in 2023 and recognized as a "Specialized and Sophisticated" enterprise in Shenzhen[157] - The company's Wuhan subsidiary was awarded the title of "Outstanding Advanced Manufacturing Enterprise" in Huangpi District[157] Shareholder and Stock Information - The company canceled 33,685,704 shares in 2023, reducing the total number of shares from 699,719,517 to 666,033,813[72] - The proportion of restricted shares increased from 23.69% to 24.59% in 2023[71] - The top three shareholders, Zeng Shaogui, Zeng Shaoqiang, and Zeng Shaobin, held a total of 217,207,523 restricted shares at the end of 2023[74] - The company plans not to distribute cash dividends, issue bonus shares, or convert capital reserve into share capital[40] Government Subsidies and Non-Recurring Items - Government subsidies recognized in 2023 were 49,872,754.40 thousand yuan, a significant increase from 25,754,136.38 thousand yuan in 2022 and 46,683,413.96 thousand yuan in 2021[90] - The company's total non-recurring gains and losses in 2023 were 77,037,520.69 thousand yuan, compared to -56,025,540.62 thousand yuan in 2022 and 430,777,698.31 thousand yuan in 2021[91] - The company's financial assets and liabilities generated a fair value change and disposal gain of 31,511,232.36 thousand yuan in 2023, compared to losses of -82,559,111.99 thousand yuan in 2022 and -19,006,481.51 thousand yuan in 2021[91] - The company's other non-operating income and expenses in 2023 were -1,788,927.17 thousand yuan, compared to -1,517,471.56 thousand yuan in 2022 and -5,220,011.58 thousand yuan in 2021[91] - The company's long-term equity investment conversion to financial instruments generated an investment income of 376,846,594.64 thousand yuan in 2021[91] - The company's income tax impact in 2022 was 589,461.21 thousand yuan, compared to 3,252,501.84 thousand yuan in 2021[91] - The minority shareholders' equity impact in 2022 was 27,503.60 thousand yuan, compared to 267,674.91 thousand yuan in 2021[91] Intellectual Property and Patents - The company has nearly 400 domestic patents and dozens of international patents, and was recognized as an intellectual property advantage enterprise in 2022[133] - The company obtained 20 domestic patents in 2023, including patents for GLP-1 analog salt conversion and purification methods, as well as a solid-phase synthesis method for disulfide-bonded peptide drugs[170][172][173] - The parent company holds 277 domestic patents, including 271 invention patents, as of December 31, 2023[196] - A fully automatic injection pen was patented by Gansu Chengji Bio-Pharmaceutical Co., Ltd. in December 2016[200] Product Portfolio and Market Position - The company has 28 peptide drugs, 9 new drug certificates, and 31 clinical approvals, with a leading domestic market share for products like Terlipressin for Injection and Somatostatin for Injection[135] - The company's peptide API business is expected to grow steadily as global API market recovers and peptide drug patents expire, with 16 US DMFs, 5 EU DMFs, 5 EU CEPs, and 14 China DMFs[127] - Hanbei® Atosiban Acetate Injection received EU market approval in 2020 and passed the generic drug consistency evaluation in 2022[126] - The company has 16 products that have passed the generic drug consistency evaluation, including 11 peptide injections and 5 small molecule solid preparations[135] - The company's Desmopressin Acetate Injection is listed in the essential drug catalog and has advantages in market promotion[122] - The company's Carbetocin Injection has higher bioavailability and longer-lasting effects compared to traditional oxytocin, reducing the need for additional therapeutic uterotonics[124] - The company's Oxytocin Injection is a fourth-generation product with higher purity and fewer adverse reactions, meeting the 2015 Pharmacopoeia standards[123] - The company has established a high technical barrier in peptide API synthesis with over 20 years of experience, and strong customer loyalty, especially for products like Liraglutide[127] - The company implements strict quality control measures and risk management systems to ensure product quality and safety, including regular internal inspections and risk assessments[137] - Vildagliptin tablets are approved for monotherapy when diet and exercise fail to control blood sugar, and for combination therapy with metformin, insulin, or sulfonylureas when these treatments alone are insufficient[188] - Octreotide acetate injection is approved for controlling symptoms in acromegaly patients and treating bleeding from esophageal varices in cirrhosis patients[188] - Oxytocin injection passed consistency evaluation in March 2023[189]