中泰证券股份有限公司 关于北京诺思兰德生物技术股份有限公司 2023年度向特定对象发行股票 之 发行保荐书（修订稿） 保荐机构（主承销商） （山东省济南市经七路 86 号） 二〇二三年八月 北京诺思兰德生物技术股份有限公司 发行保荐书 保荐机构及保荐代表人声明 中泰证券股份有限公司（以下简称"中泰证券"、"保荐机构"或"本保荐机构"） 接受北京诺思兰德生物技术股份有限公司（以下简称"公司"、"发行人"或"诺思 兰德"）的委托，担任其向特定对象发行股票的保荐机构，并指定丁邵楠、王作 维担任本次保荐工作的保荐代表人。中泰证券及保荐代表人特作出如下承诺： 中泰证券及其保荐代表人根据《中华人民共和国公司法》（以下简称"《公 司法》"）、《中华人民共和国证券法》（以下简称"《证券法》"）、《北京证 券交易所上市公司证券发行注册管理办法》（以下简称"《发行注册管理办法》"）、 《证券发行上市保荐业务管理办法》《北京证券交易所证券发行上市保荐业务管 理细则》等有关法律、法规和中国证监会的有关规定，诚实守信，勤勉尽责，严 格按照依法制订的业务规则、行业执业规范和道德准则出具本发行保荐书，并保 证所出具文件的真实性、准确性和完 ...

证券代码：430047 证券简称：诺思兰德 公告编号：2023-079 北京诺思兰德生物技术股份有限公司 关于公司获得药品注册证书的公告 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记 载、误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承担个 别及连带法律责任。 北京诺思兰德生物技术股份有限公司（以下简称"公司"）收到国家药品监督 管理局核准签发的《药品注册证书》，现将相关情况公告如下： 一、 药品基本情况 药品名称：地夸磷索钠滴眼液 Diquafosol Sodium Eye Drops 证书编号：2023S01271 剂型：眼用制剂 注册分类：化学药品 4 类 批准文号：国药准字 H20234037 药品有效期：18 个月 处方药/非处方药：处方药 药品批准文号有效期：至 2028 年 08 月 07 日 上市许可持有人：北京诺思兰德生物技术股份有限公司 药品生产企业：北京汇恩兰德制药有限公司 二、 药品相关情况 地夸磷索钠滴眼液适用于经诊断为伴随泪液异常的角结膜上皮损伤的干眼 患者。地夸磷索钠系二核苷酸衍生物，通过作用于结膜组织以及杯状细胞膜上的 P2Y2受体，使细胞内钙离 ...

本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假记载、 误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连 带法律责任。 一、 说明会类型 北京诺思兰德生物技术股份有限公司（以下简称"公司"）于 2023 年 4 月 26 日 在 北 京 证 券 交 易 所 信 息 披 露 平 台 （ www.bse.cn ）、《 中 国 证 券 报 》 （www.cs.com.cn）披露了《2022 年年度报告》（公告编号：2023-006）及《2022 年年度报告摘要》（公告编号：2023-007），为方便广大投资者更深入了解公司 2022 年年度经营业绩的具体情况，加强与投资者的互动交流，公司拟召开 2022 年年度报告业绩说明会。 证券代码：430047 证券简称：诺思兰德 公告编号：2023-038 北京诺思兰德生物技术股份有限公司 2022 年度报告业绩说明会预告公告 二、 说明会召开的时间、地点 （一）会议召开时间：2023 年 5 月 15 日（星期一）15：00-17：00。 （二）会议召开地点 本次年度报告业绩说明会将采用网络远程的方式举行，投资者可登陆全景网 "投资者关 ...

Financial Performance - Net profit attributable to shareholders for Q1 2023 was CNY -15,653,304.13, a decline from CNY -10,980,188.46 in Q1 2022[10] - Operating revenue for Q1 2023 decreased by 15.84% year-on-year to CNY 12,385,343.25[10] - Total operating revenue for Q1 2023 was 12,385,343.25, down from 14,717,202.56 in Q1 2022, representing a decrease of approximately 15.9%[37] - Operating profit for Q1 2023 was -15,839,424.18, compared to -10,035,133.34 in Q1 2022, indicating a worsening of approximately 57.5%[38] - Net profit for Q1 2023 was -15,153,590.93, compared to -9,742,415.66 in Q1 2022, reflecting an increase in net loss of about 55.1%[39] - Total comprehensive income for Q1 2023 was -15,471,427.08, compared to -10,101,262.36 in Q1 2022, indicating a decline of approximately 53.5%[39] Assets and Liabilities - Total assets as of March 31, 2023, amounted to CNY 351,836,722.56, representing a 1.91% increase compared to the end of 2022[10] - The total liabilities to total assets ratio (consolidated) increased to 35.44% from 30.75% at the end of 2022[10] - Total liabilities rose from ¥106,169,377.54 to ¥124,700,520.41, indicating an increase of approximately 17.5%[31] - The company's total equity decreased from ¥239,061,903.61 to ¥227,136,202.15, a decline of about 5%[31] - The current liabilities increased from ¥70,235,680.32 to ¥88,700,269.75, reflecting an increase of about 26.4%[30] Cash Flow - The company's cash flow from operating activities showed a net outflow of CNY -6,283,074.74, a decrease of CNY 8,010,371.24 from the previous year[13] - Operating cash flow for Q1 2023 was negative at -6,283,074.74 CNY, a significant decline compared to 1,727,296.50 CNY in Q1 2022[44] - The company reported a net cash outflow of -37,432,429.72 CNY in Q1 2023, compared to a net increase of 30,446,012.61 CNY in Q1 2022[45] - The net cash flow from operating activities for the parent company was -13,700,757.54 CNY in Q1 2023, worsening from -1,399,867.82 CNY in Q1 2022[47] Expenses - Research and development expenses increased by CNY 489,970.00 compared to the same period last year, primarily due to ongoing projects[12] - Total operating costs increased to 28,456,394.01 in Q1 2023 from 24,974,211.23 in Q1 2022, an increase of about 14.9%[37] - Research and development expenses rose significantly to 13,449,259.47 in Q1 2023 from 8,549,566.51 in Q1 2022, marking an increase of approximately 57.5%[38] - The company reported a significant increase in management expenses to 6,402,274.04 in Q1 2023 from 6,683,383.54 in Q1 2022, a decrease of about 4.2%[38] - The company experienced a decrease in sales expenses to 2,936,809.45 in Q1 2023 from 5,747,213.40 in Q1 2022, a reduction of approximately 48.9%[38] Shareholding and Ownership - The company reported a total shareholding of 137,694,244 shares, representing 53.43% of the total shares outstanding[22] - The largest shareholder, Xu Songshan, holds 36,566,730 shares, accounting for 14.19% of the total[20] - Xu Rishan, another significant shareholder, holds 29,325,957 shares, representing 11.38% of the total[20] - The company experienced a decrease of 1,676,482 shares in total shareholding during the reporting period[22] Other Information - The company has no ongoing litigation or arbitration matters during the reporting period[25] - There were no external guarantees or loans provided by the company during the reporting period[25] - The company has implemented an employee stock ownership plan, which was approved by the shareholders[25] - The company has fulfilled its previously disclosed commitments in a timely manner[25] - There are no significant related party transactions reported during the period[25] - The company has not faced any investigations or penalties during the reporting period[25]

Clinical Trials and Drug Development - In 2022, the company completed the enrollment and data analysis for the Phase IIa clinical trial of the innovative drug NL005 for acute myocardial infarction, and officially launched the Phase IIb clinical trial in June[6]. - The NL003 clinical trial has enrolled over 70% of the total required participants for its Phase III trial, while the NL005 project has successfully completed its Phase IIa summary and is moving into Phase IIb[53]. - The company is developing 11 biopharmaceutical projects targeting 13 indications, with 5 gene therapy drugs and 6 recombinant protein drugs[48]. - The company is focused on developing gene-engineered protein drugs, gene therapy drugs, and ophthalmic medications[27]. - The company is advancing several new drug candidates, including NL201 and NL202 for hemophilia treatment, which could fill market gaps and enhance competitiveness[107][108]. - The company is also developing a DNA vaccine for SFTS, which could provide reliable prevention for at-risk populations, enhancing its core competitiveness[108]. - The company is developing multiple eye drop products, including NL403 for dry eye treatment, which has received approval for drug registration and is expected to enhance sales revenue[109]. - The company is in the R&D phase for NL406, a non-steroidal anti-inflammatory eye drop, which has a broad market potential once developed successfully[110]. - The company is developing a nano-emulsion formulation for cyclosporine eye drops (NL301), aimed at improving patient compliance and comfort in dry eye treatment[110]. Financial Performance - The company's operating revenue for 2022 was ¥64,654,602.85, representing a year-over-year increase of 13.72% compared to ¥56,855,880.53 in 2021[34]. - The net profit attributable to shareholders was ¥67,616,828.07 in 2022, up from ¥51,566,652.08 in 2021[34]. - The gross profit margin decreased to 64.95% in 2022 from 73.33% in 2021[34]. - The company reported a net profit margin decline of 99.79%, with a net loss of ¥50,528,453.94, attributed to increased costs and changes in revenue recognition[70]. - The company's main business revenue for 2022 was ¥63,838,976.44, an increase of 12.65% compared to ¥56,670,257.52 in 2021[74]. - The company achieved drug sales and processing income of 64.65 million yuan from its subsidiary, meeting its annual operational goals[57]. - The company reported a cash flow from operating activities of -¥24,238,493.18 in 2022, an improvement from -¥26,917,992.07 in 2021[38]. - The accounts receivable turnover ratio improved to 9.35 in 2022 from 6.02 in 2021[38]. Research and Development - The company has added 7 domestic invention patents in 2022, enhancing its intellectual property protection and core competitiveness in technology innovation[7]. - R&D expenditure increased by 30.57% compared to the previous period, amounting to ¥56,404,780.15, which represents 87.24% of operating revenue[100][102]. - The total number of R&D personnel rose from 44 to 47, with the proportion of R&D staff to total employees increasing from 31.13% to 32.59%[103]. - The company has developed a rich pipeline of gene therapy and recombinant protein drugs, with a total of 28 patents granted (23 domestic and 5 international)[49]. - The company is committed to increasing R&D investment, particularly for drugs that have entered clinical stages, to expedite their market entry[127]. Risks and Challenges - The company has not yet achieved profitability and faces cumulative unremedied losses due to significant investments in innovative drug research and development[14]. - The company is exposed to risks related to drug research and development, including potential failures in clinical trials and regulatory approval processes[13]. - The company faces commercialization risks due to potential inaccuracies in third-party data regarding disease prevalence and market acceptance of its drugs[18]. - Regulatory changes in the pharmaceutical industry may increase operational and research costs, impacting the company's business if it fails to adapt[20]. - The company’s clinical trial progress may be affected by patient recruitment challenges and adjustments in clinical trial protocols[17]. Corporate Governance and Shareholder Information - The company has appointed Zhongzheng Yatai Accounting Firm as its auditor for the reporting period[30]. - The company’s actual controllers are Xu Songshan and Xu Rishan, who are also the major shareholders[28]. - The largest shareholder, Xu Songshan, holds 36,566,730 shares, representing 14.19% of total shares[166]. - The second-largest shareholder, Xu Rishan, holds 29,325,957 shares, accounting for 11.38% of total shares[166]. - The company has 7,354 shareholders as of the end of the reporting period[164]. - The company has no significant litigation or arbitration matters during the reporting period[145]. - The company has no major related party transactions during the reporting period[145]. Market Outlook and Industry Trends - The biopharmaceutical market in China is expected to grow at a compound annual growth rate (CAGR) of 14.3% from 2020 to 2025, reaching a market size of 674.4 billion yuan by 2025[59]. - The biopharmaceutical industry is considered one of the most promising sectors for development in the 21st century, with significant government support and a growing market[59]. - The Chinese pharmaceutical market reached RMB 1.6 trillion in 2020, with a projected CAGR of 6.8%, expected to grow to RMB 2.3 trillion by 2025[122]. - The biopharmaceutical sector experienced a CAGR of 17.1% from 2016 to 2020, with an anticipated CAGR of 14.3% from 2020 to 2025, reaching RMB 674.4 billion by 2025[122]. Stock and Equity Information - The company’s registered capital increased from 257,250,203 shares to 257,718,203 shares due to the exercise of stock options[148]. - A total of 760,000 stock options were granted under the equity incentive plan, with 1,505,000 restricted shares released from restrictions during the reporting period[147]. - The total number of stock options and restricted shares granted but not exercised by the end of the reporting period is 5,337,000 shares[147]. - The company has implemented an employee stock ownership plan involving 36 individuals, excluding supervisors and independent directors[147]. - The company has pledged to strictly adhere to its profit distribution policy, ensuring timely disclosure of any failure to comply with the policy[154]. Construction and Industrialization Projects - The total contract amount for the construction project of the biopharmaceutical industrialization project signed with China Construction Installation Group was 103.5 million yuan, which commenced in June 2022[6]. - The company has initiated the construction of a biopharmaceutical industrialization project, with over 80% of the steel structure installation completed[55]. - The company has a total of 7,900,000.00 yuan in restricted cash, accounting for 2.29% of total assets, due to a performance guarantee for a construction contract[159]. - The company has not experienced any significant operational impact from the issuance of performance guarantees related to the construction contract[160].

Financial Performance - The company expects a net loss for the reporting period, estimated between -72 million to -60 million CNY, compared to a net loss of -51.57 million CNY in the same period last year[2] - The primary reason for the significant loss is the ongoing research and development of biopharmaceuticals, which has not yet resulted in product sales, despite an increase in revenue from ophthalmic drugs[3] - The financial data provided is preliminary and has not been audited by an accounting firm, emphasizing the need for investors to be cautious[4]

Financial Performance - The company achieved operating revenue of ¥64,654,602.85, representing a year-on-year increase of 13.72%[5] - The net profit attributable to shareholders was -¥67,616,828.07, indicating a continued loss compared to the previous year[5] - The net profit attributable to shareholders after deducting non-recurring gains and losses was -¥70,703,823.19[5] - Basic earnings per share were -¥0.26, a decline from -¥0.20 in the previous year[5] - Total assets at the end of the reporting period were ¥345,231,281.15, a decrease of 1.53% year-on-year[5] - Shareholders' equity attributable to the company was ¥198,440,667.75, down 18.10% compared to the previous year[5] - The net asset value per share attributable to shareholders was ¥0.77, reflecting an 18.09% decrease year-on-year[5] Research and Development - The increase in research and development expenses was due to the initiation of clinical phase IIb for the new drug "Recombinant Human Thymosin β4"[6] - The company continues to operate at a loss as innovative drugs have not yet received commercial sales approval[6] Market Trends - The market penetration of ophthalmic drugs has been increasing, contributing to steady revenue growth in this segment[6]

证券代码：430047 证券简称：诺思兰德 公告编号：2022-091 北京诺思兰德生物技术股份有限公司 关于接待机构投资者调研情况的公告 | --- | |--------------------------------------------------------------------| | | | 本公司及董事会全体成员保证公告内容的真实、准确和完整，没有虚假 | | 记载、误导性陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承 | | 担个别及连带法律责任。 | 北京诺思兰德生物技术股份有限公司（以下简称"公司"）于 2022 年 11 月 30 日至 2022 年 12 月 2 日接待了 38 家机构的调研，现将主要情况公告如 下： 一、 调研情况 调研时间：2022 年 11 月 30 日至 2022 年 12 月 02 日 调研形式：网络调研 调研机构：泰康基金、兴业基金、华商基金、融通基金等 38 家机构投资者。 上市公司接待人员：副总经理韩成权先生、财务总监兼董事会秘书高洁女士。 二、 调研的主要问题及公司回复概要 问题 1：裸制粒进入人体内会有抗体产生吗？ 目前未观察到相关抗体的 ...