证券研究报告 | 2024年09月13日 绿竹生物-B（02480.HK） 优于大市 候选重组带状疱疹疫苗国内 Ph3 临床进行中 加大研发投入，LZ901 国内 Ph3 临床进行中。2024H1，公司经调整亏损 1.10 亿元，上年同期为亏损 0.79 亿元。2024H1，研发开支为 0.80 亿元（同 比+142.4%），主要由于在中国开展 LZ901 的 Ph3 临床试验；行政开支为 0.45 亿元（同比+9.0%），主要由于部分建设项目完成导致物业、厂房及设 备折旧增加。 LZ901：重组带状疱疹候选疫苗，是公司核心管线之一，有望成为全球首款 具有四聚体分子结构的带状疱疹疫苗，用于预防 50 岁及以上成人由水痘－ 带状疱疹病毒（VZV）引起的带状疱疹。公司于2023年9月在中国启动LZ901 的多中心、随机、双盲、安慰剂对照 Ph3 临床研究，并于 2024 年 1 月在江 苏、山东、湖北及山西四省完成共计 2.6 万名 40 岁及以上健康受试者入组。 公司预计不晚于2025年1 月提交BLA申请，并于2025Q4 实现产品商业化。 K3：重组人抗肿瘤坏死因子（TNF）-α单克隆抗体注射剂在研产品，也 ...

证券研究报告 | 2024年09月13日 绿竹生物-B（02480.HK） 优于大市 候选重组带状疱疹疫苗国内 Ph3 临床进行中 加大研发投入，LZ901 国内 Ph3 临床进行中。2024H1，公司经调整亏损 1.10 亿元，上年同期为亏损 0.79 亿元。2024H1，研发开支为 0.80 亿元（同 比+142.4%），主要由于在中国开展 LZ901 的 Ph3 临床试验；行政开支为 0.45 亿元（同比+9.0%），主要由于部分建设项目完成导致物业、厂房及设 备折旧增加。 LZ901：重组带状疱疹候选疫苗，是公司核心管线之一，有望成为全球首款 具有四聚体分子结构的带状疱疹疫苗，用于预防 50 岁及以上成人由水痘－ 带状疱疹病毒（VZV）引起的带状疱疹。公司于2023年9月在中国启动LZ901 的多中心、随机、双盲、安慰剂对照 Ph3 临床研究，并于 2024 年 1 月在江 苏、山东、湖北及山西四省完成共计 2.6 万名 40 岁及以上健康受试者入组。 公司预计不晚于2025年1 月提交BLA申请，并于2025Q4 实现产品商业化。 K3：重组人抗肿瘤坏死因子（TNF）-α单克隆抗体注射剂在研产品，也 ...

公司深度分析 2024 年 09 月 09 日 绿竹生物-B(02480.HK) 证券研究报告 生物技术(HS) 投资评级 买入-A 首次评级 6 个月目标价 32.77 港元 股价 (2024-09-05) 21.50 港元 交易数据 总市值(百万港元) 4,352.65 流通市值(百万港元) 4,352.65 总股本(百万股) 202.45 流通股本(百万股) 202.45 12 个月价格区间 17.22/39.0 港元 LZ901 三期进行时，剑指百亿蓝海市场 绿竹生物：深耕行业二十余年，以创新驱动发展。绿竹生物成立于 2001 年 11 月，是一家致力于开发创新型人用疫苗和治疗性生物制剂 的生物技术公司。公司创始人孔健先生曾供职于卫生部北京生物制品 研究所，拥有 30 多年的生物制药行业经验，作为首席科学家带领公 司研究团队实现多项突破，自成立以来成功研发了 6 款疫苗产品，其 中液体 AC 流脑结合疫苗、AC-Hib 三联疫苗为全球首款，Hib 结合疫 苗（磷酸铝佐剂）、ACYW135 流脑多糖疫苗为中国首款，6 款疫苗均已 转让给智飞生物，其中 5 款疫苗已实现商业化。目前，公司共布局了 7 款在 ...

公司深度分析 2024 年 09 月 09 日 绿竹生物-B(02480.HK) 证券研究报告 生物技术(HS) 投资评级 买入-A 首次评级 6 个月目标价 32.77 港元 股价 (2024-09-05) 21.50 港元 交易数据 总市值(百万港元) 4,352.65 流通市值(百万港元) 4,352.65 总股本(百万股) 202.45 流通股本(百万股) 202.45 12 个月价格区间 17.22/39.0 港元 LZ901 三期进行时，剑指百亿蓝海市场 绿竹生物：深耕行业二十余年，以创新驱动发展。绿竹生物成立于 2001 年 11 月，是一家致力于开发创新型人用疫苗和治疗性生物制剂 的生物技术公司。公司创始人孔健先生曾供职于卫生部北京生物制品 研究所，拥有 30 多年的生物制药行业经验，作为首席科学家带领公 司研究团队实现多项突破，自成立以来成功研发了 6 款疫苗产品，其 中液体 AC 流脑结合疫苗、AC-Hib 三联疫苗为全球首款，Hib 结合疫 苗（磷酸铝佐剂）、ACYW135 流脑多糖疫苗为中国首款，6 款疫苗均已 转让给智飞生物，其中 5 款疫苗已实现商业化。目前，公司共布局了 7 款在 ...

Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 9,732,000, representing an increase of 82.3% compared to RMB 5,339,000 for the same period in 2023[17]. - The group reported a pre-tax loss of RMB 109,938,000 for the six months ended June 30, 2024, a 38.5% increase from RMB 79,352,000 in 2023[30]. - Other income increased by approximately 82.3% from RMB 5.3 million for the six months ended June 30, 2023, to RMB 9.7 million for the six months ended June 30, 2024, primarily due to unconditional government subsidies[31]. - The company reported a net loss attributable to shareholders of RMB 109,938,000 for the six months ended June 30, 2024, compared to a loss of RMB 79,352,000 for the same period in 2023, representing an increase in loss of approximately 38.7%[92]. - Basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.54, compared to RMB 0.41 for the same period in 2023, representing a 31.7% increase in loss per share[75]. Research and Development - R&D expenses surged by 142.4% to RMB 80,376,000 from RMB 33,157,000 year-over-year[17]. - The company has developed an innovative antigen delivery technology aimed at enhancing the immunogenicity of vaccine candidates[19]. - The core product LZ901 is part of a pipeline that includes three clinical-stage products and four preclinical-stage products as of June 30, 2024[18]. - The group aims to expand its product pipeline through independent development and collaborations, focusing on clinical development of LZ901, K3, and K193[29]. - The company is focused on the development of its core product LZ901, a recombinant varicella-zoster virus vaccine, which is currently in the research phase[113]. Clinical Trials and Product Pipeline - A Phase III clinical trial for LZ901 has been initiated in China with 26,000 participants aged 40 and above, expected to complete enrollment by January 2024[20]. - K3, a biosimilar to Humira, has completed Phase I trials in China and is set to initiate Phase III trials in 2025[22]. - K193, a bispecific antibody for B-cell leukemia and lymphoma, is in Phase I trials, expected to complete by 2025[23]. - As of June 30, 2024, the group has four products in preclinical stages, including recombinant vaccines for chickenpox and RSV[24]. Financial Position - The total non-current assets as of June 30, 2024, were RMB 536,879,000, a slight decrease from RMB 545,722,000 at the end of 2023[17]. - Cash and bank balances decreased by approximately RMB 77.3 million from RMB 265.0 million as of June 30, 2023, to RMB 187.7 million as of June 30, 2024, primarily due to increased R&D expenditures[41]. - The total assets as of June 30, 2024, were RMB 1,007,513,000, down from RMB 1,070,382,000 as of December 31, 2023, indicating a decrease of 5.9%[76]. - The company's net assets decreased to RMB 944,193,000 as of June 30, 2024, from RMB 1,020,628,000 at the end of 2023, a reduction of 7.5%[76]. - The debt-to-asset ratio was 14.3% as of June 30, 2024, compared to 12.5% as of December 31, 2023[44]. Corporate Governance and Shareholder Information - The company is committed to maintaining high standards of corporate governance to protect shareholder interests[65]. - The company has a significant ownership structure, with Mr. Kong holding a beneficial interest of 28.79% in the company[55]. - The major shareholder, Hengqin Green Bamboo Limited Partnership, holds 12,307,500 shares, representing 6.08% of the total issued share capital[59]. - The company has no directors or senior management with interests in the company's shares or related securities as of June 30, 2024[57]. - The company is focused on enhancing its operational efficiency and financial performance through strategic initiatives and investments[112]. Employee and Operational Insights - As of June 30, 2024, the company employed 148 full-time employees, with 58.8% in R&D roles[51][52]. - Total employee costs increased to RMB 48,752,000 in the first half of 2024, up from RMB 47,410,000 in the same period of 2023, reflecting a rise of about 2.8%[90]. - The company emphasizes employee training to enhance technical and product knowledge across various positions[51]. Future Outlook and Strategic Initiatives - The company plans to submit a Biologics License Application (BLA) for LZ901 to the National Medical Products Administration by January 2025, with commercialization targeted for Q4 2025[20]. - The company is exploring potential mergers and acquisitions to strengthen its competitive position in the industry[112]. - The company plans to continue its research and development efforts to innovate and introduce new products to the market[113].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Beijing Luzhu Biotechnology Co., Ltd. 北京綠竹生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2480） 截至2024年6月30日止六個月的中期業績公告 北京綠竹生物技術股份有限公司（「本公司」）董事（「董事」）會（「董事會」）欣然宣 佈本公司及其附屬公司（統稱「本集團」）截至2024年6月30日止六個月（「報告期 間」）的未經審核簡明綜合中期業績連同2023年相應期間的比較數字。 1 | --- | --- | --- | --- | |------------------------|--------------------------------------------------|------------------------------------------------------------|----------| | ...

证券研究报告 | 2024年04月25日 绿竹生物 （ ） 增持 -B 02480.HK 核心管线 三期临床有序推进 LZ901 核心观点 公司研究·财报点评 加大研发投入，在研管线有序推进。2023年公司经调整亏损2.23亿元，上 医药生物·生物制品 年同期为亏损1.52亿元。其中，2023全年研发开支为1.73亿元（同比 证券分析师：张佳博 证券分析师：陈益凌 +88.9%），主要由于在中国开展LZ901的Ph3临床试验；行政开支为0.86 021-60375487 021-60933167 zhangjiabo@guosen.com.cnchenyiling@guosen.com.cn 亿元（同比+1.4%），主要由于员工成本、折旧及其他开支增加，部分被股 S0980523050001 S0980519010002 权激励的摊销减少所抵消。 证券分析师：马千里 010-88005445 LZ901（重组带状疱疹疫苗）：于2023年9月在中国启动LZ901的多中心、 maqianli@guosen.com.cn 随机、双盲、安慰剂对照Ph3临床研究，并于2024年1月在江苏、山东、 S0980521070 ...

Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 20,085,000, an increase of 44.3% compared to RMB 13,923,000 in 2022[5]. - The company reported a pre-tax loss of RMB 249,350,000, a significant reduction of 65.6% from a loss of RMB 725,180,000 in 2022[5]. - Other income increased by approximately 44.3% from RMB 13.9 million in 2022 to RMB 20.1 million in 2023, primarily due to increased interest income from bank deposits[27]. - The company reported a significant reduction in other expenses, decreasing approximately 80.8% from RMB 3.1 million in 2022 to RMB 0.6 million in 2023[29]. - The net other income increased by approximately 20.3% from RMB 15.1 million in 2022 to RMB 18.2 million in 2023, mainly due to an increase in foreign exchange gains[31]. - The group's pre-tax loss decreased by approximately 65.6% to RMB 249,400,000 for the year ended December 31, 2023, compared to RMB 725,200,000 in 2022[38]. - The liquidity position improved with cash and bank balances increasing from approximately RMB 69,000,000 in 2022 to approximately RMB 265,000,000 in 2023, primarily due to net proceeds from the global offering[43]. - The group incurred listing expenses of approximately RMB 26,500,000 for the year ended December 31, 2023, an increase of approximately 22.8% from RMB 21,500,000 in 2022[37]. Research and Development - Research and development expenses rose to RMB 172,685,000, an increase of 88.9% from RMB 91,426,000 in the previous year[5]. - The company has three clinical-stage products in its pipeline, including the core product LZ901, and four preclinical-stage products[8]. - The company achieved a significant milestone in its R&D pipeline with advancements in multiple products during 2023[9]. - The company plans to actively promote the clinical development of its pipeline drugs, including LZ901, K3, and K193, and accelerate the development of other preclinical products[25]. - The company has established comprehensive internal product discovery capabilities, covering all stages of drug development from preclinical research to manufacturing[22]. - The company is focused on developing innovative human vaccines and therapeutic biological products to prevent and control infectious diseases and treat cancer and autoimmune diseases[76]. - The company is committed to research and development in the field of immunology and protein engineering[76]. - The company has initiated preclinical research for a recombinant RSV vaccine targeting lower respiratory diseases[197]. Clinical Trials and Product Development - The company completed the Phase II clinical trial of LZ901 in China in May 2023 and initiated the Phase III trial in September 2023, involving approximately 26,000 participants, with the first dose expected to be administered by December 2023[10]. - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in China in the second half of 2024, with commercialization anticipated in 2026[17]. - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, is expected to complete its Phase I clinical trial by the second quarter of 2024[18]. - The Phase II clinical trial of LZ901 showed significant immunogenicity, with the geometric mean concentration (GMC) and geometric mean titer (GMT) of the high-dose group significantly higher than the low-dose group and the placebo group[15]. - The company has decided to suspend the development of the recombinant rabies vaccine and reallocate resources to the recombinant RSV vaccine, which is currently in the preclinical stage[19]. Production and Facilities - The new production facility in Guangdong covers an area of approximately 120,000 square meters, with 72,000 square meters of production space completed, and is expected to provide an annual capacity of no less than 20 million doses of biological products[11]. - The company received the Drug Production License from the Guangdong Provincial Drug Administration in January 2023, ensuring future commercialization of human vaccines[11]. - The group reported a debt-to-asset ratio of 12.5% as of December 31, 2023, slightly up from 12.4% in 2022[44]. - The group has entered into a construction contract for a new R&D and manufacturing facility with a total construction area of approximately 45,072.87 square meters, expected to enhance its operational capacity[47]. Corporate Governance and Management - The company is led by experienced executives, including Mr. Kong Jian, who has over 35 years in the biopharmaceutical industry and has developed five commercialized vaccines[58]. - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring a balanced composition for independent judgment[136]. - The company has established mechanisms to ensure the board receives independent viewpoints, enhancing its ability to protect shareholder interests[139]. - The company has implemented effective procedures for the appointment and re-election of directors, with a term of three years[143]. - The company has established a remuneration committee to determine the remuneration policy for directors and senior management[100]. - The company has adopted a standard code of conduct for securities trading by its directors and supervisors, confirming compliance for the year ended December 31, 2023[154]. - The company emphasizes compliance with legal and regulatory policies as part of its corporate governance responsibilities[156]. Shareholder Information - The total issued share capital of the company as of December 31, 2023, is 202,449,032 shares, comprising 142,719,736 H shares and 59,729,296 non-listed shares[113]. - The company has a significant shareholder, Yitang Saiying, holding approximately 26.60% of the H shares, which equates to 37,969,696 shares[110]. - The employee incentive plan was adopted on December 15, 2021, and all rights under this plan were granted prior to the company's listing[115]. - The company has a diverse shareholder base, with multiple entities holding substantial percentages of H shares, indicating strong institutional interest[110]. - The company has confirmed that there are no other disclosures required under the Securities and Futures Ordinance regarding interests or short positions in shares or related securities[108]. Risks and Challenges - The company has faced major risks and uncertainties, which are discussed in the management discussion and analysis section of the report[78]. - The company anticipates that a majority of its future vaccine products will be sold to China's CDC, exposing it to uncertainties related to government funding and budget processes[81]. - The company may require additional financing to support its R&D and operational expansion, which it may not be able to secure[87]. - The company faces potential liability during the R&D process, particularly from product liability claims or lawsuits[80]. - The company is subject to strict regulations regarding the R&D, manufacturing, and commercialization of its products, which may impact its approval processes[85]. Environmental, Social, and Governance (ESG) - The first Environmental, Social, and Governance (ESG) report was published, detailing the company's management, practices, and performance in ESG matters[189]. - The company aims to maintain transparency and effective communication with investors through various channels, including regular reports and announcements[186]. - The company emphasizes the integration of ESG factors into its operations and decision-making processes[193]. - The company will continue to uphold gender diversity within its workforce[179].

Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 20,085,000, an increase of 44.3% compared to RMB 13,923,000 in 2022[2] - The company reported a pre-tax loss of RMB 249,350,000, a reduction of 65.6% compared to a loss of RMB 725,180,000 in 2022[2] - The net loss for the year was RMB 249,350,000, down from RMB 725,180,000 in the previous year, reflecting a 65.6% improvement[3] - Basic and diluted loss per share for the year was RMB 1.25, compared to RMB 4.98 in 2022[3] - The group incurred a total loss before tax of RMB 249,350,000 for the year ended December 31, 2023, compared to a loss of RMB 725,180,000 in 2022, indicating an improvement in performance[15] - The adjusted loss for the period increased by approximately 46.6% to RMB 222,891,000 for the year ended December 31, 2023, compared to RMB 152,092,000 in 2022, primarily due to increased R&D expenses[66] Research and Development - Research and development expenses rose significantly to RMB 172,685,000, an increase of 88.9% from RMB 91,426,000 in the previous year[2] - The company successfully completed the Phase II clinical trial for LZ901 in China, with no serious adverse events reported[2] - The company plans to initiate a Phase III clinical trial for LZ901 in January 2024, involving approximately 26,000 participants across multiple provinces in China[2] - LZ901, a recombinant herpes zoster vaccine, has shown high immunogenicity and safety in clinical trials, with a geometric mean concentration (GMC) significantly higher in the high-dose group compared to the low-dose group[43] - The Phase II clinical trial of LZ901 was completed in May 2023, and the company plans to submit a Biologics License Application (BLA) to the National Medical Products Administration in Q4 2024[44] - The company has decided to suspend the development of its recombinant rabies vaccine and reallocate resources to the development of a recombinant respiratory syncytial virus (RSV) vaccine[40] - The company has established an innovative protein engineering platform to support the full cycle of drug development, enhancing its capabilities in developing human vaccines and monoclonal antibodies[41] - The company has received IND approval from the FDA for LZ901 and plans to complete the Phase I clinical trial in the U.S. by Q2 2024[44] - The company has three R&D patents and six pending applications related to its core product in China, Russia, and Japan[40] - The company’s proprietary dual-specific antibody development platform, Fabite®, offers competitive advantages in treating recurrent/refractory hematological malignancies[42] - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in China in the second half of 2024, with commercialization anticipated in 2026[45] - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, began Phase I clinical trials in China in December 2019, with completion expected in the second half of 2024[46] - The company has four products in preclinical stages, including the recombinant RSV vaccine, which is being prioritized over the rabies vaccine[47] Assets and Liabilities - The company’s total assets increased to RMB 1,070,382,000 as of December 31, 2023, compared to RMB 976,056,000 in 2022[4] - The company’s equity totalled RMB 1,020,628,000, up from RMB 937,466,000 in the previous year[4] - Non-current assets (excluding financial instruments) increased to RMB 545,391,000 as of December 31, 2023, from RMB 468,853,000 as of December 31, 2022[8] - Total property, plant, and equipment increased from RMB 258,046,000 as of December 31, 2022, to RMB 422,831,000 as of December 31, 2023, reflecting a growth of approximately 64%[19] - The company’s accumulated depreciation for property, plant, and equipment increased from RMB 28,419,000 in 2022 to RMB 38,926,000 in 2023[19] - The right-of-use assets increased from RMB 62,462,000 as of December 31, 2022, to RMB 104,591,000 as of December 31, 2023, showing a growth of approximately 67%[21] - The company has a lease liability of RMB 12,216 thousand as of December 31, 2023, which is slightly higher than RMB 11,219 thousand in the previous year, reflecting an increase of approximately 8.9%[33] - The company’s total liabilities related to lease obligations over five years decreased to RMB 5,036 thousand in December 2023 from RMB 6,770 thousand in December 2022, reflecting a decline of approximately 25.7%[33] Cash Flow and Financing - Cash and cash equivalents increased significantly to RMB 257,891 thousand as of December 31, 2023, compared to RMB 68,976 thousand in the previous year, marking an increase of approximately 274%[28] - The company obtained a new bank loan of RMB 10,000,000 in March 2023, with a remaining balance of RMB 7,000,000 after partial repayment in September 2023[36] - Cash and bank balances increased by approximately RMB 196,000,000 to RMB 265,000,000 as of December 31, 2023, from RMB 69,000,000 as of December 31, 2022, mainly due to net proceeds from the global offering[68] - The company completed a public offering on May 8, 2023, raising net proceeds of approximately HKD 241.6 million, equivalent to about RMB 300.18 million[40] - The net proceeds from the global offering amounted to approximately HKD 241.6 million, with no over-allotment option exercised as of May 8, 2023[73] Corporate Governance and Compliance - The company has complied with all applicable corporate governance codes since its listing date[80] - The audit committee reviewed the consolidated financial statements for the year ended December 31, 2023, and discussed matters related to auditing and internal controls[84] - Deloitte has agreed that the figures in the preliminary announcement are consistent with the audited financial statements to be approved on March 15, 2024[85] - The board does not recommend the payment of a final dividend for the year ended December 31, 2023[86] Employee and Operational Insights - A total of 133 full-time employees were employed as of December 31, 2023, with 54.2% in R&D[76] - The production team consists of 28 members, ensuring compliance with quality control standards and regulations[50] - The internal R&D team is involved in all stages of drug development, enhancing the company's capabilities in recombinant protein design and optimization[49] - The company maintains a conservative financing and treasury policy to ensure optimal financial condition and minimal financial risk[78] - The employee incentive plan adopted on December 15, 2021, does not involve the issuance of new shares but grants rights in a partnership[79] Future Plans and Strategic Initiatives - The company plans to expand production capacity to meet growing market demand and accelerate the clinical development of its pipeline products[51] - The company aims to promote the commercialization process both domestically and internationally through strategic planning and partnerships[51] - Funding for ongoing and planned clinical trials of LZ901 in China and the US is set at HKD 97.0 million (40.2%), with HKD 32.8 million already utilized[75] - The company plans to allocate HKD 53.4 million (22.1%) for clinical development and manufacturing of K3, with HKD 38.8 million (16.1%) specifically for planned clinical trials between 2023 and 2024[75]

Beijing Luzhu Biotechnology Co., Ltd. 股份代號 : 2480 （於中華人民共和國註冊成立的股份有限公司） 中 期 報 告 2023 目錄 | --- | --- | |-------|------------------------------| | | | | 2 | 公司資料 | | 4 | 財務及營運數據摘要 | | 5 | 公司簡介 | | 6 | 管理層討論及分析 | | 16 | 其他資料 | | 24 | 簡明綜合財務報表的審閱報告 | | 25 | 簡明綜合損益及其他全面收益表 | | 26 | 簡明綜合財務狀況表 | | 27 | 簡明綜合權益變動表 | | 28 | 簡明綜合現金流量表 | | 29 | 簡明綜合財務報表附註 | | 43 | 釋義及技術詞彙 | 公司資料 | --- | --- | |--------------------------------|---------------------------------| | | | | | | | | | | | | | 董事會 | 提名委員會 | | 執行董事 | 孔健先生 （主席） ...