Betta Pharmaceuticals Co., Ltd.(300558)
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贝达药业:2023年报及2024年一季报点评:商业化增长稳健,多款产品获批
华创证券· 2024-05-23 08:02
公司研 究 证 券研究 报 告 化学制剂 2024年05月23日 贝 达药业(300558)2023年报及 2024年一季报点评 强 推 (维持) 目标价:58.2元 商业化增长稳健,多款产品获批 当前价:39.40元 事项: 华创证券研究所 2023年,公司实现营业收入24.56亿元,同比增长3.35%;归母净利润为3.48 证券分析师:刘浩 亿元,同比增长139.33%;扣非归母净利润为2.63亿元,同比增长768.85%。 邮箱:liuhao@hcyjs.com 2024年第一季度,公司实现营业收入7.36亿元,同比增长38.40%;归母净利 润为9814万元,同比增长90.95%;扣非归母净利润为 8956万元,同比增长 执业编 号:S0360520120002 390.39%。 公司基本数据 评论: 总股本(万股) 41,848.59 多款产品获批并进入医保,迎来新营收增长点。公司已有5款产品上市,埃克 已上市流通股(万股) 41,715.60 替尼作为基石产品持续贡献营收,恩沙替尼继续放量,贝伐珠单抗注射液符合 总市值(亿元) 164.88 预期。2023年,3代EGFR-TKI贝福替 ...
商业化梯队逐渐丰富,2024年Q1销售实现恢复
兴业证券· 2024-05-08 01:32
公 司 研 证券研究报告 究 #industryId# 化学制剂 #investSuggestion# # #d 贝yCo 达mp 药any#业 ( 300558.SZ ) investSug 增持 ( 维ges持tion )Ch 00 商00 业09 化 梯 队逐渐丰富, #t 2it 0le 2# 4 年 Q1 销售实现恢复 ange# # createTime1# 2024年 05月 07日 投资要点 公 #市场ma数rk据et Data# # ⚫ sum 事ma 件ry# : 公司公布2023年年报,实现营业总收入24.56亿元(同比+3.35%), 司 日期 2024-05-06 实现归母净利润 3.48 亿元(同比+139.33%),实现扣非归母净利润 2.63 点 收盘价(元) 43.70 亿元(同比+768.85%)。公司公布2024年一季报,实现营业收入7.36亿 评 总股本(百万股) 418.49 元(同比+38.40%),实现归母净利润0.98亿元(同比+90.95%),实现扣 报 流通股本(百万股) 417.16 非归母净利润0.90亿元(同比+390.39%)。 净资产(百万元) 5 ...
贝达药业20240422
2024-04-23 22:18
那么今天很荣幸邀请到公司各板块的高管能够和大家进行一个交流那么今天出席的高管包括公司的资深副总裁兼首席运营官万总资深副总裁兼首席科学家王博行政总裁佟总副总裁兼首席财务官范总副总裁BP负责人李莹博士 副总裁纪总和我们熟悉的董秘吴总那么首先我们还是分别请几位业务线条的高管为我们简要介绍一下去年全年以及今年一季度的整体的经营情况和进展然后后续我们再进入问答的环节那么今天是属于我们的系统举办交流会那么各家的券商也在线 然后一会儿也欢迎大家多多提问那么首先我们邀请万总对销售这块进行一个介绍有请万总万总应该断线了马上你得重新播入一下好的好的马上外部一下 大家稍等 喂万总接入了吗我已经上线了刘总好的好的万总刚可能我介绍您没有听到就还是先请您介绍一下就是销售这块一些情况去年全年和今年一季度的嗯好的这个各位同事人各位这个关心贝达的同道大家好啊 这个我们刚刚在上周末发布了贝达的二零二三年的年报和今年二零二四年一季度的季报应该说呢从我们市场营销这架马车一直是按照我们董事会和股东的这个希望正在快马加鞭那么去年呢应该说贝达实现了从单产品运营向多产品运营的一个最大的变化就是从二零二三年开始 对他已经形成了呃五个产品的这样一个创新要有一个 ...
公司简评报告:利润端符合预期,新品上市放量可期
东海证券· 2024-04-23 04:00
公 司 研 究 [Table_Reportdate] 2024年04月23日 [Table_invest] [贝Tabl达e_N药ewT业itle] (300558):利润端符合预期, 买入(维持) 公 新品上市放量可期 司 报告原因:业绩点评 简 ——公司简评报告 评 [table_main] [证Ta券b分le析_A师u thors] 投资要点 杜永宏 S0630522040001 dyh@longone.com.cn ➢ 利润端符合预期,整体费用控制良好。2023年,公司实现营业收入24.56亿元(+3.35%)、 医 证券分析师 归母净利润3.48亿元(+139.33%),扣非归母净利润2.63亿元(+768.85%)。2024年Q1季 药 伍可心 S0630522120001 生 wkx@longone.com.cn 度实现营业收入7.36亿元(+38.40%),归母净利润0.98亿元(+90.95%)。公司2023年销 联系人 售费用率为 34.76%(+1.98pp),管理费用率10.66%(-8.49pp),财务费用率为 1.61%(- 物 付婷 5.78pp),研发费用率为 26.06%(- ...
业绩重回增长轨道 贝美纳快速放量+新产品贡献业绩增量
长城国瑞证券· 2024-04-22 12:00
2024年04月22日 证券研究报告/公司研究 化学制剂/化学制药/医药生物 贝达药业 300558.SZ 业绩重回增长轨道 基础数据: 贝美纳快速放量+新产品贡献业绩增量 截至2024年4月22日 当前股价 38.3元 事件:公司发布2023年年报及2024年一季报:2023年公司实现营收24.56 投资评级 买入 评级变动 维持 亿元,同比增长3.35%;归母净利润3.48亿元,同比增长139.33%;扣非 总股本 4.18亿股 归母净利润2.63亿元,同比增长768.85%。2024年一季度公司实现营收 流通股本 4.17亿股 7.36亿元,同比增长38.40%;归母净利润9,814.07万元,同比增长90.95%; 总市值 160.09亿元 流动市值 159.77亿元 扣非归母净利润8,956.28万元,同比增长390.39%。 相对市场表现: 事件点评: ◆利润端重回增长,管理及财务费用大幅下降。2023年公司实现营业收 入24.56亿元,已上市的五款药品作为主要收入来源、占总营收的 98.40%;扣非归母净利润为2.63亿元,同比增长768.85%,重回增长; 管理费用为2.62亿元,同比下降42 ...
贝福替尼有望快速放量,创新管线稳步推进
西南证券· 2024-04-22 10:00
[Table_StockInfo] 持有 2024年 04月 21日 (维持) 证券研究报告•2023年报及 2024年一季报点评 当前价:3 6.04元 贝达药业(300558) 医 药生物 目标价:— —元(6个月) 贝福替尼有望快速放量,创新管线稳步推进 投资要点 西南证券研究发展中心 [T ab业le绩_S总um结m:a公ry]司 发布 2023 年报和 2024 年一季报,2023 年实现营业收入 24.56亿元(+3.35%),归母净利润 3.48亿元(+139.33%),扣非后归母净利 [分Ta析bl师e_:Au杜th向or阳] 润 2.63 亿元(+768.85%)。2024 年一季度实现营业收入 7.36 亿元 执业证号:S1250520030002 (+38.40),归母净利润 0.98 亿元(+90.95%),扣非后归母净利润 0.9 亿元 电话:021-68416017 (+390.39%)。 邮箱:duxy@swsc.com.cn 贝福替尼有望快速放量,恩莎替尼一线 NDA 获 FDA 受理。2023年,赛美纳 [相Tab对le指_Q数u表ot现eP ic] 二线治疗适应症、一 ...
费用管控合理,多品种拉动增长
申万宏源· 2024-04-22 09:01
上 市 公 司 医药生物 2024年04月21日 贝达药业 (300558) 公 司 研 究 ——费用管控合理,多品种拉动增长 公 司 点 报告原因:有业绩公布需要点评 评 买入 投资要点: (维持) ⚫ 事件。公司发布2023年年报和2024年一季报,23年公司实现营业收入24.56亿元(同 比+3.35%),实现归母净利润3.48亿(同比+139.33%),实现扣非归母净利润2.63亿 证 市场数据: 2024年04月19日 (同比+768.65%)。2024年一季度,公司实现营业收入7.36亿(同比+38.40%),实 券 收盘价(元) 36.04 研 一年内最高/最低(元) 73.11/33.11 现归母净利润0.98亿(同比+90.95%),实现扣非归母净利润0.90亿(同比+390.39%), 究 市净率 2.7 埃克替尼受竞品影响持续下滑,新品上市放量进度低于此前预期,因此公司业绩低于预期。 报 息率(分红/股价) - 告 流通A股市值(百万元) 15034 ⚫ 产品收入结构更加多元化,管理费用和研发费用进一步下降。2023 年公司的营收由 5 款 上证指数/深证成指 3065.26/9279. ...
23FY及24Q1延续高增长,多点驱动布局肺癌
华安证券· 2024-04-22 04:00
贝达[Ta药ble业_S(tock 3N 0am 0e 5R 5p 8tT .y Spe Z] ) 公司研究/公司点评 23FY 及 24Q1 延续高增长,多点驱动布局肺癌 [T投 a资 ble评 _R级 a: nk买 ] 入(维持) 主要观点: 报告日期: 2024-04-21 ⚫[T 事ab件le_S1 ummary] [收Ta盘bl价e_(Ba元se)D ata] 36.04 2024年4月20日,贝达药业发布2023年年报,报告期内公司实现营 近12个月最高/最低(元) 73.04/33.11 业收入 24.56 亿元,同比+3.35%;归母净利润 3.48 亿元,同比 总股本(百万股) 418 +139.33%;扣非归母净利润2.63亿元,同比+768.85%。单季度来看, 流通股本(百万股) 417 公司2023Q4收入为4.13亿元,同比-42.20%;归母净利润为0.43亿 流通股比例(%) 99.73% 元,同比+1.70%;扣非归母净利润为0.22亿元,同比+167.24%。 总市值(亿元) 150.82 ⚫ 事件 2 流通市值(亿元) 150.34 2024年4月20日,贝达药业发布20 ...
业绩符合预期,新药上市和进医保驱动业绩增长
国联证券· 2024-04-21 15:30
证券研究报告 公 2024年04月21日 司 报 告 贝达药业(300558) │ 行 业: 医药生物/化学制药 公 投资评级: 增持(维持) 司 当前价格: 36.04元 年 业绩符合预期,新药上市和进医保驱动业绩增长 目标价格: 42.61元 报 点 事件: 评 基本数据 贝达药业公布2023年年报和2024年一季报。2023年实现收入24.56亿元 总股本/流通股本(百万股) 418.49/417.16 (同比+3.35%),实现归母净利3.48亿元(同比+139.33%),实现扣非归母 流通A股市值(百万元) 15,034.30 净利2.63亿元(同比+768.85%);2024年一季度实现收入7.36亿元(同比 每股净资产(元) 13.20 +38.40%),实现归母净利 0.98 亿元(同比+90.95%),实现扣非归母净利 资产负债率(%) 39.82 0.90亿元(同比+390.39%)。业绩符合预期。 一年内最高/最低(元) 73.11/33.11 ➢ 业绩符合预期,新药上市和进入医保驱动业绩增长 公司2023年以及2024年1季度均实现增长,我们认为主要是由于贝美纳 股价相对走势 的1线适 ...
贝达药业(300558) - 2023 Q4 - 年度财报
2024-04-19 11:03
Financial Performance - Revenue in 2023 increased by 3.35% to 2,456,196,486.62 yuan compared to 2022[10] - Net profit attributable to shareholders surged by 139.33% to 348,032,472.42 yuan in 2023[10] - Operating cash flow grew significantly by 198.05% to 914,227,977.50 yuan in 2023[10] - Basic earnings per share rose by 137.14% to 0.83 yuan in 2023[10] - Total assets increased by 15.64% to 9,146,908,395.53 yuan at the end of 2023[10] - Q2 2023 revenue was the highest at 782,259,420.96 yuan among all quarters[11] - Q3 2023 net profit attributable to shareholders reached 156,386,574.59 yuan, the highest quarterly figure[11] - Revenue for 2023 reached 24.56 billion yuan, a year-on-year increase of 3.35%[39] - Net profit attributable to shareholders was 348.03 million yuan, up 139.33% year-on-year[39] - Non-GAAP net profit was 262.85 million yuan, a significant increase of 768.85% year-on-year[39] - Operating cash flow surged to 914.23 million yuan, up 198.05% year-on-year[41] - Total revenue for 2023 reached 2,456,196,486.62 yuan, a year-on-year increase of 3.35%[56] - Pharmaceutical manufacturing accounted for 100% of total revenue, with drug sales contributing 98.40%[56] - Domestic sales accounted for 99.96% of total revenue, with a year-on-year increase of 3.32%[56] - Gross profit margin for pharmaceutical manufacturing was 83.53%, a decrease of 5.16% compared to the previous year[57] - Sales volume increased by 2.52% to 3,047,651 boxes, while production volume decreased by 15.71% to 3,806,830 boxes[58] - The top five customers accounted for 61.45% of total sales, with the largest customer contributing 31.62%[61] - The top five suppliers accounted for 42.23% of total procurement, with the largest supplier contributing 17.17%[62][63] - Sales expenses increased by 9.61% to RMB 853.89 million in 2023 compared to RMB 779.06 million in 2022[64] - Management expenses decreased by 42.49% to RMB 261.76 million in 2023 due to reduced equity incentive costs[64] - Financial expenses decreased by 77.45% to RMB 39.59 million in 2023 due to reduced interest expenses[64] - R&D expenses decreased by 8.54% to RMB 640.14 million in 2023 compared to RMB 699.90 million in 2022[64] - Operating cash flow increased by 198.05% to 914,227,977.50 yuan, driven by higher cash inflows from drug sales[68] - Investment cash flow net outflow increased by 13.68% to -1,505,452,905.04 yuan, mainly due to the purchase of long-term assets and equity investments[68] - Financing cash flow net inflow decreased by 35.40% to 608,193,350.56 yuan, despite a 79.00% increase in cash inflows from financing activities[68] - Net cash and cash equivalents increased by 134.12% to 20,712,054.82 yuan[68] - Non-operating income accounted for 19.12% of total profit, primarily from compensation payments[70] - Long-term loans increased by 11.56% to 1,816,000,000.00 yuan, reflecting new bank loans during the reporting period[71] - Intangible assets increased by 5.84% to 1,943,510,385.64 yuan, mainly due to the transfer of development costs for newly approved drugs[71] - Overseas assets accounted for 26.25% of the company's net assets, with Xcovery Holdings, Inc. being the largest contributor[72] - The fair value of other equity instrument investments increased by 41,845,298.27 yuan, reaching 1,006,597,002.32 yuan at the end of the period[73] - Total investment during the reporting period increased by 8.30% to 1,705,971,266.15 yuan[74] - The company invested a total of 1,116,240,904.06 yuan in significant equity investments during the reporting period, with a total investment loss of -21,721,933.08 yuan[75] - The company invested 716,490,862.42 yuan in Xcovery Holdings, Inc., holding a 98.44% stake, resulting in a loss of -19,696,491.56 yuan[75] - The company invested 249,750,000.00 yuan in Hangzhou Beicheng Venture Capital Partnership, holding a 49.95% stake, resulting in a loss of -2,025,441.52 yuan[75] - The company invested 150,000,041.64 yuan in Beijing Mabworks Biotech Co., Ltd., holding a 2.91% stake[75] - The company invested a total of 589,730,362.09 yuan in significant non-equity investments during the reporting period, with a cumulative actual investment of 1,958,290,885.25 yuan[76] - The DreamWorks Phase II project has a cumulative investment of 1,313,872,501.95 yuan, with a progress rate of 72.99%[76] - The Shengzhou Innovative Drug Industrialization Base project has a cumulative investment of 644,418,383.30 yuan, with a progress rate of 65.76%[76] - The company's securities investment in AGENUS resulted in a loss of -52,907,243.50 yuan, with an ending book value of 28,595,124.38 yuan[77] - The company invested 150,000,041.64 yuan in Beijing Mabworks Biotech Co., Ltd. through a private placement, holding 2,095,558 shares[78] - The company's total raised funds amounted to 1,001,999,913.43 yuan, with a net amount of 995,405,374.70 yuan, and a cumulative usage of 68,991.37 million yuan[79] - The company used up to 300 million yuan of idle raised funds to temporarily supplement working capital, with a usage period not exceeding 12 months, and the full amount was returned to the raised funds special account by December 9, 2023[80] - As of December 31, 2023, the balance of idle raised funds used to temporarily supplement working capital was 260 million yuan[80] - The new drug R&D and R&D equipment upgrade project had a total investment commitment of 742 million yuan, with 58.83% (436.51 million yuan) invested by the end of the reporting period[81] - The supplementary working capital project had a total investment commitment of 260 million yuan, with 100% (253.41 million yuan) invested by the end of the reporting period[81] - The CM082 combined with JS001 for mucosal melanoma treatment clinical phase III project was suspended due to insufficient clinical advantages and inability to gain commercial competitive advantage in the current market environment[81] - The company used 176.58 million yuan of raised funds to replace pre-invested self-raised funds in the fundraising projects and paid issuance costs[81] - As of December 31, 2023, the unused raised funds were stored in the company's raised funds special account, with a balance of 260 million yuan temporarily supplementing working capital[82] - BPI-16350 project received RMB 127.5057 million in funding for Phase III clinical trials targeting HR-positive/HER2-negative advanced breast cancer[83][84] - The investment progress for BPI-16350 reached 62.90% with RMB 80.2009 million cumulatively invested by the end of the reporting period[83] - Hydrochloric acid ensartinib capsule project received RMB 60 million for Phase III clinical trials targeting ALK-positive NSCLC postoperative adjuvant treatment[83][84] - The investment progress for hydrochloric acid ensartinib capsule project reached 21.49% with RMB 12.8927 million cumulatively invested by the end of the reporting period[83] - X-396 project funding was reduced as it completed Phase III clinical trials and received approval for market launch[84] - CM082 combined with JS001 project funding was reduced due to insufficient clinical advantages and lack of commercial competitiveness[84] - MIL60 project funding was reduced as it completed Phase III clinical trials and received approval for market launch[84] - Total adjusted funding for new drug R&D projects amounted to RMB 187.5057 million[83] - Xcovery Holdings, Inc., a subsidiary, reported a net loss of RMB 199.3499 million[85] Product Portfolio and R&D - The company's main products include "Kemena" (Icotinib Hydrochloride Tablets), "Beimena" (Ensartinib), "Beianting" (Bevacizumab Injection), "Saimena" (Befotertinib Mesylate Capsules), and "Fumena" (Vorolanib Tablets)[4] - The company's Beijing and Hangzhou R&D centers are subsidiaries focused on new drug development[4] - The company's main business is the development and production of anti-tumor drugs, including small molecule and large molecule drugs[4] - The company's products are mainly used for the treatment of non-small cell lung cancer (NSCLC) and other cancers[4] - The company has successfully commercialized five new drugs, including Kaimeina, Beimeina, and Saimeina, which have become new revenue growth drivers[22] - The company has established a strong position in the lung cancer treatment field, with Kaimeina being the first domestically developed small molecule lung cancer targeted drug in China[21] - The company has also achieved a breakthrough in the kidney cancer treatment field with the launch of Fumeina, the first domestically developed anti-angiogenic drug in China[21] - The company's R&D pipeline focuses on unmet clinical needs in the field of malignant tumor treatment, particularly lung cancer[21] - The company's strategy includes academic promotion and real-world research to meet the treatment needs of experts and patients[21] - The company aims to build differentiated product advantages and promote more products to achieve successful commercialization[21] - Kemena (Icotinib) achieved a median DFS of 47.0 months vs. 22.1 months in the chemotherapy group for II-IIIA stage NSCLC patients with EGFR mutations[25] - Kemena reduced the risk of disease recurrence by 77% in completely resected IB stage NSCLC patients compared to the observation group[25] - Kemena's 3-year DFS rate was 63.9% vs. 32.5% in the chemotherapy group for II-IIIA stage NSCLC patients[25] - Bemnax (Ensartinib) showed a median PFS of 41.5 months in the overall population and 47.1 months in the non-brain metastasis population for ALK-positive NSCLC[24] - Bemnax's new drug application for first-line treatment of ALK-positive NSCLC was accepted by the US FDA[24] - Saimena (Furmonertinib) achieved a median PFS of 22.1 months in first-line treatment and 16.6 months in second-line treatment for EGFR-mutated NSCLC[24] - Saimena's median OS in second-line treatment reached 31.5 months, with an ORR of 92.3% in patients with baseline brain metastases[24] - Fumena (Fruquintinib) combined with everolimus achieved a median PFS of 10 months and a median OS of 30.4 months in advanced RCC patients[24] - Kemena has been involved in over 100 clinical studies and published 259 SCI papers with a total impact factor of 1,086.97[25] - Kemena was included in the National Reimbursement Drug List (NRDL) for all its approved indications[25] - Envonalkib (Bemena) has achieved a median PFS of 41.5 months in the Asian population, with a 4-year OS rate of 75.7% in the baseline non-brain metastasis group[27] - Envonalkib (Bemena) demonstrated a median PFS of 23.9 months in patients with baseline brain metastasis[27] - Envonalkib (Bemena) showed a median OS of 42.8 months in patients with advanced crizotinib-resistant NSCLC[27] - Envonalkib (Bemena) has published 64 articles with a total impact factor of nearly 400 points[27] - Envonalkib (Bemena) has completed enrollment for Phase II-IIIB in postoperative adjuvant therapy trials in China[26] - Envonalkib (Bemena) has submitted a new drug application for first-line treatment to the US FDA in March 2024[26] - Bevacizumab (Beianting) demonstrated an ORR of 48.6% at 12 weeks, equivalent to Avastin[28] - Bevacizumab (Beianting) has published 3 SCI papers with a total impact factor of 24.23 points[29] - BPI-D0316 (Saimeina) is a novel third-generation EGFR-TKI with independent intellectual property rights[30] - Saimena (Befotertinib) achieved a median PFS of 22.1 months in the IBIO-103 study, significantly higher than the 13.8 months in the Icotinib group[31] - Saimena's median PFS for patients with baseline brain metastasis was 19.4 months, compared to 13.7 months in the Icotinib group[31] - Saimena has been included in the National Reimbursement Drug List and has published 5 SCI papers with a total impact factor of 116.66[31] - Fumena (Vorolanib) combined with Everolimus showed a median PFS of 10.0 months, significantly better than the 6.4 months in the Everolimus monotherapy group[33] - Fumena combined with Everolimus achieved an ORR of 24.8%, significantly higher than the 8.3% in the Everolimus monotherapy group[33] - Fumena has published 17 SCI papers with a total impact factor of 74.06 and has been presented at international conferences[33] - EYP-1901, a sustained-release formulation of Vorolanib, reduced injection frequency by 89% and 85% in the 2mg and 3mg dose groups, respectively[33] - 65% and 64% of patients in the EYP-1901 2mg and 3mg dose groups did not require anti-VEGF rescue therapy for six months[33] - The company has established a leading domestic R&D system with centers in Beijing and Hangzhou, focusing on unmet clinical needs[35] - The company adheres to GMP standards throughout the entire production process, ensuring stable product quality[37] - R&D investment in 2023 was 1.00 billion yuan, accounting for 40.80% of revenue[41] - Kaimeina (凯美纳) extended its product lifecycle with stable sales, supported by strong clinical data[40] - Beimeina (贝美纳) saw rapid sales growth after being included in the National Reimbursement Drug List (NRDL) in 2023[40] - New products Saimeina (赛美纳) and Fumeina (伏美纳) were approved and included in the NRDL, contributing to revenue growth[40] - The company has 5 marketed products, with 4 included in the NRDL, diversifying revenue sources[48] - Strategic collaborations with companies like TianGuangShi and EYPT enriched the R&D pipeline[45] - R&D investment in 2023 reached RMB 10,020.505 million, accounting for 40.80% of total revenue, driving pipeline growth and achieving milestones[49] - 5 products are now on the market, with 4 included in the National Reimbursement Drug List (NRDL)[49] - BPI-16350 Phase III clinical study completed patient enrollment in April 2023, showing a confirmed ORR of 60.5% with good safety[49] - 10 drug candidates/indications received clinical trial approvals in 2023, including TEAD inhibitor BPI-460372 approved for clinical studies in both China and the US[49] - CFT8919 exclusive rights in China secured with a $10 million upfront payment, and $25 million invested in C4T for 5,567,928 shares[51] - RMB 21 million invested in Hangzhou Guoshun Jianheng Venture Capital Partnership, with the company contributing RMB 4 million (19.05%)[51] - Production of all batches in 2023 achieved a 100% qualification rate, ensuring stable supply for commercial and clinical use[52] - BPI-442096, BPI-371153, BPI-361175, BPI-452080, BPI-460372, and BPI-21668 clinical trial drug supplies were delivered as planned[53] - Ensartinib (ALK inhibitor) NDA for NSCLC treatment accepted by the US FDA, currently under review[54] - Caimena and Baimena maintained in the NRDL, while Samena and Fumena were newly included in 2023[54] - The company's main products include Icotinib Hydrochloride Tablets, Ensartinib Hydrochloride Capsules, Befotertinib Mesylate Capsules, and Vorolanib Tablets, all of which are protected by patents until at least 2027[55] - The company has multiple R&D projects in Phase III clinical trials, including BPI-16350 and BPI-D0316, which are expected to contribute to future revenue growth[65] - The company decided to suspend the development of BPI-43487 and BPI-421286 due to insufficient clinical advantages[66] Corporate Governance and Shareholder Information - The company's profit distribution plan for 2023 is to distribute a cash dividend of 1.7 yuan per 10 shares (tax included) based on 418,485,885 shares[3] - The company's registered address was changed to No. 355 Xingzhong Road, Economic and Technological Development Zone, Linping District, Hangzhou, Zhejiang Province on December 12, 2023[6] - The company's stock code is 300558, and its legal representative is Ding Lieming[6] -