迈博药业-B2024年度报告

: 2181 2024 24581336120138147171178179181182184268269274 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands G79225300 183171712-1716 8318A 97927 Walkers Corporate Limited190 Elgin AvenueGeorge TownGrand Cayman KY1-9008Cayman Islands 50037 1 123 2181 www.mabpharm.cn CMAB009® CMAB008®CMAB009®CMAB007®196.3%PIC/SGMPCMAB008® CMAB009®FOLFIRIRAS/BRAFmCRCmCRCEGFRCMAB009® CMAB807CMAB015CMAB01740,000CDMOCDMO PIC/S 913 ✓CMAB009®CMAB009®EGFRS20240025FOLFIRIRAS/BRAFmCRCCMAB009PCTPCTPCT/CN2016/070024)CHO CMAB009®CMAB009®CMAB009®CMAB009®mCRCEGFRCMAB009®CMAB009® 50EGFR2%EGFRCMAB009®CMAB009®28CMAB009® ✓CMAB007®S2023003075mgS20230031150mgIgECMAB007®H112CMAB007®IIIIgECMAB007®CMAB007® CMAB007®CMAB007®CMAB007®GPOCMAB007®CMAB007®18CMAB007®2,125% ✓CMAB008®S2021002512)3)4)65)6CMAB008® CMAB008®1,000688136CMAB008®CMAB008®108%CMAB008®MIS-CCMAB008® CMAB008®CMAB008®CMAB008®GMPPIC/SGMPCMAB008® CMAB015CMAB015IIIICMAB807/CMAB807XIIICMAB017EGFRCMAB017CMAB022 203863 7,500GMPGMP40,000CDMO PIC/SGMP ®CMAB009 CMAB009®EGFRFOLFIRImCRCCMAB009PCTPCTPCT/CN2016/070024)CHO CMAB009® CMAB009®FOLFIRImCRCCMAB009®mCRCEGFRCMAB009®CMAB009® 50EGFR2%EGFRCMAB009®CMAB009®CMAB009® ®CMAB007 CMAB007®IgEIgECMAB007®IgEIgEIgECMAB007®4824CMAB007®CMAB007®CMAB007® CMAB007®S2023003075mgS20230031150mgIgENDACMAB007®H112CXSL230037775mgCXSL2300378150mgCMAB007®NDA CMAB007®CMAB007®CMAB007®CMAB007®CMAB007®GPOAB50CMAB007®18CMAB007®CMAB007®CMAB007®2,125% ®CMAB008 CMAB008®TNFS20210025 (i)(ii)(iii)(iv)6(v)(vi) CMAB008®CMAB008®CHOTNFTNFCMAB008®TNFTNFCMAB008®CMAB008® CMAB008®CMAB008®1,000(IBD) CMAB008® CMAB008®108%CMAB008®MIS-CCMAB008®GMPPIC/SGMPCMAB008® CMAB807/CMAB807XRANKLBG2(IgG2)RANKLCMAB807/CMAB807XRANKLRANKRANKLRANK RANKLRANKLRANKRANKCMAB807/CMAB807XRANKLRANK CMAB807/CMAB807XIIINDACMAB807/CMAB807XNDACMAB807/CMAB807X CMAB017EGFRCMAB017G1(IgG1)FcCMAB017CMAB017CMAB017CMAB017CMAB01724-72CMAB017I CMAB015secukinumabIgG117AIL-17A17(IL-17)IL-17ACMAB015IL-17ACMAB015IIIICMAB015NDA CMAB819CMAB819ICMAB819CMAB819 CMAB022®stelara®ustekinumab12IL-12)23IL-23)IL-12IL-23P40IL-12R1IL-12IL-23FDAUNITI-1UNITI-2IM-UNITITNFCMAB022 CMAB023TSLPIgG2-lambdaTEZSPIRE (Tezepelumab)TSLPTSLPTSLPCMAB023 CMAB016®Dupixent®dupilumabG4(IgG4)CMAB0164IL-4)IL-413IL-13)FDA(COPD)BOREASNOTUS52COPD30%34%52CMAB016 CMAB008CMAB007CMAB009CMAB807/CMAB807XNDAGMP G7930,000(i)3×1,500(ii)400(iii)100CMAB008CMAB007CMAB009GMPPIC/SGMP 100,746(i)7,50018,000(ii)1,000(iii)40,000 CMAB008®GMPPIC/SCMAB008GMPCMAB008 (i)(ii) GMPGMP PIC/S CMAB008CMAB007CMAB009CMAB807/CMAB807XCMAB015 87.2196.3%258.2CMAB009CMAB007CMAB008CMAB806 11.9225.7%38.8 75.2191.6%219.485.0% 3.6123.7%8.0 1.4318.3%5.7 123.239.0%75.2 104.75.5%110.4 9.610.2%10.6 209.438.9%127.9 19.4386.7%94.6 173.348.5%89.3 47.5245.618.5 59.3 288100,74633.550,835168.9180.0195.2 412,4084,124,080,000 91.2%8.8%80.2%19.8% 100%91.2%80.2% (1)(2) (1)(2) 1.11.20.8 ESGESG C2ESG (02181.HK) (www.hkexnews.hk)(www.mabpharm.cn) 1.ESG ESGESGESG 1.1ESG ESGESG ESGESGESGESGESGESGESG 1.2 ESGESG 1.3 ESGESG 2. 2.1 2.1.1 2.1.2 111 2.2 2.2.1 2.2.2 2.2.3 3. 3.1 3.1.1 GMP2 LIMS3EMS4BMS5 22616272%75,212 CMAB008®CMAB007®CMAB009®CMAB807/CMAB807X GMP4SCI21 3.1.2 3.2 3.2.1 EMA6 PIC/S7 EP8 USP9WHO10 PDA11 ISPE12CAPA13 GMP 5GMPPIC/SGMP GMP GMP1PDA TR90G79 GMPGMPGMP GMP PIC/S GMP12B11(GMP) 2865(SAR) (8000) 在臨床試驗方案中，規範藥物不良反應報告和監測的管理，及時上報所收集到的藥品質量及受試者不良反應事件 將SUSAR18快速報告給所有參加試驗的研究者、臨床試驗機構、倫理委員會、藥品監督管理部門和衛生健康主管部門 3141111®22®8®(SOP) CAPA400-102-1306CMAB007®8400 3CMAB007®2CMAB008®13100% 279CMAB009®®348 3.2.2 CROSMO 4. 4.1 4.1.1 BC 11 1,38620 4.1.2 ESGESGESG 4.2 CMAB009CMAB008 CMAB009CMAB008 5. 5.1 5.1.1 5.1.2 (ISSB)2 2RCP2.6NZE2RCP8.5STEPS 5.1.3 5.1.4 8,940.7634.62 5.2 EHS22 能源管理 水資源管理 排放物管理 ‧ 上線能源管理平台，逐步推進能源管理數字化‧ 推進設備節能優化，實現能耗強度負增長‧ 推進節能技改項目 ‧ 提高廢水、固體廢物回收利用率‧ 加強廢氣監測和治理‧ 減少廢棄物產生 ‧ 設立用水強度管理目標，逐步降低用水強度‧ 制定並嚴格執行水循環利用計劃‧ 加強水資源消耗及其異常情況的追蹤 5.3 5.3.1 SOP-ED-EQ-012G79 (COD) COD4(GB 8978-1996)(GB 18918-2002) 5.3.2 20 24 5.3.3 5.4 5.4.1 5.4.2 優化配液系統清洗程序，節約注射用水消耗 5.4.3 6. 6.1 6.1.1 31579100%60.95%41%20% 16.92% 6.1.2 6.2 6.2.1 SOP PIC/S GMP12B11GMP 1,8792625247,6051,5992,39812,79218180 6.2.2 6.3 EHS 23 6.4 6.4.1 6.4.2 7. 7.1 CMAB008®CMAB007®CMAB009® CMAB009®381131256206,199 3,000CMAB008®3,804,000591,816.81,208 1 388(2)5 36 3947 178180 RO 13.91C236119 1. •• 2. • 3. • 4. • 5. • 6. •• (1)(2)(3)155159 108112 3.133.13 33 33D2 24.4%5.5% 44.8%20.3% 5% 10 8.10 Sinomab 268 15 28 39,000257,0007,328 1811,332.81,333.8 25 XV(i)XV78(ii)352(iii)C3 (1)4,124,080,000(2)29 XVXV78352 336 (1)Asia Mabtech49.95%4.05%Asia Mabtech100%Asia MabtechAsia Pacific Immunotech VentureAsia Pacific Immunotech VentureXV167,025,000Asia Mabtech2,059,975,000(2)CDH PE18.00%CDH PECDH FundCDH FundCDH PECDH FundCDH VCDH VChina Diamond V80%ChinaDiamond VChina Diamond100%(3)FH InvestmentLink Best Capital LimitedLi