康方生物2024 中期报告

目 錄 2 3 6 8 9 23 64 65 67 69 70 72 ACECMCGMPTetrabodyCMC 5010III412NMPA12I/II7first-in-classbest-in-class 0.00001 sNDA SUMMITSummit Therapeutics Inc.NASDAQ: SMMT WANG LLC XIA LLC % 執行董事 97927 20246302024630 非執行董事 2024630 Cooley HK 獨立非執行董事 Campbells TAN Bo TAN Bo Floor 4, Willow HouseCricket SquareGrand Cayman KY1–9010Cayman Islands 6528437 33191901 Campbells Corporate Services LimitedFloor 4, Willow HouseCricket SquareGrand Cayman KY1–9010Cayman Islands 183171712–1716 9926 www.akesobio.com 2020424 1.收入 20246 301,024.720236 303,676.92024630939.42023630757.923.96%202463085.320236302,919.0 2.毛利 2024630943.220236303,599.72024630857.92023630680.726.03% 3.期內盈利╱虧損 2024630249.320236302,489.5 939.4757.923.96%®PD-1/CTLA-4®PD-1/VEGF20245 202463SUMMIT80.0 開坦尼®（卡度尼利，PD-1/CTLA-4） 銷售表現持續強勁 ®705.7605.816.50%® 新一線適應症拓展 •20241G/GEJsNDANMPA20244III2024(AACR)2024CSCO2024CSCOPD-L1PD-L1 •20244sNDANMPA20247IIIOS 拓寬適應症，高效推進臨床 III •PD-L1NSCLCIII•III•AK109VEGFR-2PD-(L)1G/GEJIII20246II2024 ASCO•(TACE)(uHCC)III20241II2024(ASCOGI) 1620 依達方®（依沃西，PD-1/VEGF） 重塑EGFR-TKI耐藥後治療新格局 2024524NMPA®EGFR-TKIEGFRNSCLC20246IIIAK112-301/HARMONi-A2024 ASCO(JAMA)2024CSCOIV(2024) ®EGFR-TKINSCLC®103 對比帕博利珠獲決定性勝出陽性結果 20245PD-L1NSCLCIIIAK112-303/HARMONi-2PFSIII20247CDEsNDA NSCLCIIIAK112-306 IIIAK117CD47PD-L1IIIIII1720(IO) 發揮基石藥物的全球價值 SUMMITEGFR-TKIEGFRNSCLCIII(HARMONi)NSCLCIIIHARMONi-3202463SUMMITSUMMIT 管理層討論及分析 安尼可®（派安普利，PD-1） 2024430NMPA®(NPC)®NPCsNDANMPA 腫瘤領域其他產品 普絡西（AK109，VEGFR-2）國內III期臨床試驗首例受試者入組 •PD-(L)1G/GEJIII20246II2024 ASCO 萊法利（AK117，CD47）於海外、國內的多項臨床試驗進展順利 •AK117(MDS)IIAK117AK129PD-1/LAG-3ICDE•AK117PD-L1III 代謝及自免領域 2款產品NDA處於審評階段 •(HeFH)AK102PCSK9AK101IL-12/IL-23NDA 2款產品處於關鍵III期臨床試驗階段 •AK111IL-172III •AK120IL-4RIII ADCmRNA 臨床前候選產品遞交IND申請 •7AK137 (CD73/LAG-3)CDEIND•ADCAK138D1 (HER3 ADC)CDEIND•AK135 (IL-1RAP)CDEIND 產品管線臨床開發計劃 202463050227first-in-classbest-in-class ®PD-1/CTLA-4®PD-1/VEGF®PD-1AK117CD47AK119CD73AK109VEGFR-2AK127(TIGIT)AK115(NGF)AK129 PD-1/LAG-3AK130TIGIT/TGF-AK131PD-1/CD73AK132Claudin18.2/CD47AK135 (IL-1RAP)AK137 CD73/LAG-3AK138D1(HER3 ADC) AK102PCSK9NDA20236AK101IL-12/IL-23NDA20238AK111IL-17AK120IL-4R 管理層討論及分析 上市規則第18A.08(3)條規定的警示聲明：®®®AK117CD47AK109VEGFR2AK119CD73AK127(TIGIT)AK115(NGF)AK129 PD-1/LAG-3AK130TIGIT/TGF-AK131PD-1/CD73AK132Claudin18.2/CD47AK135IL-1RAPAK137CD73/LAG-3AK138D1(HER3 ADC)AK102PCSK9AK101IL-12/IL-23AK111IL-17AK120IL-4R 20246 302,815 202463054,000GMPFDAEMANMPAGMP •100,00040,000 •36,000 •3,500 (IO)ADC PD-1/CTLA-41620 PD-1/VEGFIIIIO1720SUMMIT AK129PD-1/LAG-3AK130TIGIT/TGF-AK131PD-1/CD73AK132Claudin18.2/CD47AK137CD73/LAG-35 AK102,PCSK9AK101,IL-12/IL-232AK111IL-17AK120IL-4RIII ADCAK138D1(HER3 ADC)INDADCmRNA 1.產品收入 2024630939.42023630757.923.96%®PD-1/CTLA-420245®PD-1/VEGF 2.銷售成本 202463081.6202363077.2®PD-1/CTLA-4®PD-1/VEGF 3.毛利 2024630943.220236303,599.72024630857.92023630680.726.03% 4.其他收入及收益淨額 2024630211.82023630380.1 5.研發開支 2024630594.42023630574.7CROAK109VEGFR-2IIIAK117CD472NDAIII (i)CRO(ii)(iii)(iv) * * 6.銷售及營銷開支 2024630516.02023630442.2(i)(ii)(iii) 7.行政開支 20246 3099.720236 30100.4 8.財務成本 202463046.2202363038.4 9.期內盈利╱虧損 2024630249.320236302,489.5 10.流動資產、資金來源及借款 2024 20246306,746.55,693.61,052.9 202312314,894.4799.220246305,693.6 20246301,409.7399.0724.1272.6 20246303,302.32.80%4.35% 11.資產抵押 6301,301.2 12.主要財務比率 (1)(2)100% 13.重大投資 2024630 20康方生物科技（開曼）有限公司|2024 14.重大收購及出售事項 202428買方賣方康融東方267.435%收購事項202429202434 2024630 15.或然負債 2024630 16.資本承擔 2024630778.520231231770.0 17.外匯風險 2024630 2024630 18.僱員及薪酬 20246302,815 2024630539.22023630408.0 2019829D.— 1.2024630202465202466 20211262021202112720212024630202465202466 20226282022612024630202465202466 2023630 C.2.1 C.2.1 1.2022年配售所得款項淨額用途 202271524,000,0002022782022年配售協議24.272022年配售20222.85% 24.27(i)202226.107.0%(ii)2022202225.675.5% 24.032022576.6520246302022 202220227820227152024630202220227820246302022 2.2024年配售所得款項淨額用途 202432824824,800,00020243212024年配售協議47.652024年配售20242.86%2024 47.65(i)202450.706.02%(ii)2024202451.136.81%202447.6020241,180.48 47.1820241,170.1820246302024 202420243212024328202463020242024321 989.120251231 20243282024202420243212024328 2024630 TAN Bo2410 20246 30 2012420122017220181120202471 202213.51B(1) 13.2013.2113.22 2024630XV(a)XV78(b)352(c) 於股份及相關股份的權益 (1)L(2)2024630865,857,176(3)XIA LLCXIA LLC(4)(5)Aquae Hyperion LimitedESOPESOPAquae Hyperion LimitedZedraTrust Company (Cayman) LimitedESOPAquaeHyperion LimitedAquae Hyperion Limited(6)(7)LI LLCLI LLC(8)(9)WANG LLCWANG LLC(10)(11)Waterband LimitedWoodband Limited.WaterbandLimitedWoodband TrustWoodband TrustWaterband Limited 2024630XVXV78(a)(b)352(c) 33620246 305% (1)L(2)2024630865,857,176(3)Waterband Limited33,258,065Woodband LimitedWoodbandLimitedWoodband TrustWoodbandTrustCantrust (Far East) LimitedNineSunsHolding Limited14,406,217Fourxi LimitedFourxiLimitedFourxi TrustFourxiTrustCantrust(Far East) LimitedCantrust (Far Eas