复宏汉霖2023中期报告

SHANGHAI HENLIUS BIOTECH, INC.上海復宏漢霖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：2696 中期報告2023 可負擔的創新值得信賴的品質 使命 持續創新，卓越運營；以優質生物藥，造福全球病患 願景 專注提供質高價優的生物藥，成為全球最受信賴的創新生物製藥公司 2 4 9 29 31 32 33 34 35 37 55 67 公司資料 Wenjie Zhang Wenjie Zhang12 Xingli Wang34 Wenjie Zhang2Xingli Wang34 5 Wenjie Zhang24 1.Wenjie Zhang20237 172.20237 1720238 283.Xingli Wang20238 284.20237 175.20231 1 公司資料 Wenjie Zhang 97927 18019 55 222330 288224 1617 H 183171712 1716 2696 www.henlius.com 1.20236302,500.520226301,289.41,211.193.9% 2.20236 30547.820226 30534.513.3 3.20236 30240.020226 30252.1492.1 運營摘要 ®Zercepac® 20232(FDA)Accord BioPharma Inc.(1)HER2(2)HER2(3)HER2(BLA) 20237Accord Healthcare Inc.HER2(New Drug Submission, NDS) ® 20231®(ES-SCLC)(NDA) 20233®(ES-SCLC)(MAA)(European Medicines Agency) ®2023CSCOCSCOCSCOCSCOCSCO9 ® 28 2023®PD-L1 VHH®Boston Oncology, LLCFBD Biologics Limited PT Kalbe Genexine Biologics •20231®(LS-SCLC)3202343 •®(ES-SCLC)39 •20232HLX04-OVEGF(wAMD)33 ® •20232HLX208BRAF V600E®(NSCLC)1b/2 •20234HLX26LAG-3®(NSCLC)2(IND)20238 •20236HLX26LAG-3®(mCRC)2 •20232HLX15CD381 •20232HLX07EGFR1b/21b/2 •20234HLX208BRAF V600EBRAF V600E(LCH)Erdheim-Chester(ECD)(CDE) •20237HLX04-OVEGF(wAMD)1/2 6 •20231HLX51OX40(IND)20233 •20234HLX13CTLA-4(IND)20236•20238HLX42EGFR1(IND) 運營摘要 •20238HLX43PD-L11(IND) •20238HLX17PD-1(IND)HLX17 (ADC)HanjugatorADCADC631449 48,00024,00024,00020237(BPOM)®(GMP)20238(FDA)®(Pre-License Inspection, PLI)(PFS) 管理層討論與分析 ®®®®63 5181®(ESCC)(NDA)(ES-SCLC)(MAA)®(BLA)20238(FDA)®(Pre-License Inspection, PLI) 1,3002019®®®®® ®Zercepac® ® ®®®®150mg60mgHER2HER2 ® ®®AccordPT KalbioGlobal MedikaLaboratorio ELEA Phoenix S.A.100®40® •20232(FDA)Accord BioPharma Inc.(1)HER2(2)HER2(3)HER2(BLA) •20234®420mgHertumab® •20237Accord Healthcare Inc.HER2(New Drug Submission, NDS) ®(MSI-H)(sqNSCLC)(ES-SCLC) PD-1®PD-1®291,50033,000®2023CSCOCSCOCSCOCSCOCSCO9 ®(MSI-H)(sqNSCLC)202220231®(ES-SCLC)(NDA)®(ES-SCLC)PD-1®20233®(ES-SCLC)(MAA)(European Medicines Agency) ®+5-FU(ESCC)(NDA)202323NatureMedicine82.9®(ESCC)2023CSCOCSCOI1A®(ESCC) ®® ®2019®19®® ®® ®®28 20234Boston Oncology, LLC®20238FBDBiologics LimitedPD-L1 VHHHCB30120238PT Kalbe Genexine Biologics® Chiome Bioscience, Inc.TROP2 ®(PD-1)HLX15CD38HLX07EGFRHLX208BRAF V600EHLX04-OVEGF(SCLC)(NSCLC)(mCRC)(LCH)Erdheim-Chester(ECD)(wAMD) 63 1 30 •20231®(LS-SCLC)3202343 •®(ES-SCLC)39•20232HLX04-OVEGF(wAMD)33 ® •20232HLX208BRAF V600E®(NSCLC)1b/2•20234HLX26LAG-3®(NSCLC)2(IND)20238•20236HLX26LAG-3®(mCRC)2 •20232HLX15CD381•20232HLX07EGFR1b/21b/2•20234HLX208BRAF V600EBRAF V600E(LCH)Erdheim-Chester(ECD)(CDE)•20237HLX04-OVEGF(wAMD)1/2 2IND (IND) •20231HLX51OX40(IND)20233•20234HLX13CTLA-4(IND)20236•20238HLX42EGFR1(IND)•20238HLX43PD-L11(IND)•20238HLX17PD-1(IND)HLX17 2023 (ADC)HanjugatorADCADC 631449 48,00024,00024,00096,0002026144,000 •GMP20237(BPOM)®GMP •24,000HLX04-OHLX11HLX14(PPQ)20238(FDA)®(Pre-License Inspection, PLI) •200201936,000(PFS)60,000415,000 2023 Biopharma •®®150mg60mg•®®®(ESCC)®•2023®®•®® 20238DDL100% ®® •®PD-L1(ESCC)(NDA)2023•®(nsNSCLC)(NDA)2023•®(ES-SCLC)(MAA)2024•®(ES-SCLC)(BLA)2024 ®®®®®®HER2HER2HER2(BLA)2023 2023 •HLX42EGFR1(IND)2023•HLX42EGFR1(IND)2023(FDA)•HLX43PD-L11(IND)2023•HLX43PD-L11(IND)2023(FDA)•HLX6018GARP/TGFβ11IND)2023 2023®(PPQ) ®® 2,500.593.9% 1 ®20208®1,238.7438.554.8%8.4 ®®20223®556.3 ®20231®44.9 ®®®®®254.110.9 ®®®®®®20.8 Zercepac®29.6 2 20186Accord®Zercepac®)Accord20207AccordZercepac®Zercepac®(EEA)20236 303.2 20199PT Kalbe Genexine Biologics®20236 3029.2 202010Essex Bio-Investment LimitedHLX04-OVEGF20236 3057.6 20226Organon LLCHLX11HER2IIHLX14RANKL2023630206.6 3 20222IND20236301.0 20229CMC20236 306.3 20221120236 3030.3 721.62022630416.0 1,778.82022630795.0 (1)(2) 26.8 673.82022630827.4153.6IND 163.72022630160.52.0%(1)(2) 783.0®®®® 12.4(1)5.7(2)6.5 20236 304.0 2022630252.1492.120236 30240.0 20236 30759.220236 302,616.9632.27.0120.0 2023630802.0864.7165.825.2 20236304,954.5596.31,166.0434.22,758.0 20236 30 20221231757.32023630802.0 2023630202212 31864.7455.5 20236 303,688.5 202363066.9% 2023630202212 3120171 116 20236 30802.1194.77.0 (1)(2)(3)100% 25.4 20236 30 20236 30340.0 20236 30 20236 30 2023630 1 2020106450202332023(mAb)(mAb) 2 ®®®®® 3 20236 30 獨立審閱報告 Ernst & Young27/F, One Taikoo Place,979 King’s RoadQuarry Bay, Hong Kong 315420236 30343434 2410 1420199 25202363020236 3025,202,000202212312023331 202363020236 3025,202,00020236 30202363020236 30 34 20238 25 (i)793,2937,306,00017,627,000 (ii)2,285,000302,00038,0002,00020236 30 2,780,72825,611,000 (ii)6,409,000809,0002,057,0006,00020226 30 中期簡明綜合現金流量表 20236 30 2023年6月30日中期簡明綜合財務資料附註 1. 222330 ••• 20199 25 2. 2.1. 202363034202212 31 20236 302,337,538,000 2.2. 202212 31 171717 179 1281212 2. 2.2. (a)12202311 (b)8202311 (c)1212202211202211 (d)1220231120231231 中期簡明綜合財務資料附註 2023年6月30日 3. (A) 4. 5. 6. 中期簡明綜合財務資料附註 2023年6月