| 1 | Enhertu (DS-8201) | trastuzumab deruxtecan | Daiichi Sankyo | Japan | HER2 | DXd (topoisomerase I inhibitor) | Approved (FDA first approval Dec 2019; also NMPA etc.) | HER2+ / HER2-low breast cancer and others; newest: HER2+ early breast cancer (neoadjuvant DB-11, adjuvant DB-05) | NCT04622319 (DESTINY-Breast05); NCT05113251 (DESTINY-Breast11) | AstraZeneca (global co-development/commercialisation; Daiichi keeps Japan) | 2019-03 | NMPA approved adjuvant HER2+ early BC (DB-05), 9th China indication; FDA approved DB-05 + DB-11 early-BC indications on 2026-05-15 | 2026-09-29 | news.10jqka.com.cn www.astrazeneca.com www.chemexpress.com | 2026-10-09 |
| 2 | Datroway (DS-1062) | datopotamab deruxtecan | Daiichi Sankyo | Japan | TROP2 | DXd (topoisomerase I inhibitor) | Approved (FDA first approval Jan 2025) | Breast cancer, NSCLC; newest: 1L metastatic TNBC not candidates for PD-(L)1 | NCT05374512 (TROPION-Breast02) | AstraZeneca (Daiichi keeps Japan) | 2020-07 | US approval in 1L TNBC (TROPION-Breast02) | 2026-05-26 | www.lse.co.uk clinicaltrials.gov www.chemexpress.com | 2026-05-26 |
| 3 | Padcev (ASG-22ME) [co-originated] | enfortumab vedotin | Astellas Pharma (Japan) co-developed with Seagen (US, now Pfizer) | Japan (co-originated with US company) | Nectin-4 | MMAE (tubulin inhibitor) | Approved (FDA first approval Dec 2019) | Urothelial cancer; newest: perioperative MIBC with pembrolizumab regardless of cisplatin eligibility | NCT04700124 (EV-304); NCT04223856 (EV-302) | Co-owned Astellas & Pfizer (Seagen acquired by Pfizer 2023-12-14) - not a license-out | | FDA approved Padcev + Keytruda neoadjuvant/adjuvant MIBC regardless of cisplatin eligibility (EV-304) | 2026-07-13 | newsroom.astellas.com www.chemexpress.com | 2026-07-13 |
| 4 | Aidixi (RC48) | disitamab vedotin | RemeGen | China | HER2 | MMAE (tubulin inhibitor) | Approved (NMPA, first approval Jun 2021) | HER2+ gastric cancer (first); newest: 1L HER2-expressing urothelial carcinoma with toripalimab | NCT05302284 (RC48-C016) | Seagen, now Pfizer (worldwide ex-RemeGen territory; RemeGen keeps Asia excl. Japan & Singapore) | 2021-08-09 | NMPA approved DV + toripalimab 1L HER2-expressing la/mUC (RC48-C016: PFS 13.1 vs 6.5 mo; OS 31.5 vs 16.9 mo) | 2026-05-22 | news.qq.com www.cancernetwork.com www.businesswire.com | 2026-05-22 |
| 5 | Jiatailai (SKB264 / MK-2870) | sacituzumab tirumotecan | Sichuan Kelun-Biotech | China | TROP2 | KL610023 (topoisomerase I inhibitor) | Approved (NMPA, first approval Nov 2024; 4 China approvals in breast cancer & NSCLC) | Breast cancer; NSCLC (China). US BLA (endometrial) under priority review | NCT06132958 (TroFuse-005) | Merck & Co./MSD (ex-Greater China) | 2022 (reported 2022-05-19) | TroFuse-005 Ph3 (endometrial) OS 19.0 vs 12.1 mo published in Lancet/ESMO 2026; FDA BLA accepted, PDUFA 2027-06-15 | 2026-10-26 | www.biopharminternational.com gxpnews.net www.chemexpress.com | 2026-10-26 |
| 6 | Aiweida (SHR-A1811) | trastuzumab rezetecan | Jiangsu Hengrui Pharmaceuticals | China | HER2 | SHR9265 (topoisomerase I inhibitor) | Approved (NMPA, first approval May 2025; 3 China indications) | HER2-mutant NSCLC (first); HER2+ breast cancer; HER2+ colorectal cancer (3rd, 2026-08) | NCT06057610; NCT06123494; SHR-A1811-III-309 (HORIZON CRC01) | Glenmark (emerging markets only; excludes Greater China, US, Canada, Europe, Japan, Russia/CIS) | 2025-09-24 | NMPA approved 3rd indication HER2+ CRC; HER2-low BC sNDA accepted with priority review 2026-07-08 | 2026-08-06 | static.cninfo.com.cn news.10jqka.com.cn www.theweek.in | 2026-08-06 |
| 7 | Shutailai (A166) | trastuzumab botidotin | Sichuan Kelun-Biotech | China | HER2 | Duostatin-5 (tubulin inhibitor; MMAF-class) | Approved (NMPA) | Unresectable/metastatic HER2+ breast cancer after >=1 prior therapy | NCT06968585 (Ph3 vs T-DM1) | | | NMPA marketing approval | 2025-10-17 | www.thepharmaletter.com www.chemexpress.com clinicaltrials.gov | 2025-10-17 |
| 8 | Meiyouheng (MRG003) | becotatug vedotin | Lepu Biopharma / Shanghai Miracogen | China | EGFR | MMAE (tubulin inhibitor) | Approved (NMPA) | R/M nasopharyngeal carcinoma after >=2 lines chemo and PD-(L)1 | NCT05751512 (Ph3 SCCHN, ongoing); NCT06976190 (Ph3 NPC combo) | | | NMPA approval, first approved EGFR ADC (pivotal Ph2: ORR 30.2% vs 11.5%) | 2025-10-30 | global.pharmcube.com www.chemexpress.com | 2025-11-04 |
| 9 | Yizekang (BL-B01D1 / BMS-986507) | izalontamab brengitecan | Sichuan Baili Pharmaceutical (Biokin) / SystImmune | China | EGFR x HER3 (bispecific) | Ed-04 (topoisomerase I inhibitor) | Approved (NMPA conditional; first approved bispecific ADC) | R/M nasopharyngeal carcinoma (2026-06-22); 2L R/M ESCC (2026-07-17) | NCT06118333 (NPC Ph3); NCT06304974 (ESCC Ph3); NCT07100080 (BMS global Ph3) | Bristol Myers Squibb (ex-mainland China) | 2023-12 (announced 2023-12-11/12; $800M upfront) | NMPA approved 2nd indication (ESCC) 25 days after NPC approval | 2026-07-17 | www.biochempeg.com www.biopharminternational.com www.biopharminternational.com | 2026-08-20 |
| 10 | DB-1303 / BNT323 | trastuzumab pamirtecan | Duality Biotherapeutics (DualityBio) | China | HER2 | P1003 / pamirtecan (topoisomerase I inhibitor) | Phase 3 complete - BLA under NMPA review | 2L HER2+ unresectable/metastatic breast cancer | NCT06265428 (DB-1303-O-3001); NCT06018337 (DYNASTY-Breast02); NCT06340568 (global Ph3 endometrial) | BioNTech (ex-mainland China, HK, Macau) | 2023-04-03 | NMPA accepted BLA (Ph3 vs T-DM1 met PFS) | 2026-04-09 | www.onclive.com www.biontech.com | 2026-04-09 |
| 11 | IBI343 / TAK-921 | arcotatug tavatecan | Innovent Biologics | China | CLDN18.2 | Exatecan (topoisomerase I inhibitor) | Phase 3 complete - NDA under NMPA priority review | CLDN18.2+ gastric/GEJ adenocarcinoma after >=2 prior lines | NCT06238843 (G-HOPE-001, China/Japan); NCT07066098 (Ph3 pancreatic) | Takeda (ex-Greater China) | 2025-10-21 | Ph3 met PFS at interim; NMPA accepted NDA with priority review (world's first CLDN18.2 ADC filing) | 2026-06-04 | www.fiercebiotech.com www.takeda.com www.chemexpress.com | 2026-06-30 |
| 12 | LM-302 (TPX-4589) | tecotabart vedotin | LaNova Medicines (wholly owned by Sino Biopharmaceutical) | China | CLDN18.2 | MMAE (tubulin inhibitor) | Phase 3 complete (interim) - NDA under NMPA priority review | CLDN18.2+ gastric/GEJ adenocarcinoma after >=2 prior lines | NCT06351020 (Ph3 3L+); NCT07385703 (Ph3 1L combo) | None currently (Turning Point/BMS license of May 2022 terminated by BMS Oct 2024) | 2022-05 (terminated 2024-10) | NMPA accepted NDA (priority review); full Ph3 data expected early 2027 | 2026-06-23 | www.zhitongcaijing.com www.apexonco.com www.chemexpress.com | 2026-06-23 |
| 13 | DP303c | trastuzumab envedotin | CSPC Pharmaceutical Group | China | HER2 | MMAE (tubulin inhibitor; DAR ~2) | Phase 3 complete - NDA under NMPA review | Unresectable/metastatic HER2+ breast cancer after >=1 anti-HER2 therapy | NCT06313086 (Ph3 vs T-DM1) | | | NMPA accepted NDA (Ph3 PFS superior to T-DM1) | 2026-07-17 | doc.irasia.com db.antibodysociety.org clinicaltrials.gov | 2026-07-17 |
| 14 | HS-20093 / GSK5764227 | risvutatug rezetecan | Hansoh Pharmaceutical | China | B7-H3 | Topoisomerase I inhibitor | Phase 3 complete - BLA under NMPA review | SCLC progressed after platinum chemotherapy | NCT06498479 (ARTEMIS-008); NCT06526624; NCT06935409 | GSK (ex-mainland China, HK, Macau, Taiwan) | 2023-12 | NMPA accepted BLA; ARTEMIS-008 OS 18.5 vs 10.3 mo (HR 0.46) at WCLC 2026 | 2026-09-02 | www1.hkexnews.hk ascopost.com www.biospace.com db.antibodysociety.org | 2026-09-16 |
| 15 | YL201 | tambotatug pelitecan | MediLink Therapeutics | China | B7-H3 | Topoisomerase I inhibitor (TMALIN platform, DAR 8) | Phase 3 complete - NDA accepted by China CDE | Relapsed SCLC after 1 prior platinum line | NCT06612151 (TAISHAN-302); NCT06629597 (TAISHAN-301 NPC); NCT07739758; NCT07487896 | Roche (worldwide ex-mainland China, HK, Macau) | 2026-01 | TAISHAN-302 Ph3: OS 13.3 vs 9.4 mo (HR 0.46), WCLC 2026 + NEJM; China NDA accepted; Roche to start global Ph3 | 2026-09-13 | www.roche.com ascopost.com | 2026-09-13 |
| 16 | CMG901 / AZD0901 | sonesitatug vedotin | KYM Biosciences (JV: Keymed Biosciences 70% / Lepu Biopharma 30%) | China | CLDN18.2 | MMAE (per INN suffix -vedotin) | Phase 3 (positive topline) | 2L+ CLDN18.2+ gastric/GEJ/esophageal adenocarcinoma | NCT06346392 (CLARITY-Gastric01); NCT07431281 | AstraZeneca (global incl. China) | 2023-02-23 | CLARITY-Gastric01 global Ph3 positive: OS benefit (dual primary OS in 3L+ met; PFS not significant) | 2026-07-28 | www1.hkexnews.hk www.pharmafocusasia.com clinicaltrials.gov | 2026-07-28 |
| 17 | SYS6010 | | CSPC Pharmaceutical Group (CSPC Megalith) | China | EGFR | Topoisomerase I inhibitor | Phase 3 (positive topline) | EGFR-mutant advanced NSCLC after EGFR-TKI | NCT06927986 (SYNSTAR-01); 8 further Ph3 on CT.gov | | | SYNSTAR-01 Ph3 met PFS vs platinum chemo; OS trend positive | 2026-08-26 | filingreader.com clinicaltrials.gov | 2026-08-26 |
| 18 | DS-7300 / MK-2400 (I-DXd) | ifinatamab deruxtecan | Daiichi Sankyo | Japan | B7-H3 | DXd (topoisomerase I inhibitor) | Phase 3 | Relapsed ES-SCLC (IDeate-Lung02); also ESCC, mCRPC | NCT06203210 (IDeate-Lung02); NCT06644781; NCT06925737 | Merck & Co./MSD (global co-development; Daiichi keeps Japan) | 2023-10 | US accelerated-approval BLA (Ph2 IDeate-Lung01) voluntarily withdrawn; filing now depends on Ph3 IDeate-Lung02 | 2026-09-25 | www.merck.com | 2026-09-25 |
| 19 | U3-1402 / MK-1022 (HER3-DXd) | patritumab deruxtecan | Daiichi Sankyo | Japan | HER3 | DXd (topoisomerase I inhibitor) | Phase 3 | HR+/HER2- metastatic breast cancer (HERTHENA-Breast04); EGFRm NSCLC (HERTHENA-Lung02, OS not significant) | NCT07060807 (HERTHENA-Breast04); NCT05338970 (HERTHENA-Lung02) | Merck & Co./MSD (Daiichi keeps Japan) | 2023-10 | HERTHENA-Breast04 Ph3 enrolling (started 2025-07-21); US NSCLC BLA withdrawn 2025-05 | 2026-06-04 | www.onclive.com www.indianpharmapost.com | 2026-06-04 |
| 20 | DS-6000 / MK-5909 (R-DXd) | raludotatug deruxtecan | Daiichi Sankyo | Japan | CDH6 | DXd (topoisomerase I inhibitor) | Phase 3 (Ph2/3) | Platinum-resistant ovarian cancer; 1L/2L maintenance ovarian (new Ph3s) | NCT06161025 (REJOICE-Ovarian01); NCT07776691; NCT07743164; NCT07791732 | Merck & Co./MSD (Daiichi keeps Japan) | 2023-10 | New Merck/Daiichi Ph3 trials in ovarian maintenance started Sep-Oct 2026 (CT.gov); Ph2 part ORR 50.5% (ESMO 2025) | 2026-10-07 | www.merck.com clinicaltrials.gov | 2026-10-07 |
| 21 | DB-1311 / BNT324 | | Duality Biotherapeutics (DualityBio) | China | B7-H3 | Topoisomerase I inhibitor (DAR 6) | Phase 3 (global) | Metastatic castration-resistant prostate cancer vs docetaxel | NCT07365995 | BioNTech (ex-mainland China, HK, Macau; Duality US co-development option) | 2023-04-03 | Global Ph3 in mCRPC started (CT.gov start 2026-04-22) | 2026-04-22 | www.fiercebiotech.com clinicaltrials.gov www.biontech.com | 2026-04-22 |
| 22 | ZL-1310 | zocilurtatug pelitecan | Zai Lab (built on TMALIN platform) | China | DLL3 | Camptothecin derivative (topoisomerase I inhibitor) | Phase 3 (global) | 2L+ ES-SCLC (DLLEVATE) | NCT07218146 (DLLEVATE); NCT07796100 (1L Ph3, not yet recruiting) | Zai Lab retains global rights (Amgen = combination-trial collaborator only) | | DLLEVATE on track, enrollment complete expected 1H27; potential US accelerated filing 2027 | 2026-08-06 | www.biospace.com www.businesswire.com clinicaltrials.gov | 2026-08-06 |
| 23 | HLX43 | | Shanghai Henlius Biotech | China | PD-L1 | Topoisomerase I inhibitor (linker in-licensed) | Phase 3 (global Ph2/3) | Previously treated advanced/metastatic squamous NSCLC vs docetaxel | NCT07459751 | | | First patient dosed in global Ph2/3 (HLX43 +/- HLX07) | 2026-05-28 | www.hkexnews.hk clinicaltrials.gov | 2026-05-28 |
| 24 | BL-M07D1 (T-Bren) | | Sichuan Baili Pharmaceutical (Biokin) / SystImmune | China | HER2 | Ed-04 (topoisomerase I inhibitor) | Phase 3 (9 Ph3 trials) | HER2+ mBC vs T-DM1 (most advanced); also HER2-low BC, NSCLC, BTC, CRC, PROC | NCT06316531; NCT06957886; NCT06830889; NCT06891833; NCT07178795; NCT07545460 | | | 9th Ph3 started (HER2-expressing PROC); CDE BTDs in HER2+ GC and BTC | 2026-09-30 | pdf.dfcfw.com oncodaily.com clinicaltrials.gov | 2026-09-30 |
| 25 | LCB14 / FS-1502 / IKS014 | caxmotabart entudotin | LegoChem Biosciences (LigaChem) | South Korea | HER2 | MMAF (tubulin inhibitor; site-specific, DAR 2) | Phase 3 (China, by Fosun) | HER2+ mBC vs T-DM1 | NCT05755048 (Fosun Ph3); NCT05872295 (Iksuda Ph1) | Iksuda Therapeutics (worldwide ex-Greater China & Korea); Fosun Pharma holds Greater China | 2022-01-10 (Iksuda) | Ligachem R&D Day: Fosun Ph3 ongoing in China; IKS014 global Ph1 RP2D 105 mg/m2, ORR 35-40% | 2026-07-08 | biz.newdaily.co.kr db.antibodysociety.org www.businesswire.com | 2026-07-08 |
| 26 | MRG002 | | Lepu Biopharma / Shanghai Miracogen | China | HER2 | MMAE (tubulin inhibitor) | Phase 3 | HER2+ la/m urothelial cancer (also HER2+ BC Ph3, status unknown) | NCT05754853; NCT04924699 | | | Ph3 in HER2+ UC registered as recruiting (no newer verified event found) | 2023-04-13 | db.antibodysociety.org clinicaltrials.gov | 2023-04-13 |
| 27 | 9MW2821 | bulumtatug fuvedotin | Mabwell (Shanghai) Bioscience | China | Nectin-4 | MMAE (tubulin inhibitor) | Phase 3 (4 Ph3 trials) | 2L+ urothelial carcinoma (enrollment complete); cervical; 1L UC + toripalimab; TNBC | NCT06196736; NCT06592326; NCT06692166; NCT07556848 | | | 4 Ph3 ongoing; UC/CC interim analyses planned 2H26, then pre-NDA with NMPA | 2026-08-30 | www1.hkexnews.hk db.antibodysociety.org www.biospace.com | 2026-08-30 |
| 28 | JSKN003 | | Alphamab Oncology | China | HER2 (biparatopic) | Topoisomerase I inhibitor | Phase 3 (4 Ph3 trials) | HER2-low mBC; PROC; HER2+ mBC vs T-DM1; HER2+ CRC | NCT06079983; NCT06751485; NCT06846437; NCT07384377 | | | 4th Ph3 (HER2+ CRC) first patient dosed Feb 2026; FDA BTD in HER2-expressing PROC (Dec 2025) | 2026-03-25 | www1.hkexnews.hk www.pharmafocusasia.com | 2026-03-25 |
| 29 | SHR-A1921 | tizetatug rezetecan | Jiangsu Hengrui Pharmaceuticals | China | TROP2 | SHR9265 / rezetecan (topoisomerase I inhibitor) | Phase 3 | Platinum-resistant recurrent epithelial ovarian cancer | NCT06394492; NCT06211023 | | | Ph3 in PROC recruiting (CT.gov) | 2024-05-10 | db.antibodysociety.org clinicaltrials.gov | 2024-05-10 |
| 30 | HS-20089 / GSK5733584 | | Hansoh Pharmaceutical | China | B7-H4 | Topoisomerase inhibitor | Phase 3 | Platinum-resistant recurrent epithelial ovarian cancer; new Ph3 in platinum-sensitive OC | NCT06855069; NCT07821606 | GSK (ex-mainland China, HK, Macau, Taiwan) | 2023-10-20 | New Ph3 (with bevacizumab, PSOC) registered, start 2026-11-01 | 2026-11-01 | www.gsk.com clinicaltrials.gov | 2026-11-01 |
| 31 | TQB2102 | rolditamig deuderuxtecan (name per press; INN status not confirmed) | Chia Tai Tianqing (Sino Biopharmaceutical) | China | HER2 (biparatopic) | Topoisomerase I inhibitor | Phase 3 (5 Ph3 trials) | HER2-low mBC; HER2+ mBC vs T-DM1; neoadjuvant HER2+ BC | NCT06561607; NCT07008976; NCT07003074; NCT07043725 | Cipla (India, South Africa + 5 emerging markets only) | 2026-08-31 | Cipla license for emerging markets | 2026-08-31 | www.outsourcedpharma.com db.antibodysociety.org | 2026-08-31 |
| 32 | SHR-A1904 | | Jiangsu Hengrui Pharmaceuticals | China | CLDN18.2 | Topoisomerase I inhibitor | Phase 3 | 2L CLDN18.2+ advanced gastric/GEJ cancer | NCT06649292 | Merck KGaA (option for ex-China license; current status not verified) | 2023-10-30 | Ph3 recruiting (CT.gov); NMPA combo IND approvals 2025-06-20 | 2025-06-20 | www.biospace.com static.cninfo.com.cn clinicaltrials.gov | 2025-06-21 |
| 33 | SHR-A2009 | | Jiangsu Hengrui Pharmaceuticals | China | HER3 | Topoisomerase I inhibitor | Phase 3 | EGFR-mutant advanced NSCLC (post-TKI; and 1L + aumolertinib) | NCT06671379; NCT07183189; NCT07895992 | | | New Ph3 (with bevacizumab, nsqNSCLC) registered, start 2026-11-30 | 2026-11-30 (planned) | db.antibodysociety.org clinicaltrials.gov | 2026-10 |
| 34 | SHR-A2102 | | Jiangsu Hengrui Pharmaceuticals | China | Nectin-4 | SHR169265 (topoisomerase I inhibitor) | Phase 3 | Advanced urothelial carcinoma; MIBC; platinum-pretreated (NCT07418749) | NCT06738251; NCT07393542; NCT06879145; NCT07418749 | | | Ph1 published in Lancet Oncology | 2026-09-09 | stock.10jqka.com.cn db.antibodysociety.org clinicaltrials.gov | 2026-09-09 |
| 35 | IBI354 | | Innovent Biologics | China | HER2 | Not disclosed in sources opened (hydrophobic payload, DAR 8) | Phase 3 | Platinum-resistant ovarian cancer (HeriCare-Ovarian01); 1L HER2+ mBC (HeriCare-Breast01) | NCT06834672; NCT07377643 | | | ESMO 2026 Ph2 data (1L HER2+ BC + pertuzumab, ORR 95%) | 2026-10-25 | www.prnewswire.com clinicaltrials.gov | 2026-10-25 |
| 36 | FDA018 | | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical | China | TROP2 | SN-38 (topoisomerase I inhibitor) | Phase 3 | Taxane-pretreated la/m TNBC | NCT06519370 | | | Ph3 active, not recruiting (CT.gov update 2026-01-22) | 2026-01-22 | db.antibodysociety.org clinicaltrials.gov | 2026-01-22 |
| 37 | SHR-A1912 | | Jiangsu Hengrui Pharmaceuticals | China | CD79b | SHR9265 (topoisomerase I inhibitor) | Phase 3 | R/R DLBCL (+ R-GemOx) | NCT06929624 | | | Ph3 active, not recruiting (CT.gov update 2026-09-25) | 2026-09-25 | adcdb.idrblab.cn clinicaltrials.gov | 2026-09-25 |
| 38 | MHB088C | | Minghui Pharmaceutical | China | B7-H3 | Not verified | Phase 3 | Relapsed SCLC vs physician's choice | NCT06954246 (Qilu-sponsored) | Minghui retains ex-Greater China rights (Qilu licensed Greater China) | 2025-05 (Qilu, Greater China) | Ph3 recruiting (started 2025-06-04) | 2025-06-04 | www.fiercebiotech.com www.apexonco.com clinicaltrials.gov | 2025-06-18 |
| 39 | YL202 / BNT326 | | MediLink Therapeutics | China | HER3 | Not verified | Phase 3 | HR+/HER2- breast cancer; EGFR-sensitizing NSCLC vs docetaxel | NCT07461454; NCT07416994 | BioNTech (ex-China, HK, Macau) - current status not re-verified | 2023 (~Oct, per FierceBiotech) | Two pivotal Ph3 trials started in China (Mar 2026) | 2026-03-18 | www.fiercebiotech.com clinicaltrials.gov | 2026-03-18 |
| 40 | JS107 | | Shanghai Junshi Biosciences (TopAlliance) | China | CLDN18.2 | MMAE (tubulin inhibitor) | Phase 3 | 2L+ CLDN18.2+ gastric/GEJ adenocarcinoma; 1L combo | NCT07284134; NCT07584135 | | | Ph3 started (2025-12-24); 1L combo Ph3 started 2026-05-28 | 2026-05-28 | adcdb.idrblab.cn clinicaltrials.gov | 2026-05 |