Drug Type Biosimilar, Monoclonal antibody |
Synonyms Trastuzumab Biosimilar (Shanghai Henlius Biotech, Inc.), TRASTUZUMAB-STRF, 曲妥珠单抗生物类似药(Shanghai Henlius Biotech, Inc.) + [9] |
Target |
Mechanism HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date |
Regulation- |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HER2 positive Gastrooesophageal junction cancer | AU | 18 Jul 2022 | |
HER2 Positive Breast Cancer | CN | 12 Aug 2020 | |
HER2-positive gastric cancer | CN | 12 Aug 2020 | |
Breast Cancer | EU | 27 Jul 2020 | |
Breast Cancer | IS | 27 Jul 2020 | |
Breast Cancer | LI | 27 Jul 2020 | |
Breast Cancer | NO | 27 Jul 2020 | |
Early Stage Breast Carcinoma | EU | 27 Jul 2020 | |
Early Stage Breast Carcinoma | IS | 27 Jul 2020 | |
Early Stage Breast Carcinoma | LI | 27 Jul 2020 | |
Early Stage Breast Carcinoma | NO | 27 Jul 2020 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | EU | 27 Jul 2020 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | IS | 27 Jul 2020 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | LI | 27 Jul 2020 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | NO | 27 Jul 2020 | |
HER2 Positive Stomach Adenocarcinoma | EU | 27 Jul 2020 | |
HER2 Positive Stomach Adenocarcinoma | IS | 27 Jul 2020 | |
HER2 Positive Stomach Adenocarcinoma | LI | 27 Jul 2020 | |
HER2 Positive Stomach Adenocarcinoma | NO | 27 Jul 2020 | |
Hormone receptor positive breast cancer | EU | 27 Jul 2020 |
Phase 3 | 652 | zekmtknvdd(psuclyzmhq) = rekjjqltbc dkvlqjenai (rmaffaaxaw, uxtdfkgpvp - gnqawkotay) View more | - | 17 May 2024 | |||
Herceptin®+Docetaxel (Herceptin®+Docetaxel) | zekmtknvdd(psuclyzmhq) = tpeydhfnas dkvlqjenai (rmaffaaxaw, aytycqsdal - vclpcfliyi) View more | ||||||
FDA_CDER Manual | Not Applicable | Metastatic breast cancer HER2 Positive | 222 | maijnabqpk(juiigqheuj) = wbpnekmwpc etvkvqhlyn (gmdzrkkuvt ) View more | Positive | 25 Apr 2024 | |
FDA_CDER Manual | Not Applicable | HER2 Positive Breast Cancer ERBB2 Amplification | HER2 Overexpression | 3,386 | Chemo → Trastuzumab (one-year trastuzumab treatment) | lcpeguluzf(fikuigjtfc) = tjxrnxlrva zmnzxvnaqj (gxwjahyhob ) View more | Positive | 25 Apr 2024 |
FDA_CDER Manual | Not Applicable | Metastatic breast cancer HER2 Positive | - | Trastuzumab + All Chemotherapy | bkkwhhngyl(owfmpdnjyj) = jcgyozxioq xixvekzrbz (gfqodkrmyy, 7~8) View more | Positive | 25 Apr 2024 |
All Chemotherapy | bkkwhhngyl(owfmpdnjyj) = ydlpkcajqb xixvekzrbz (gfqodkrmyy, 4~5) View more | ||||||
FDA_CDER Manual | Not Applicable | HER2 Positive Breast Cancer ERBB2 Amplification | 3,222 | xhabawtxmp(yfsqruepez) = obbyifinno cdzrmzgher (zldhwufrbx ) View more | Positive | 25 Apr 2024 | |
xhabawtxmp(yfsqruepez) = wnhyzgguxf cdzrmzgher (zldhwufrbx ) View more | |||||||
FDA_CDER Manual | Not Applicable | HER2 Positive Breast Cancer ERBB2 Amplification | HER2 Expression | 4,063 | vyoyrapldt(jelauwvmaw) = xcnbuuefrr gefwiwtjxi (ygtrpxxmui ) View more | Positive | 25 Apr 2024 | |
vyoyrapldt(jelauwvmaw) = dziirxcipl gefwiwtjxi (ygtrpxxmui ) View more | |||||||
FDA_CDER Manual | Not Applicable | Metastatic Gastric Carcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma HER2 Overexpression | ERBB2 Amplification | 594 | Trastuzumab in combination with cisplatin and a fluoropyrimidine (FC+H) | gndhmgslaj(opesmgfrdu) = ogtdjdusen ztapfgmasj (kamdzdkjqa, 11.7~15.7) View more | Positive | 25 Apr 2024 |
Chemotherapy alone (FC) | gndhmgslaj(opesmgfrdu) = agjpxetjir ztapfgmasj (kamdzdkjqa, 9.4~12.5) View more | ||||||
Not Applicable | Metastatic human epidermal growth factor 2 positive carcinoma of breast First line estrogen receptor-positive | 55 | HLX02, pertuzumab, and chemotherapy | syrxonotog(wiondkhruk) = aowpqxxnyh ltfciwbvxi (mxnpebcvyh, 16.9 - not estimated) View more | - | 15 May 2023 | |
Phase 1 | 18 | (Cohort 1A (Trastuzumab + Utomilumab)) | fxaelysgyh(qictuqaaoc) = cvflmmdkoz ludtcmkkkp (adcquuaggy, bpwjvmysox - balhxyfryo) View more | - | 19 Oct 2022 | ||
(Cohort 1B (Trastuzumab + Utomilumab)) | fxaelysgyh(qictuqaaoc) = lmbrwepvbq ludtcmkkkp (adcquuaggy, rbnyxvvyrg - lnoefncejt) View more | ||||||
Phase 3 | 649 | qmgrkyncio(ifwnwegleu) = essfyzpwsc iisdbiewcq (sykwxrfmff ) View more | Similar | 19 Jul 2022 | |||
qmgrkyncio(ifwnwegleu) = ifbyxhetix iisdbiewcq (sykwxrfmff ) View more |