JP2022036932A5 - - Google Patents
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- JP2022036932A5 JP2022036932A5 JP2021171589A JP2021171589A JP2022036932A5 JP 2022036932 A5 JP2022036932 A5 JP 2022036932A5 JP 2021171589 A JP2021171589 A JP 2021171589A JP 2021171589 A JP2021171589 A JP 2021171589A JP 2022036932 A5 JP2022036932 A5 JP 2022036932A5
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- 239000000203 mixture Substances 0.000 claims description 153
- 239000007788 liquid Substances 0.000 claims description 109
- 229930006000 Sucrose Natural products 0.000 claims description 33
- 239000005720 sucrose Substances 0.000 claims description 33
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 29
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 29
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 29
- 229940068977 polysorbate 20 Drugs 0.000 claims description 29
- 239000000872 buffer Substances 0.000 claims description 28
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 25
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 24
- KZSNJWFQEVHDMF-UHFFFAOYSA-N Valine Chemical compound CC(C)C(N)C(O)=O KZSNJWFQEVHDMF-UHFFFAOYSA-N 0.000 claims description 24
- 239000004094 surface-active agent Substances 0.000 claims description 24
- 229940074404 sodium succinate Drugs 0.000 claims description 23
- ZDQYSKICYIVCPN-UHFFFAOYSA-L sodium succinate (anhydrous) Chemical group [Na+].[Na+].[O-]C(=O)CCC([O-])=O ZDQYSKICYIVCPN-UHFFFAOYSA-L 0.000 claims description 23
- 239000008362 succinate buffer Substances 0.000 claims description 23
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims description 20
- 238000001990 intravenous administration Methods 0.000 claims description 18
- KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical compound CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 claims description 12
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 12
- 239000004474 valine Substances 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 12
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 11
- 230000002062 proliferating effect Effects 0.000 claims description 11
- 239000008227 sterile water for injection Substances 0.000 claims description 11
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 9
- 210000003719 b-lymphocyte Anatomy 0.000 claims description 8
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims description 8
- 125000000185 sucrose group Chemical group 0.000 claims description 8
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims description 7
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims description 7
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims description 7
- 230000000306 recurrent effect Effects 0.000 claims description 7
- 230000001684 chronic effect Effects 0.000 claims description 6
- 201000003444 follicular lymphoma Diseases 0.000 claims description 6
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims description 4
- 206010025323 Lymphomas Diseases 0.000 claims description 4
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 4
- 125000000487 histidyl group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims description 4
- 208000032839 leukemia Diseases 0.000 claims description 4
- HEGSGKPQLMEBJL-UHFFFAOYSA-N n-octyl beta-D-glucopyranoside Natural products CCCCCCCCOC1OC(CO)C(O)C(O)C1O HEGSGKPQLMEBJL-UHFFFAOYSA-N 0.000 claims description 4
- HEGSGKPQLMEBJL-RKQHYHRCSA-N octyl beta-D-glucopyranoside Chemical compound CCCCCCCCO[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HEGSGKPQLMEBJL-RKQHYHRCSA-N 0.000 claims description 4
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 4
- 229920000053 polysorbate 80 Polymers 0.000 claims description 4
- 229940068968 polysorbate 80 Drugs 0.000 claims description 4
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 3
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims description 3
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims description 3
- 229940119744 dextran 40 Drugs 0.000 claims description 3
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 229920001993 poloxamer 188 Polymers 0.000 claims description 3
- 229940044519 poloxamer 188 Drugs 0.000 claims description 3
- 239000000600 sorbitol Substances 0.000 claims description 3
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims description 2
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims description 2
- 206010035226 Plasma cell myeloma Diseases 0.000 claims description 2
- 201000000050 myeloid neoplasm Diseases 0.000 claims description 2
- 229940127121 immunoconjugate Drugs 0.000 claims 11
- 150000001413 amino acids Chemical group 0.000 claims 4
- 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 2
- 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 2
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 2
- 208000035475 disorder Diseases 0.000 claims 2
- 201000009277 hairy cell leukemia Diseases 0.000 claims 2
- 238000010253 intravenous injection Methods 0.000 claims 2
- 239000002736 nonionic surfactant Substances 0.000 claims 2
- 238000007865 diluting Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 description 92
- 125000003275 alpha amino acid group Chemical group 0.000 description 22
- 239000000243 solution Substances 0.000 description 10
- 238000000034 method Methods 0.000 description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 8
- 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 description 6
- 238000004108 freeze drying Methods 0.000 description 4
- 239000011780 sodium chloride Substances 0.000 description 4
- 238000010790 dilution Methods 0.000 description 3
- 239000012895 dilution Substances 0.000 description 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 2
- 230000002378 acidificating effect Effects 0.000 description 2
- 201000011510 cancer Diseases 0.000 description 2
- 238000000533 capillary isoelectric focusing Methods 0.000 description 2
- 238000003384 imaging method Methods 0.000 description 2
- 239000001384 succinic acid Substances 0.000 description 2
- 239000012190 activator Substances 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000022534 cell killing Effects 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 210000002768 hair cell Anatomy 0.000 description 1
- 230000009545 invasion Effects 0.000 description 1
- 210000002751 lymph Anatomy 0.000 description 1
- 230000001568 sexual effect Effects 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2024194712A JP2025032097A (ja) | 2018-04-13 | 2024-11-06 | 安定した抗ｃｄ７９ｂ免疫複合体製剤 |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862657185P | 2018-04-13 | 2018-04-13 | |
| US62/657,185 | 2018-04-13 | ||
| JP2019076133A JP6761506B2 (ja) | 2018-04-13 | 2019-04-12 | 安定した抗ｃｄ７９ｂイムノコンジュゲート製剤 |
| JP2020079093A JP6965395B2 (ja) | 2018-04-13 | 2020-04-28 | 安定した抗ｃｄ７９ｂ免疫複合体製剤 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020079093A Division JP6965395B2 (ja) | 2018-04-13 | 2020-04-28 | 安定した抗ｃｄ７９ｂ免疫複合体製剤 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2024194712A Division JP2025032097A (ja) | 2018-04-13 | 2024-11-06 | 安定した抗ｃｄ７９ｂ免疫複合体製剤 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2022036932A JP2022036932A (ja) | 2022-03-08 |
| JP2022036932A5 true JP2022036932A5 (enExample) | 2022-04-25 |
| JP7585177B2 JP7585177B2 (ja) | 2024-11-18 |
Family
ID=68161211
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019076133A Active JP6761506B2 (ja) | 2018-04-13 | 2019-04-12 | 安定した抗ｃｄ７９ｂイムノコンジュゲート製剤 |
| JP2020079093A Active JP6965395B2 (ja) | 2018-04-13 | 2020-04-28 | 安定した抗ｃｄ７９ｂ免疫複合体製剤 |
| JP2021171589A Active JP7585177B2 (ja) | 2018-04-13 | 2021-10-20 | 安定した抗ｃｄ７９ｂ免疫複合体製剤 |
| JP2024194712A Pending JP2025032097A (ja) | 2018-04-13 | 2024-11-06 | 安定した抗ｃｄ７９ｂ免疫複合体製剤 |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019076133A Active JP6761506B2 (ja) | 2018-04-13 | 2019-04-12 | 安定した抗ｃｄ７９ｂイムノコンジュゲート製剤 |
| JP2020079093A Active JP6965395B2 (ja) | 2018-04-13 | 2020-04-28 | 安定した抗ｃｄ７９ｂ免疫複合体製剤 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2024194712A Pending JP2025032097A (ja) | 2018-04-13 | 2024-11-06 | 安定した抗ｃｄ７９ｂ免疫複合体製剤 |
Country Status (17)
| Country | Link |
|---|---|
| US (2) | US11648317B2 (enExample) |
| EP (1) | EP3773721A4 (enExample) |
| JP (4) | JP6761506B2 (enExample) |
| KR (1) | KR20210003147A (enExample) |
| CN (3) | CN118615457A (enExample) |
| AR (1) | AR114780A1 (enExample) |
| AU (1) | AU2019252941B2 (enExample) |
| CA (1) | CA3095186A1 (enExample) |
| CL (2) | CL2020002624A1 (enExample) |
| CR (2) | CR20250325A (enExample) |
| IL (1) | IL277943A (enExample) |
| MX (2) | MX2020010729A (enExample) |
| MY (1) | MY203529A (enExample) |
| PE (2) | PE20201503A1 (enExample) |
| TW (3) | TWI848769B (enExample) |
| UA (1) | UA128064C2 (enExample) |
| WO (1) | WO2019200322A1 (enExample) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2643239T3 (es) * | 2008-01-31 | 2017-11-21 | Genentech, Inc. | Anticuerpos anti-CD79b e inmunoconjugados y métodos de uso |
| DK3262071T3 (da) | 2014-09-23 | 2020-06-15 | Hoffmann La Roche | Fremgangsmåde til anvendelse af anti-CD79b-immunkonjugater |
| CR20250325A (es) * | 2018-04-13 | 2025-08-29 | Genentech Inc | Formulaciones inmunoconjugadas anti-cd79b estables (divisional expediente 2020-0550) |
| AU2018451747A1 (en) * | 2018-12-06 | 2021-06-17 | F. Hoffmann-La Roche Ag | Combination therapy of diffuse large B-cell lymphoma comprising an anti-CD79b immunoconjugates, an alkylating agent and an anti-CD20 antibody |
| KR20220007136A (ko) * | 2019-05-14 | 2022-01-18 | 제넨테크, 인크. | 소포 림프종을 치료하기 위한 항-CD79b 면역접합체의 사용 방법 |
| WO2021076196A1 (en) * | 2019-10-18 | 2021-04-22 | Genentech, Inc. | Methods of using anti-cd79b immunoconjugates to treat diffuse large b-cell lymphoma |
| BR112023001359A2 (pt) * | 2020-07-27 | 2023-02-14 | Tuojie Biotech Shanghai Co Ltd | Conjugado de anticorpo-fármaco anti-cd79b, método de preparação do mesmo e uso farmacêutico do mesmo |
| CN115957339A (zh) * | 2021-09-16 | 2023-04-14 | 正大天晴药业集团股份有限公司 | 抗体药物偶联物及其组合物和用途 |
| KR20240135622A (ko) * | 2022-01-26 | 2024-09-11 | 상하이 맙젠 바이오텍 리미티드 | 항CD79b 항체-약물 접합체의 약학적 조성물 및 이의 용도 |
| WO2025221694A1 (en) * | 2024-04-15 | 2025-10-23 | DiaMedica Therapeutics, Inc. | Intravenous compositions of tissue kallikrein-1 and related methods |
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| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| DE3587657D1 (de) | 1984-01-30 | 1993-12-23 | Imp Cancer Res Tech | Verbesserungen an wachstumsfaktoren. |
| US5401638A (en) | 1986-06-04 | 1995-03-28 | Oncogene Science, Inc. | Detection and quantification of neu related proteins in the biological fluids of humans |
| IL85035A0 (en) | 1987-01-08 | 1988-06-30 | Int Genetic Eng | Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same |
| DE3920358A1 (de) | 1989-06-22 | 1991-01-17 | Behringwerke Ag | Bispezifische und oligospezifische, mono- und oligovalente antikoerperkonstrukte, ihre herstellung und verwendung |
| WO1991005264A1 (en) | 1989-09-29 | 1991-04-18 | Oncogenetics Partners | Detection and quantification of neu related proteins in the biological fluids of humans |
| US6075181A (en) | 1990-01-12 | 2000-06-13 | Abgenix, Inc. | Human antibodies derived from immunized xenomice |
| US6150584A (en) | 1990-01-12 | 2000-11-21 | Abgenix, Inc. | Human antibodies derived from immunized xenomice |
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| CA2109861C (en) | 1992-12-04 | 1999-03-16 | Shu-Hui Chen | 6,7-modified paclitaxels |
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| ATE186219T1 (de) | 1993-03-24 | 1999-11-15 | Berlex Biosciences | Kombination von antihormonale und bindende moleküle zur krebsbehandlung |
| US5663149A (en) | 1994-12-13 | 1997-09-02 | Arizona Board Of Regents Acting On Behalf Of Arizona State University | Human cancer inhibitory pentapeptide heterocyclic and halophenyl amides |
| US5641870A (en) | 1995-04-20 | 1997-06-24 | Genentech, Inc. | Low pH hydrophobic interaction chromatography for antibody purification |
| PT1516628E (pt) * | 1995-07-27 | 2013-09-24 | Genentech Inc | Formulação de proteína liofilizada isotónica estável |
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| CN107213469A (zh) | 2003-11-06 | 2017-09-29 | 西雅图基因公司 | 能够与配体偶联的单甲基缬氨酸化合物 |
| JP2009503105A (ja) * | 2005-08-03 | 2009-01-29 | イミュノジェン・インコーポレーテッド | 免疫複合体製剤 |
| NZ583367A (en) * | 2007-07-16 | 2012-10-26 | Genentech Inc | Anti-cd79b antibodies and immunoconjugates and methods of use |
| ES2643239T3 (es) * | 2008-01-31 | 2017-11-21 | Genentech, Inc. | Anticuerpos anti-CD79b e inmunoconjugados y métodos de uso |
| CA2749115C (en) * | 2009-01-09 | 2022-06-21 | Seattle Genetics, Inc. | Weekly dosing regimens for anti-cd30 vc-pab-mmae antibody drug-conjugates |
| AR084158A1 (es) * | 2010-12-10 | 2013-04-24 | Merck Sharp & Dohme | Formulaciones que mitigan la agregacion inducida por agitacion de composiciones inmunogenicas |
| WO2014011521A1 (en) | 2012-07-09 | 2014-01-16 | Genentech, Inc. | Immunoconjugates comprising anti - cd79b antibodies |
| AR096183A1 (es) * | 2013-05-02 | 2015-12-16 | Hoffmann La Roche | Terapia de combinación de un anticuerpo para cd20 afucosilado con un conjugado de anticuerpo para cd79b-fármaco |
| MX377841B (es) * | 2013-11-21 | 2025-03-11 | Genmab As | Formulación liofilizada de conjugado de anticuerpo-fármaco. |
| JP2015209384A (ja) * | 2014-04-24 | 2015-11-24 | ミレニアム ファーマシューティカルズ， インコーポレイテッドＭｉｌｌｅｎｎｉｕｍ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． | 医薬製剤 |
| DK3262071T3 (da) | 2014-09-23 | 2020-06-15 | Hoffmann La Roche | Fremgangsmåde til anvendelse af anti-CD79b-immunkonjugater |
| CR20250325A (es) * | 2018-04-13 | 2025-08-29 | Genentech Inc | Formulaciones inmunoconjugadas anti-cd79b estables (divisional expediente 2020-0550) |
-
2018
- 2018-04-13 CR CR20250325A patent/CR20250325A/es unknown
-
2019
- 2019-04-12 CN CN202410751629.3A patent/CN118615457A/zh active Pending
- 2019-04-12 CA CA3095186A patent/CA3095186A1/en active Pending
- 2019-04-12 US US16/383,478 patent/US11648317B2/en active Active
- 2019-04-12 TW TW112126392A patent/TWI848769B/zh active
- 2019-04-12 TW TW108112935A patent/TWI811335B/zh active
- 2019-04-12 KR KR1020207032399A patent/KR20210003147A/ko not_active Ceased
- 2019-04-12 CR CR20200550A patent/CR20200550A/es unknown
- 2019-04-12 MY MYPI2020005286A patent/MY203529A/en unknown
- 2019-04-12 WO PCT/US2019/027329 patent/WO2019200322A1/en not_active Ceased
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2020
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2021
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2023
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2024
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