Claims for Patent: 11,591,340

Summary for Patent: 11,591,340

Title:	Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Abstract:	The present invention relates to a crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide for inhibiting Btk, methods of preparation thereof and pharmaceutical compositions, and use of the crystalline form above in the treatment of a disease, or in the manufacturing of a medicament for the treatment of a disease.
Inventor(s):	Zhiwei Wang, Yunhang Guo, Gongyin Shi, Lai Wang
Assignee:	BEONE MEDICINES I GMBH
Application Number:	US17/740,882
Patent Claims:	1. A method for treating mantle cell lymphoma in a subject, comprising administering to the subject in need thereof a crystalline form of Compound 1, wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising diffraction peaks having 2θ angle values at 14.8±0.2°, 15.6±0.2°, 16.4±0.2°, and 21.4±0.2°. 2. The method of claim 1, wherein the crystalline form of Compound 1 is administrated at a dose of 40 mg to 320 mg/day. 3. The method of claim 1, wherein the crystalline form of Compound 1 is administered at a dose of 160 mg twice a day (BID). 4. The method of claim 1, wherein the crystalline form of Compound 1 is administered at a dose of 320 mg once a day (QD). 5. The method of claim 1, wherein the crystalline form is an anhydrate. 6. The method of claim 1, wherein the crystalline form of Compound 1 has an Enantiomeric Excess value of greater than 97%. 7. The method of claim 1, wherein the subject has received at least one prior therapy. 8. A method for treating Waldenström's macroglobulinemia in a subject, comprising administering to the subject in need thereof a crystalline form of Compound 1, wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising diffraction peaks having 2θ angle values at 14.8±0.2°, 15.6±0.2°, 16.4±0.2°, and 21.4±0.2°. 9. The method of claim 8, wherein the crystalline form of Compound 1 is administrated at a dose of 40 mg to 320 mg/day. 10. The method of claim 8, wherein the crystalline form of Compound 1 is administered at a dose of 160 mg twice a day (BID). 11. The method of claim 8, wherein the crystalline form of Compound 1 is administered at a dose of 320 mg once a day (QD). 12. The method of claim 8, wherein the crystalline form is an anhydrate. 13. The method of claim 8, wherein the crystalline form of Compound 1 has an Enantiomeric Excess value of greater than 97%. 14. A method for treating marginal zone lymphoma in a subject, comprising administering to the subject in need thereof a crystalline form of Compound 1, wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising diffraction peaks having 2θ angle values at 14.8±0.2°, 15.6±0.2°, 16.4±0.2°, and 21.4±0.2°. 15. The method of claim 14, wherein the crystalline form of Compound 1 is administrated at a dose of 40 mg to 320 mg/day. 16. The method of claim 14, wherein the crystalline form of Compound 1 is administered at a dose of 160 mg twice a day (BID). 17. The method of claim 14, wherein the crystalline form of Compound 1 is administered at a dose of 320 mg once a day (QD). 18. The method of claim 14, wherein the crystalline form is an anhydrate. 19. The method of claim 14, wherein the crystalline form of Compound 1 has an Enantiomeric Excess value of greater than 97%. 20. The method of claim 14, wherein the subject has received at least one prior therapy. 21. A method for treating chronic lymphocytic leukemia or small lymphocytic lymphoma in a subject, comprising administering to the subject in need thereof a crystalline form of Compound 1, wherein the crystalline form exhibits an X-ray powder diffraction pattern comprising diffraction peaks having 2θ angle values at 14.8±0.2°, 15.6±0.2°, 16.4±0.2° and 21.4±0.2°. 22. The method of claim 21, wherein the crystalline form of Compound 1 is administrated at a dose of 40 mg to 320 mg/day. 23. The method of claim 21, wherein the crystalline form of Compound 1 is administered at a dose of 160 mg twice a day (BID). 24. The method of claim 21, wherein the crystalline form of Compound 1 is administered at a dose of 320 mg once a day (QD). 25. The method of claim 21, wherein the crystalline form is an anhydrate. 26. The method of claim 21, wherein the crystalline form of Compound 1 has an Enantiomeric Excess value of greater than 97%. 27. The method of claim 21, wherein the subject has received at least one prior therapy.