Pivotal soj ntsuam daim ntawv thov rau lorlatinib nyob rau hauv ROS1-zoo siab heev uas tsis yog-me me cell ntsws cancer pom zoo nyob rau hauv Tuam Tshoj

Thaum Lub Ib Hlis 4, Hong Kong-raws li lub tuam txhab tshuaj tshiab Cstone Pharmaceuticals (02616.HK) tshaj tawm tias daim ntawv thov kev kho mob (IND) ntawm lorlatinib rau ROS1-zoo siab heev uas tsis yog-mob ntsws qog noj ntshav (NSCLC) tau pom zoo los ntawm National Medical Products Administration ntawm Tuam Tshoj. Tso cai (NMPA) pom zoo. Nov yog lub ntiaj teb' thawj qhov kev tshawb fawb tseem ceeb ntawm lorlatinib hauv ROS1-zoo NSCLC.

Nws tau nkag siab tias txoj kev tshawb fawb no tsom mus rau kev soj ntsuam cov tshuaj tiv thaiv kab mob thiab kev nyab xeeb ntawm lorlatinib hauv cov neeg mob nrog ROS1-zoo siab NSCLC, thiab yuav tso npe cov neeg mob nrog ROS1-zoo siab heev NSCLC uas tau ua tsis tiav cov tshuaj khomob thiab kev kho kom raug. Lub ntsiab lus tseem ceeb ntawm txoj kev tshawb no yog kev soj ntsuam ywj pheej Pawg Neeg Saib Xyuas Lub Hom Phiaj Teb Tus Nqi (ORR).

Kev txheeb cais qhia tau tias muaj ntau dua 670,000 NSCLC tus neeg mob kuaj pom hauv Suav teb txhua xyoo, ntawm 2%-3% yog tshwm sim los ntawm ROS1 gene rearrangement, nrog rau qhov ntsuas ntawm kwv yees li 20,000 tus neeg. Lawv feem ntau yog cov hluas, tsis haus luam yeeb lossis haus luam yeeb lub ntsws adenocarcinomas. hauv cov neeg mob. Raws li ib tiam thib peb ALK/ROS1 tyrosine kinase inhibitor, lorlatinib tuaj yeem muab kev kho mob tshiab rau cov neeg mob uas muaj ROS1-zoo siab heev uas tsis yog mob qog noj ntshav me me.

Hauv qhov no, Dr. Yang Jianxin, Tus Thawj Saib Xyuas Kev Kho Mob ntawm Cstone Pharmaceuticals, tau hais tias tam sim no tsis muaj kev kho mob zoo rau cov neeg mob ROS1-zoo NSCLC tom qab lawv txhim kho cov tshuaj tiv thaiv." Peb zoo siab tias lorlatinib tau pom zoo rau kev tshawb fawb pivotal hauv cov neeg mob ROS1-zoo NSCLC hauv Suav teb. Peb yuav ceev cov kev tshawb fawb soj ntsuam ntawm lorlatinib thiab coj ntau txoj kev kho mob rau cov neeg mob kom sai li sai tau."

It is worth noting that this study is a further deepening of the strategic cooperation between CStone and Pfizer. In September 2020, CStone and Pfizer entered into a strategic cooperation, which includes a cooperation framework for the two parties to introduce more oncology products into the Greater China region. In June 2021, CStone and Pfizer jointly announced that the two parties will jointly develop lorlatinib in the Greater China region and conduct research on ROS1-positive NSCLC, bringing more treatment options to the majority of patients in the field of cancer.

The approval of lorlatinib for pivotal clinical studies is another piece of good news recently obtained by CStone. At the end of last month, the potential best-in-class PD-L1 antibody drug Zejiemei? (Sugalimumab injection) was approved by NMPA for marketing, and the clinical trial application of the potential best-in-class drug CS5001 (ROR1 ADC) in the world was approved by FDA for clinical research. CStone's advantages in precision therapy and immunotherapy are further highlighted.