Drugs / Trilaciclib
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed small cell lung carcinoma 1 milestone | |||||
| Filed | China (NMPA) | COSELA | small cell lung carcinoma | 2023-08-15 | “a New Drug Application (NDA) for new indication for COSELA® (trilaciclib hydrochloride for injection) was accepted by the China National Medical Product Administration (NMPA).” simcere.com ↗ “The Phase III clinical trial (TRACES study) of Trilaciclib in ES-SCLC patients took only 10 months from the first Chinese IND to NDA submission” simcere.com ↗ “In November 2021, the NMPA accepted the New Drug Application (NDA) by COSELA® for registration and marketing of overseas manufactured drugs.” simcere.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | COSELA | — | 2021-02-12 | fda.gov ↗ |
Trials 43
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Cosela® Receives Approval for a New Indication, Expanding Full-Cycle, Multi-Lineage Myeloprotection Across All Chemotherapy Lines for Extensive-Stage Small Cell Lung Cancer simcere.com ↗
After this approval, Cosela® now provides myeloprotection across all chemotherapy lines for extensive-stage small cell lung cancer (ES-SCLC), further expanding its treatment coverage across the disease continuum. |
| 2023-12-28 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory LOCALIZATION APPLICATION OF COSELA® (TRILACICLIB HYDROCHLORIDE FOR INJECTION) APPROVED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION OF CHINA simcere.com ↗
COSELA® (Trilaciclib Hydrochloride for Injection), an innovative oncology product co-developed by Simcere and G1 Therapeutics and currently marketed in China by Simcere Zaiming has obtained the approval notice of Supplementary Application of Drugs issued by the National Medical Products Administration of China (the “NMPA”). |
| 2023-12-09 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results SABCS Voice from China | Simcere Zaiming's brain penetrating SERD molecule for advanced ER+/Her2- breast cancer SIM0270 published its first-in-human data simcere.com ↗
Prior trilaciclib plus GCb significantly prolonged survival of patients with Triple Negative Breast Cancer who recieved subsequent anticancer therapy by nearly 20 months, compared to GCb alone. |
| 2023-11-07 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory COSELA® granted full approval by NMPA simcere.com ↗
COSELA® granted full approval by NMPA |
| 2023-08-15 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory COSELA® new indication NDA accepted by China NMPA simcere.com ↗
On August 15, 2023, Simcere Zaiming Pharmaceutical Co., Ltd. announced that a New Drug Application (NDA) for new indication for COSELA® (trilaciclib hydrochloride for injection) was accepted by the China National Medical Product Administration (NMPA). |
| 2023-06-06 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Simcere Zaiming showcases the latest R&D progress on its debut at 2023 ASCO annual meeting simcere.com ↗
Safety and tolerability data are encouraging for trilaciclib in combination with AC/T ± pembrolizumab ± carboplatin in the neoadjuvant setting for early-stage TNBC. |
| 2023-05-11 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results ESMO Breast Cancer：New Results from Phase 2 Trial Confirm Benefit of Trilaciclib in Reducing Adverse Events Related to an Antibody Drug Conjugate (ADC) simcere.com ↗
These data highlight the potential for trilaciclib to meaningfully reduce adverse events related to use of sacituzumab . |
| 2022-11-18 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Trilaciclib RWS data featured at 2022 CSCO Annual Meeting: synergistic innovation enabled Chinese lung cancer patients to have preemptive access to international new drugs simcere.com ↗
The RWS data published at CSCO further validated the safety and efficacy of this drug while also demonstrates the potential of this innovative collaboration with the region as a promising step forward to bringing future medicines at an accelerated pace. |
| 2022-07-15 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results COSELA® Clinical Data Disclosed at WCLC 2022, Myeloprotection Effect in Chinese Patient Confirmed by TRACES Study simcere.com ↗
Study results have confirmed that the safety and myeloprotection effect of trilaciclib in Chinese patient are consistent with the previously published clinical data in the Western population. |
| 2022-07-13 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory COSELA®, the World's First Comprehensive Myeloprotection Drug against Chemotherapy Damage, Wins Approval in China simcere.com ↗
On July 13 2022, Simcere Pharmaceuticals (02096.HK) announced that the China National Medical Products Administration (NMPA) has conditionally approved COSELA® (trilaciclib hydrochloride for injection), an innovative myeloprotection drug jointly developed in China by Simcere and G1 Therapeutics. |
| 2022-02-24 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Results Primary endpoint met in Phase III clinical trial of Trilaciclib in Chinese patients with small cell lung cancer simcere.com ↗ |
| 2022-01-10 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Trilaciclib Received Priority Review from NMPA! Patient Enrolment Achieved for Three Indications in Phase III Study in China simcere.com ↗ |
| 2021-07-30 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Trilaciclib Granted Fast Track Designation by the U.S. FDA for Use in Combination with Chemotherapy for the Treatment of TNBC simcere.com ↗
On 19 June 2021, the U.S. Food and Drug Administration has granted Trilaciclib (COSELA TM ) the Fast Track Designation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple-negative breast cancer (mTNBC). |
| 2021-06-18 | Jiangsu Simcere Pharmaceutical Co., Ltd. | Regulatory Simcere Announces the Approval of Clinical Trial Application by NMPA to Initiate China Phase Ⅲ Study Sites for the Global Clinical Trial of Trilaciclib in the Treatment of Triple-Negative Breast Cancer (TNBC) simcere.com ↗
On June 10, Simcere Pharmaceutical Group Limited (2096.HK) announced that the clinical trial application for trilaciclib, an innovative drug being developed in cooperation with G1 Therapeutics, INC. (Nasdaq: GTHX), has been approved by the National Medical Products Administration (NMPA), PRC. |
All press releases naming this drug 26 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trilaciclib | “Trilaciclib: 240 mg/m², administered via intravenous infusion over 30 minutes, completed within 4 hours prior to chemotherapy on the same day.” NCT07160283 ↗ |
| Known as | Cosela | “Experimental: trilaciclib group Intervention: Drug: Trilaciclib Injection \[Cosela\] 240 mg/m\^2, intravenous drip over 30 min within 4 hours before chemotherapy administration...” NCT06297811 ↗ |
| Action | Inhibit | “CDK4/6 inhibitor” PMID 33595690 ↗ Feb 2021 |
| Route | Intravenous | “Trilaciclib: 240 mg/m2 IV weekly cycle 1-16” NCT01042379 ↗ |
| Target | CDK4 | “CDK4/6 inhibitor” PMID 33595690 ↗ Feb 2021 |