On July 13, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that the China National Medical Products Administration (NMPA) has conditionally approved COSELA (trilaciclib hydrochloride for injection), which was jointly developed for use in Greater China by Simcere and G1 Therapeutics (Press release, G1 Therapeutics, JUL 13, 2022, View Source [SID1234616640]). COSELA is now indicated in China to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen for extensive-stage small cell lung cancer. As a result of receiving approval in China, G1 will receive a $13 million milestone payment. In total, G1 may receive up to $156M in total milestones. G1 may also receive double-digit royalties on annual net sales of COSELA in China.
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"G1 congratulates our partner Simcere on rapidly progressing the development of COSELA in Greater China and successfully obtaining marketing approval from the National Medical Products Administration," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "China is one of the largest markets globally and there remains a great unmet medical need for an effective solution to prevent or reduce the debilitating myelosuppressive side effects of chemotherapy. We are excited Simcere will now be able to make COSELA available to ES-SCLC patients in Greater China, which represents a critical initial milestone in our mission of improving the lives of those impacted by cancer globally."
It is predicted that, by 2040, the number of new cancer patients requiring chemotherapy in China will reach 4.2 million. While chemotherapy remains the cornerstone of treatment for many cancer types, its toxic side effects have widespread impact on patients and can lead to dose reductions or delays, both of which diminish its therapeutic effect. According to Chinese statistics, myelosuppression is associated with more than 80% of chemotherapy drugs. G1 has partnered with Simcere to jointly conduct clinical trials of trilaciclib in colorectal cancer and triple negative breast cancer.
About COSELA (trilaciclib) for Injection
This is intended for U.S. audiences.
COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.
Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.
Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.
The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.