RESEARCH TRIANGLE PARK, N.C., July 13, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced 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. 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.
"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.
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.
This information is not comprehensive. Please click here for full Prescribing Information. https://www.g1therapeutics.com/cosela/pi/
To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating COSELA in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.
G1 Therapeutics™ and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the potential for COSELA to change the chemotherapy experience for appropriate patients in China who are battling ES-SCLC and the projected number of cancer patients in China. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the company’s dependence on the commercial success of COSELA; the development and commercialization of new drug products is highly competitive; the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
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Director, Corporate Communications and Public Relations
Source: G1 Therapeutics