First Prescription for COSELA® (trilaciclib) Issued in China

- COSELA^®, the world's first and only myeloprotection drug, was prescribed in Jilin Cancer Hospital on January 28, 2023

- Simcere delivers drug to patients in 908 days from execution of license agreement to first prescription

NANJING, China, Feb. 9, 2023 /PRNewswire/ -- Simcere Pharmaceutical Group Limited (2096.HK) ("Simcere"), an innovative global biopharmaceutical company, and G1 Therapeutics, Inc., (Nasdaq: GTHX) ("G1 Therapeutics"), a commercial-stage oncology company, announce a significant milestone in the fight against cancer with the issuance of the first prescription for COSELA^® (trilaciclib) in China.

COSELA is a first-in-class FDA and NMPA-approved therapy 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 (ES-SCLC). Myelosuppression induced by chemotherapy is a common toxic side effect in the clinical treatment of SCLC. COSELA has been shown to significantly reduce chemotherapy-induced myelosuppression, a common and potentially serious side effect of chemotherapy that can result in decreased white blood cell counts, increased risk of infections, and prolonged hospitalization.

"The issuance of the first prescription for COSELA in China is an important step forward in improving outcomes for cancer patients treated with chemotherapy," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We are proud to be working with Simcere to bring this innovative treatment option to patients in China and around the world."

"As a leading pharmaceutical company in China, this approval helps address a huge unmet clinical need in China for an effective solution to decrease the incidence of myelosuppression before it takes place," said Dr. Tang Renhong, Ph.D., Executive Director of the Board, Simcere. "Furthermore, the availability of COSELA in China in under three years from licensing the drug to prescription for patients is a truly remarkable feat and marks a significant step forward in the fight against cancer and we are proud to be a part of it."

About COSELA^®

COSELA (trilaciclib) is a first-in-class comprehensive myeloprotection drug to mitigate chemotherapy-induced myelosuppression on all hematopoietic lineages. It has been approved for marketing in both China and the United States as a myeloprotective treatment administered prior to chemotherapy for extensive small-stage cell lung cancer (ES-SCLC). The product is recommended in the U.S. by two updated 2022 National Comprehensive Cancer Network^® (NCCN^®) Clinical Practice Guidelines and in China by the 2022 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of SCLC.

In August 2020, Simcere reached an exclusive license with G1 to obtain COSELA's development and commercialization interests of all indications in Greater China. In January, April and June 2021, three phase III clinical trials in patients with SCLC, metastatic colorectal cancer and triple negative breast cancer, were carried out in China respectively. In November 2021, the NMPA accepted the New Drug Application (NDA) by COSELA for registration and marketing of overseas manufactured drugs. In December 2021, the drug was granted priority review for COSELA to be used in patients with extensive-stage small cell lung cancer prior to chemotherapy. In February 2022, the pivotal phase III clinical trials (TRACES study) reached the primary endpoint. The research results disclosed in the abstracts at 2022 World Conference on Lung Cancer (WCLC) further confirmed that administration of trilaciclib prior to chemotherapy for the treatment of patients with ES-SCLC improves the patient tolerability of chemotherapy, as demonstrated by a reduction in DSN and improved overall safety profile.

About Simcere

Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The Company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D and commercial stage collaborations have made it a strategic alliance partner with world leading innovative companies and research institutes.

For more information, please visit: http://en.simcere.com/

[email protected] 

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^®. G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating trilaciclib 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.

Forward-Looking Statements

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 COSELA's efficacy in the treatment of small cell lung cancer; the approval of COSELA for the treatment of other cancers, including, but not limited to, bladder cancer, colorectal cancer, breast cancer or other types of cancer; the ability to have COSELA approved as an agnostic treatment for cancer; and the approval of COSELA in countries other than China and the United States, are based on Simcere's and G1 Therapeutics' expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties.  Factors that may cause Simcere's and G1 Therapeutics' actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics' filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, G1 Therapeutics' ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates for various cancers in numerous global markets; Simcere's and G1 Therapeutics' 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 market conditions. Except as required by law, Simcere and G1 Therapeutics assume no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

SOURCE Simcere