COSELA®, the World's First Comprehensive Myeloprotection Drug against Chemotherapy Damage, Wins Approval in China

NANJING, China, July 18, 2022 /PRNewswire/ -- 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. The product is approved 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.

A'Bullet-Proof Vest' for the Bone Marrow

Chemotherapy has been considered the cornerstone in the treatment of many types of cancer. It is predicted that by 2040, the number of new cancer patients requiring chemotherapy in China will reach 4.2 million. However, the incidence of toxic side effects caused by chemotherapy is extremely high, which has a profound impact on the efficacy of chemotherapy. Myelosuppression is associated with 80% of chemotherapy drugs, which affects therapeutic effect and prognosis in 64% of the patients. Myelosuppression significantly increases the risk of severe infection, hemorrhage, and anemia, reducing patients' quality of life and even resulting in life-threatening conditions, which also increases their financial burdens. Furthermore, myelosuppression may also lead to dose reduction or delay of chemotherapy, which has a direct impact on the therapeutic effect.

Clinically, the common approaches to resolve myelosuppression are transfusion of blood cells or infusion of various colony-stimulating factors to increase blood cell production by bone marrow hematopoietic stem/progenitor cells. However，such approaches have limitations，such as potentially leading to bone marrow depletion, with diminishing effects over long periods of time, often bring additional adverse effects such as aching in the bone. Moreover, these remedial methods can only supplement a single lineage such as white blood cell or platelet at a time, with no comprehensive prevention on myelosuppression. Patients receiving chemotherapy urgently need a treatment regimen that can work like a 'bullet proof vest', offering comprehensive protection against bone marrow damage during cancer treatment without influencing the anti-tumor effect of chemotherapy.

To meet the highly unmet clinical demand, Simcere reached an agreement with G1 therapeutics to introduce the world's first comprehensive myeloprotection drug against chemotherapy damage in the Chinese market.

"Myelosuppression induced by chemotherapy is a common toxic side effect in the clinical treatment of SCLC. There has been a huge unmet clinical need in China for an effective solution to prevent or reduce myelosuppression before it takes place," said Professor Ying Cheng, principal investigator of the Phase III pivotal trial (TRACES study) in China at Jilin Cancer Hospital. "The positive results from the TRACES study have confirmed that COSELA^® provides a comprehensive protective effect against myelosuppression in Chinese patients. This product is expected to be used as part of the standard treatment regimen offered to ES-SCLC patients to reduce the toxicity and enhance the efficacy of chemotherapy.

Three published clinical studies (G1T28-05, G1T28-02, and G1T28-03) have shown that patients who received Cosela^® had lower chances of experiencing severe neutropenia, Grade 3/4 anemia, or Grade 3/4 thrombocytopenia compared to patients who received a placebo, thus demonstrating its comprehensive myeloprotection effect on hematopoietic functions of neutrophils, erythrocytes, and platelets.

The research results disclosed in the abstracts at 2022 World Conference on Lung Cancer (WCLC) show that , Compared with placebo, trilaciclib resulted in clinically and statistically significant decrease in DSN in Cycle 1 (0 versus 2 days; P=0.0003). In addition, trilaciclib also significantly decreased occurrence of SN (7.3% versus 45.2%, P< 0.0001), occurrence of FN(2.4% versus 16.7%, P= 0.0267) and incidence of Grade 3 or 4 Hematologic Toxicity (53.7% versus 88.1%, P= 0.0005). Administration of trilaciclib prior to chemotherapy in ES-SCLC patients improved the patient tolerability of chemotherapy, no new safety signals were identified, and the preliminary myeloprotection effect of Trilaciclib in China study was comparable to overseas results.

First-in-Class Novel Drug Enters China

COSELA^® is the world's first and only anti-tumor myeloprotection drug with a First-in-Class (FIC) mechanism. Designated as a "breakthrough therapy" by the US FDA, COSELA^® received approval in the US in 2021. After establishing their strategic collaboration, Simcere and G1 therapeutics have jointly facilitated the rapid introduction of COSELA^® in China.

As a highly potent, selective, and reversible CDK4/6 inhibitor, COSELA^® puts CDK4/6-dependent cells, e.g., hematopoietic stem and progenitor cells (HSPCs) into temporary arrest at the G1 phase of the cell cycle, therefore reducing damage during exposure to chemotherapy. The product is expected to be used as part of the standard treatment regimen against certain cancers as an alternative to various colony-stimulating factors to increase the efficacy and reduce the toxicity of chemotherapy.

With three completed or ongoing registrational clinical trials, the product is being investigated in patients with small cell lung cancer, metastatic colorectal cancer, and triple negative breast cancer in China. 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, and the approval was granted by the NMPA only one year after the initial launch of the product in the US. This reflects the synergistic efficiency of global regulatory, clinical, and pharmaceutical collaboration.

Dr. Renhong Tang，Executive Director and Co-Chief Executive Officer of Simcere said: "An enormous number of patients receiving chemotherapy in China are in urgent need of safer and more effective treatment options. I wish to thank the Simcere team, our partners, and the clinical experts for their concerted efforts that facilitated the rapid development of this First-in-Class and Only-in-Class innovative product in China. Moving forward, Simcere shall continue to advance product commercialization and the expansion of other indications efficiently so as to benefit more patients sooner."

"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."

About COSELA®

COSELA^® (Trilaciclib Hydrochloride for Injection) 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 stage-small 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, the Simcere reached an exclusive authorization contract 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 in the priority review. 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 G1

G1 is a commercial-stage biopharmaceutical company focused on the discovery, development and delivery of next-generation therapies designed to improve the lives of cancer patients.

ABOUT SIMCERE

Simcere Pharmaceutical Group is an innovation and R&D-driven pharmaceutical company. It has established a National Key Laboratory of Translational Medicine and Innovative Drug Development. The Company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with forward-looking layout of disease areas that may have significant clinical needs, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, the Company has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading innovative companies and research institutes.

SOURCE Simcere