July sees more pan-tumor therapies approved in China
Danni Yin ·08/15/2022
China NMPA Approval Tracker


China’s pursuit of innovative oncology drugs remained intense in July, as Chinese regulators granted the first marketing approval for three drugs, namely Simcere’s Cosela (trilaciclib), Lepu Biopharma’s Puyouheng (pucotenlimab) and Roche’s Rozlytrek (Entrectinib).


The NMPA also accepted the NDAs for six new candidates including Zai Lab’s Vyvgart (efgartigimod) and BMS’s BMS-986165 (deucravacitinib).


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  Pan solid tumor therapies


July saw the eighth homegrown PD-1 antibody in China, Lepu Biopharma’s Puyouheng (pucotenlimab), getting conditionally approved for patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors.


Before Puyouheng’s green light, Henlius’s Hansizhuang (serplulimab) and BeiGene’s Baize'an (tislelizumab) received the NMPA’s approval for the same indication in March 2022.


Lepu Biopharma’s MSI-H/dMMR targeted therapy is the first cancer treatment for any solid tumor with this specific genetic feature since Keytruda (pembrolizumab) was approved by the FDA in May 2017.


It’s a similar story for NTRK gene fusion. In July, Roche’s Rozlytrek(Entrectinib) was approved by the NMPA for the treatment of any solid tumors with NTRK gene fusions following Bayer's Vitrakvi (larotrectinib) approval in April 2022.


Rozlytrek and Vitrakvi are first generation TRK inhibitors with targeted therapeutic use. Their use are based on whether a patient’s tumor tests positive for a specific genetic biomarker, not where in the body the tumor originated.


Second-generation TRK inhibitors are currently in development to overcome the acquired resistance mutations in the first generation.


Zai Lab has a launched phase II clinical trial of TPX-0005 (repotrectinib) in China which was acquired from Turning Point Therapeutics in July 2020. TL118, a highly selective NTRK inhibitor developed by Telegene, has already been approved for a phase I clinical study in 2019.


  First CDK4/6 inhibitor for myelosuppression


CDK4/6 inhibitor Cosela (trilaciclib) has finally entered the Chinese market. Co-developed by Chinese firm Simcere and G1 Therapeutics, it was successfully in getting FDA approval in February 2021.


Before Cosela, three CDK4/6 inhibitors had been successfully approved in China, namely Pfizer's Ibrance (palbociclib), Eli Lilly's Verzenio (abemaciclib) and Hengrui's AiRuiKang (dalpiciclib).


Unlike other CDK4/6 inhibitors that focus on HR+/HER2- breast cancer, Cosela is the first drug developed to decrease the incidence of chemotherapy-induced myelosuppression of extensive-stage small cell lung cancer.


Pfizer's Ibrance failed to significantly extend lives in frontline breast cancer, as shown at the ASCO 2022 annual meeting. Therefore, other CDK46 inhibitors need to find new outlets.


Simcere also partnered with G1 to jointly conduct phase III clinical trials of Cosela in other solid tumors as colorectal cancer and triple negative breast cancer.


Notable filings


July also saw a few other notable NDA submissions that are worth keeping an eye on.


Bristol-Myers Squibb filed its NDA submission for BMS-986165 (deucravacitinib) for the treatment of plaque psoriasis, which may become the first TYK2 inhibitor worldwide.


Zai Lab’s NDA application for Vyvgart (efgartigimod), a neonatal Fc receptor (FcRn) antibody fragment for the treatment of generalized myasthenia gravis (MG), was also accepted by the CDE last month.


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Keywords: oncology drugs TRK inhibitor CDK4/6 inhibitor
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