Challenges and Opportunities With Oncology Drug Development in China

Bajaj, Gaurav; Gupta, Manish; Wang, Hwei‐Gene Heidi; Barrett, Jeffrey S.; Tan, Matthew; Rupalla, Katrin; Bertz, Richard; Sheng, Jennifer

doi:10.1002/cpt.1017

Cited by 22 publications

(31 citation statements)

References 64 publications

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“…Approvals of small molecules in Japan and China have occurred on average 2.3 and 3.3 years after their approvals in the United States, whereas the approval delays of biologics are 2.8 and 4.8 years in Japan and China, respectively. The delays in drug approval remain a potential issue on patient health in China and Japan …”

Section: Drug Approval Delaymentioning

confidence: 99%

“…Biologic drugs, including monoclonal antibodies, are mainly distributed to the blood and basically eliminated by nonspecific immunoglobulin G and specific target‐mediated drug disposition pathways via intracellular catabolism . Their clearances are generally not influenced by the polymorphism of metabolic enzymes and less sensitive to intrinsic ethnic factors.…”

Section: Elimination Pathwaysmentioning

confidence: 99%

“…The lag for Japan was much shorter compared with China because Japan has adapted the International Conference on Harmonization (ICH) E5 guideline (i.e., ethnicsensitivity and bridging concept) earlier, and China just became a new regulatory member of the ICH in 2017. The regulatory reforms in China in recent years (e.g., sponsors can start clinical trials after 60 working days of clinical trial application if there is no action from the NMPA) could significantly reduce review time. When we were finalizing this article, the NMPA released another favorable regulatory policy for potential accelerated approval of orphan drugs with significant unmet medical needs in China by using global clinical study outcomes, with ethnic sensitivity analysis per the ICH guideline.…”

Section: Future Oncology Drug Development In China and Japanmentioning

confidence: 99%

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Oncology Therapy Drugs in China, Japan, and the United States: Pharmacokinetic Characteristics, Dose Regimens, and Development Strategies

Zhou¹,

Higashimori

Shen³

et al. 2019

Clin Pharma and Therapeutics

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The oncology targeted therapy and immunotherapy drugs approved in the United States, Japan, and China were reviewed. No clinically meaningful difference in pharmacokinetic characteristics or in dose regimens was observed among Western, Japanese, and Chinese populations. Integrated global development strategies in China and Japan are proposed, including potential waiver of the phase I pharmacokinetic/ tolerability studies in Asian patients, based on ethnic sensitivity assessment for new oncology drugs.

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Section: Drug Approval Delaymentioning

confidence: 99%

Section: Elimination Pathwaysmentioning

confidence: 99%

Section: Future Oncology Drug Development In China and Japanmentioning

confidence: 99%

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Oncology Therapy Drugs in China, Japan, and the United States: Pharmacokinetic Characteristics, Dose Regimens, and Development Strategies

Zhou¹,

Higashimori

Shen³

et al. 2019

Clin Pharma and Therapeutics

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“…22 Thus, the association of lower body weight with increased exposure and potentially associated safety risks may be more relevant for Chinese patients compared with Western populations. 23 However, the efficacy is not expected to be reduced given higher exposure with flat dosing. 6,8 A pooled PPK analysis of data from global studies showed that the time-averaged steady-state exposure of nivolumab 240 mg was consistent with 3 mg/kg every 2 weeks across multiple tumor types.…”

mentioning

confidence: 99%

Clinical Benefit‐Risk Assessment of Nivolumab 240 mg Every 2 Weeks in Chinese Patients With Advanced and Metastatic Solid Tumors

Sheng

Zhang

Baudelet

et al. 2021

The Journal of Clinical Pharma

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Nivolumab 240 mg every 2 weeks is approved in China by the National Medical Product Agency for squamous cell carcinoma of the head and neck and gastric cancer, based on population pharmacokinetic (PPK) analyses and benefit-risk assessment of safety/efficacy in solid tumors, including Chinese and global populations. The aim of this assessment was to investigate exposure and risk for adverse events (AEs) with flat dosing compared with weight-based dosing. Nivolumab 240-mg and 3-mg/kg every-2-week exposures in Chinese patients were simulated using PPK modeling, and AEs in Chinese and pooled global populations were compared by dosing regimen, exposure, and weight. The 10-mg/kg every-2-week regimen was included because it is known to be well tolerated. Predicted nivolumab exposure in Chinese patients receiving 240 mg every 2 weeks was ∼25% higher versus 3 mg/kg every 2 weeks, but ∼60% lower versus 10 mg/kg every 2 weeks. Grade 3/4 AE incidence in Chinese patients receiving nivolumab 3 mg/kg every 2 weeks was similar with 240-mg every-2-week dosing and with patients from global populations treated with 3 or 10 mg/kg every 2 weeks. There was no trend toward increased AE incidence with high versus low nivolumab exposure or in global patients of varying body weight receiving 3 or 10 mg/kg every 2 weeks. Objective response rates were similar in Chinese and global patients with squamous and nonsquamous NSCLC. Results showed that benefit-risk profiles with nivolumab 240 mg every 2 weeks were similar to those of the 3-mg/kg every-2-week regimen in Chinese patients and global populations, providing an alternative treatment option to Chinese patients.

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“…Besides intrinsic factors, an extrinsic factor resulting in ethnic differences important in China is the culture of using botanical preparations (Bajaj et al 2019). Several preparations used in traditional Chinese medicine (TCM) have been reported to alter enzyme activities in preclinical models and/or in clinical drug-drug interaction studies (Qiu et al 2016;Tang et al 2016).…”

Section: Use Of Pbk Modelling To Study Inter-ethnic Human Kinetic Differencesmentioning

confidence: 99%

Alternative testing strategy to quantify inter-species, inter-ethnic, and inter-individual variation in bioactivation and toxicity of food-borne alkenylbenzenes and pyrrolizidine alkaloids

Ning¹

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China Food and Drug Administration (CFDA) (2006) Regulation on production of herbal tea products China Food and Drug Administration (CFDA) (2013a) List of herbs allowed for health food products (in Chinese) China Food and Drug Administration (CFDA) (2013b) List of dietary herbs (in Chinese) China Food and Drug Administration (CFDA) (2016) Detailed rules for the examination and approval of health food registration (in Chinese)

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Challenges and Opportunities With Oncology Drug Development in China

Cited by 22 publications

References 64 publications

Oncology Therapy Drugs in China, Japan, and the United States: Pharmacokinetic Characteristics, Dose Regimens, and Development Strategies

Oncology Therapy Drugs in China, Japan, and the United States: Pharmacokinetic Characteristics, Dose Regimens, and Development Strategies

Clinical Benefit‐Risk Assessment of Nivolumab 240 mg Every 2 Weeks in Chinese Patients With Advanced and Metastatic Solid Tumors

Alternative testing strategy to quantify inter-species, inter-ethnic, and inter-individual variation in bioactivation and toxicity of food-borne alkenylbenzenes and pyrrolizidine alkaloids

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