China Market Approval Tracker: Apr 2021
Minhua Chu ·2 months ago
China NMPA Approval Tracker


Writer: Minhua Chu

Editor: Justin Fischer


This past April, the NMPA expanded three PD-1/PD-L1 antibodies already marketed in China to key patient populations.


Toripalimab (Touyi), an anti-PD-1 antibody developed by Junshi was approved for the treatment of locally advanced or metastatic urothelial cancer that has progression within 12 months of administering platinum-based chemotherapy, regardless of PD-L1 expression. This is the third indication after 2L melanoma and 3L nasopharyngeal carcinoma (NPC).


On February 28, 2021, Junshi and AstraZeneca China announced a strategic collaboration. AstraZeneca acquired the communalization rights for toripalimab in non-core markets in Mainland China and exclusive communalization rights in the indication of urothelial cancer. AstraZeneca will therefore oversee the marketing of this newly approved indication.


Camrelizumab (AiRuiKa), another anti-PD-1 antibody developed by Chinese company Hengrui, was approved as a therapy for 3L or higher-line NPC.


Roche’s anti-PD-L1 antibody, atezolizumab (Tecentriq), got its third approval for 1L PD-L1-positive, EGFR/ALK-negative metastatic non-small cell lung cancer (NSCLC) patients.


Three potential blockbuster drugs from multinational companies also got first market approvals in China. They are dimethyl fumarate (Tecfidera) from Biogen; semaglutide (Ozempic) from Novo Nordisk, a once-weekly agonist of glucagon-like peptide-1 (GLP-1) receptors; and new influenza (flu) antiviral drug baloxavir marboxil (Xofluza) from Roche.


The NMPA also gave the green light to two orphan drugs, Takeda obtained them by acquiring Shire. Icatibant (Firazyr) for hereditary angioedema (HAE) and velaglucerase alfa (Vpriv) for Gaucher disease. HAE and Gaucher disease are both listed on China's First National List of Rare Diseases issued in 2018. The New Drug Applications (NDAs) are on the List of Overseas New Drugs Urgently Needed in Clinical Settings, allowing them to be submitted directly with faster review periods and waiver of requirements for Chinese clinical trials.



Hua Medicine announced that the marketing application for dorzagliatin, a first-in-class (FIC) diabetes drug, was accepted by the NMPA in April. Dorzagliatin, bought from Roche, is the world's first glucokinase activator (GKA) submitted for marketing and is expected to be the first to be marketed.


GKA had been the hot target for many pharma giants to develop. However, the drugs from MSD and AstraZeneca failed in phase trials due to a lack of sustainability in efficacy. Safety issues such as a risk of hypoglycemia, fatty liver induction and dyslipidaemia led some scientists to believe that GKA may not be suitable as a type 2 diabetes therapy.


This application is based on the results of the DAWN (HMM0302) study. In December 2020, Hua Medicine announced that the two Phase III 53-week registration trials in over 1,200 Chinese type 2 diabetes patients were successfully completed. Patients who failed glycemic control were dosed with dorzagliatin in both 24-week and 52-week periods with maximum doses of metformin (1500mg/day). At the end of the 24-week period, the primary efficacy endpoint was a 1.02% HbA1c reduction in the dorzagliatin-treated group, together with excellent 5.45 mmol/L reduction of post-meal glucose (2h-PPG) from baseline. These results are statistically significant over a placebo with p-value less than 0.0001. The drug demonstrated that it was safe and well tolerated in the trial.


The marketing applications of two in-licensed drugs from US biopharmaceutical companies were also submitted by their Chinese partners.


OT-401 (flonase vitreous implant) a treatment for chronic non-infectious uveitis. The application is based on data from a real-world study. OcuMension acquired the drug from EyePoint Pharmaceutical.


The other product, PI3K kinase inhibitor duvelisib (Copiktra), was in-licensed by CSPC from Verasterm Oncology in 2018.





Keywords: China Market Approval Tracker NMPA PD-1/PD-L1 Toripalimab (Touyi) Junshi Camrelizumab (AiRuiKa) AstraZeneca Roche EGFR/ALK dimethyl fumarate (Tecfidera) semaglutide(Ozempic)
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