There were 167 varieties of Class 1 new drugs applied in China in the first half of this year, involving 129 pharmaceutical enterprises and research institutions. According to Insight database, 29 pharmaceutical enterprises applied for more than 2 new drug varieties, wherein, Hengrui Medicine topped with a total of 6 applications for Class 1 new drug varieties.

2 Class 1 new drugs applied for production

Hengrui Medicine had 2 Class 1 new drug varieties applied for production in the first half of 2018, separately, Class 1 new chemical drug: remimazolam tosylate and its preparation, and Class 1 biological product for treatment: camrelizumab for injection, with the former being the first Class 1 new drug applied for production in China this year.

Remimazolam tosylate

The marketing application for the Class 1 new drug remimazolam tosylate accepted by CDE on March 21 includes two acceptance numbers: CXHS1800001 (API) and CXHS1800002 (injection). This drug in development belongs to benzodiazepines, and is a short-acting GABAa receptor agonist that is applicable to the intravenous general anaesthesia in selective operations.

Remimazolam tosylate and its preparation were included in the list of the 28^th batch of registration applications of pharmaceutical products to be included in the priority review procedure published by CDE on April 23 upon "having significant therapeutic advantages over existing treatment means", and are now "under review and approval". The industry is generally optimistic about the future market of remimazolam tosylate and considers the drug to have the potential to become a RMB 1 billion/2 billion blockbuster variety.

Camrelizumab for injection

Camrelizumab for injection is a humanized anti-PD-1 monoclonal antibody that is applicable to the treatment of relapsed/refractory classical Hodgkin lymphoma patients who have received at least second-line systemic therapies. This monoclonal antibody in development was also included in the list of the 28^th batch of registration applications of pharmaceutical products to be included in the priority review procedure published by CDE together with remimazolam tosylate, and is currently "under review and approval" on SDA (State Drug Administration of China, formerly CFDA) publicity platform.

The imported anti-PD-1 monoclonal antibody, namely, BMS’ Opdivo, has been approved for marketing in China, which is the first and only anti-PD-L1/PD-1 monoclonal antibody product marketed in China. According to IMS data, Opdivo achieved global sales of USD 5.3 billion in 2017. From the perspective of current treatment trend, anti-PD-1 monoclonal antibody drugs are possible to become the standard treatment of most cancers in the future and may serve as the reinforcement therapy in addition to existing therapies, which breeds huge incremental market space.

Following Opdivo, other anti-PD-L1/PD-1 monoclonal antibody products that have been registered and applied for production in China also include 1 imported product and 3 Chinese-produced products, all of which have been included in CDE’s priority review procedure. The competition has apparently become very intense in this market segment in China. It’s worth continuously watching which will be the first to be marketed among the first echelon of Chinese-produced products.

4 Class 1 new drugs applied for clinical trials

The 4 Class 1 new drug varieties applied for clinical trials are all biological product for treatment. According to the information of SDA’s publicity platform, the Multiple Antigen Specific Cell Therapy (MASCT) Injection is now "under review and approval", while the other 3 have been completed approval.

MASCT Injection

MASCT Injection depends on the Multiple Antigen Specific Cell Therapy which is similar to the TIL (tumor-infiltrating lymphocyte) therapy in the immunotherapy, however, the former has the advantage that it is indicated for more patients, with low possibility of tumor escape that accompanies immune clearance of tumor cells. According to industry speculation, this injection may be used for the treatment of primary hepatocellular carcinoma. No further disclosure of information has been made so far.

SHR-1209 for Injection

The clinical trial application for SHR-1209 for Injection of Hengrui Medicine was accepted by CDE on March 5, which is the 4^th anti-PCSK9 monoclonal antibody applied for clinical trial in China. And according to the latest news, this drug in development has been approved for clinical trial, however, Hengrui Medicine has not released relevant announcement on SHR-1209.

Besides Hengrui Medicine’s SHR-1209 for Injection, other anti-PCSK9 monoclonal antibody drugs that have entered clinical stage in China are separately Junshi Biosciences’ JS002 Injection, Innovent Biologics’ BI306 Injection, and AD Pharmaceuticals’ AK102 Injection; all those 3 products in development are at Phase I clinical trial.

SHR-1603 Injection

The clinical trial application for SHR-1603 Injection was accepted by CDE on January 31, which is designed for the treatment of a malignant tumor, and there is no product in clinical trial with the similar target as it in China. There is not much public information about this drug in development, which may be an anti-LAG3 monoclonal antibody according to industry speculation. This drug in development has been approved for clinical trial, with approval No.: 2018L02559.

SHR-1701 Injection

The clinical trial application for SHR-1701 Injection was accepted by CDE on February 8; according to the latest news, this application has been completed approval by SDA, and the drug in development has been approved for clinical trial. Hengrui Medicine has not released relevant announcement on SHR-1701 Injection, which may be an anti-TIM3 antibody according to industry speculation.

-----------------------------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.