Since 2021, these 12 local Chinese new drug applications have been included in the priority review!

4.

Growth hormone is a peptide hormone secreted by the anterior pituitary gland of the human body, which can promote the growth of bones, internal organs and the whole body
.
In January 2021, CDE accepted an application for the marketing of new indications of recombinant human growth hormone for injection by Anke Biologics for idiopathic short stature, and included it in the priority review.
New varieties, dosage forms and specifications of drugs"
.

According to Anke Biology’s announcement, previously, its recombinant human growth hormone for injection has been approved in China to treat multiple indications, including slow growth in children caused by endogenous growth hormone deficiency and Noonan syndrome.
Children with short stature, children with short stature or growth disorder caused by SHOX gene defects, severe burn treatment, children with short stature caused by achondroplasia, adult short bowel syndrome with nutritional support
.

5.
Kaimao Bio: Human Interferon γ for Injection Mechanism: γ-IFN Indications: Rheumatoid Arthritis, Liver Fibrosis, Chronic Granulomatous Disease, etc.

Human interferon (IFN) gamma for injection was developed by Shanghai Kaimao Biomedicine Co.
, Ltd.
and belongs to the 2.
2 new drugs
.
Interferon γ has a strong immune regulation function, can enhance the function of antigen presenting cells, accelerate the clearance of immune complexes and improve the function of phagocytosis of foreign bodies, and has a two-way regulation function on lymphocytes
.

In March 2021, CDE included the drug’s marketing application for priority review on the grounds that "clinically urgently needed drugs, innovative drugs and improved new drugs for the prevention and treatment of major infectious diseases and rare diseases"
.
The indications of the drug in this application are: rheumatoid arthritis, liver fibrosis, chronic granulomatous disease, and Mendelian hereditary mycobacterial susceptibility diseases
.

6.
Fuhong Hanlius: Slulimab Mechanism of Action: Anti-PD-1 mAb Indication: MSI-H solid tumor

Si Luli monoclonal antibody (HLX10) is a complex macro Hanlin development of a anti-PD-1 monoclonal antibody, to be developed for the treatment of solid tumors, chronic hepatitis
.
In April 2021, CDE accepted the listing application of slulimumab and included it in the priority review
.
The indication for this application of the drug is: for the treatment of unresectable or metastatic MSI-H solid tumors that have failed standard treatments
.

According to a press release issued by Fuhong Hanli in March 2021, in a pivotal phase 2 clinical study of patients with unresectable or metastatic MSI-H solid tumors who failed standard treatment, luliimab demonstrated It achieved good efficacy and safety, and reached the main research endpoint
.

7.
Hengrui Medicine: SHR6390 Tablets Mechanism of Action: CDK 4/6 Inhibitor Indication: Breast Cancer

SHR6390 is an oral, highly effective and selective small molecule CDK 4/6 inhibitor developed by Hengrui Medicine
.
The drug can selectively inhibit the activity of CDK 4/6 kinase, thereby blocking the CDK 4/6-Rb signaling pathway, inducing cell G1 blockade, and selectively inhibiting the proliferation of tumor cells with high Rb expression, thereby achieving resistance The role of tumors
.

In April 2021, CDE accepted the listing application of SHR6390 film and included it in priority review
.
The indication for this application of the drug is: combined with fulvestrant for hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) recurrent or metastatic breast cancer that has progressed after endocrine therapy Treatment
.
The results of a phase 3 clinical study showed that for patients with HR+ and HER2- advanced breast cancer who have previously received endocrine therapy, compared with placebo combined with fulvestrant, receiving SHR6390 combined with fulvestrant can significantly prolong the patient’s absence.
Progressive survival
.

8.
Howson Pharmaceuticals: Ametinib Mesylate Tablets Mechanism of Action: Third-generation EGFR-TKI Indication: Non-Small Cell Lung Cancer

Ametinib is a third-generation EGFR (epidermal growth factor receptor)-TKI (tyrosine kinase inhibitor) developed by Hausen Pharmaceuticals
.
In March 2020, the drug was approved for marketing by NMPA for the first time for the treatment of locally advanced or metastatic NSCLC patients who have been treated with EGFR-TKI and have a T790M mutation
.

In May 2021, CDE accepted the listing application for new indications of Ametinib and included it in the priority review
.
The indication for this application of the drug is: the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation
.
According to a press release issued by Hausen Pharmaceuticals, in the phase 3 study of the first-line treatment of EGFR mutation-positive locally advanced or metastatic NSCLC, ametinib has achieved positive results and reached the preset primary research endpoint
.

9.
Yingli Pharmaceutical: Linpris Tablets Mechanism of Action: PI3Kδ Inhibitor Indication: Follicular Lymphoma

Linperlisib (YY-20394) is a new generation of PI3Kδ (phosphatidylinositol 3-kinase subtype δ) highly selective inhibitor developed by Yingli Pharmaceutical
.
In May 2021, CDE accepted the listing application of Limpuli Division and included it in the priority review
.
The indication for this application of the drug is: for the treatment of patients with relapsed or refractory follicular lymphoma who have previously received second-line or above systemic treatment
.

In a phase 2 registered clinical trial, linprilsi has shown significant efficacy in the treatment of patients with relapsed/refractory follicular lymphoma: in 89 evaluable patients, linpril has reached more than 80% Objective remission rate, and disease control rate of more than 95%; In addition, oral administration of linpril is safe, controllable and well tolerated
.

10.
Hualan Biology: Quadrivalent Influenza Virus Split Vaccine

Indications: Influenza

Public information shows that the quadrivalent influenza virus split vaccine developed by Hualan Biotechnology contains four influenza virus antigen components: A H1N1, A H3N2, B Yamagata (By), and B Victoria (Bv)
.
Previously, the vaccine has been approved in China for vaccination of people over 3 years old
.

In May 2021, Hualan Biotechnology submitted a new indication marketing application for a quadrivalent influenza virus split vaccine, and was included in the priority review due to "vaccines and innovative vaccines urgently needed for disease prevention and control"
.
According to the information published by CDE, the specification of the quadrivalent influenza virus split vaccine this application is "0.
25ml per tube, 0.
25ml per human dose (for people under 6 months to 3 years old), containing various types of influenza viruses The hemagglutinin of the strain should be 7.
5μg", which is intended to be used for the prevention of influenza caused by related types of influenza viruses for people 6 months to 3 years old
.

11.
BeiGene: Tilelizumab Injection Mechanism of Action: Anti-PD-1 mAb Indication: MSI-H or dMMR solid tumor

Tilelizumab is a humanized lgG4 anti-PD-1 monoclonal antibody developed by BeiGene.
The drug has been approved for 5 indications in China, involving squamous NSCLC, non-squamous NSCLC, and classic Hodgkin's lymphoma, urothelial carcinoma, hepatocellular carcinoma
.
In addition, three new indications for tislelizumab have been accepted by the CDE
.
The 7th indication for tislelizumab is included for priority review.
The application was submitted in June 2021 and is intended to be used for previously treated locally advanced unresectable or metastatic MSI-H or dMMR entities Tumor
.

According to the data previously published by BeiGene: In the main effectiveness analysis set, the ORR of patients based on the results of the Independent Review Committee (IRC) was 45.
9%, the ORR of patients with colorectal cancer was 39.
1%, and the ORR of patients with other tumor types was 57.
1%; 4 patients achieved complete remission (CR); among 34 patients who achieved remission, the median time to remission (TTR) was 10.
5 weeks, and there was no disease progression; median PFS and OS (overall survival) were not At 12 months, the PFS rate and OS rate were 59.
3% and 75.
3%, respectively
.

In addition to the above-mentioned new drugs, since this year, many new drug marketing applications declared by import category have been included in the priority review by CDE.
Due to space limitations, this article will not introduce them one by one
.
It is hoped that these new drugs will be approved as soon as possible and will bring new treatment options to patients
.

Reference materials:

[1] Drug Evaluation Center of China National Medical Products Administration.
Retrieved July 27, 2021, from http://