CSPC's 2 bio-pharmaceuticals have been clinically approved, and domestically produced hepatitis B class 1 new drugs are coming!

Highlights:

24 new drug applications have been granted default approval for clinical trials, including 14 domestically produced Class 1 new drugs

CDE newly accepted clinical trial applications for 23 new drugs (29 acceptance numbers)

Zhengda Tianqing's new drug for chronic hepatitis B has been approved for clinical use!

A variety of double antibodies have been approved for clinical use!

Yaozhi data shows that in this issue (August 20 to August 27), 24 new drugs have been approved for clinical trials (31 acceptance numbers); 17 domestic new drugs and 7 imported new drugs are involved.

New Drug Clinical Application·Newly Approved

In this issue, 24 new drugs (31 acceptance numbers) have been implicitly approved for clinical trials, including 14 domestically produced Class 1 new drugs

Data source: Yaozhi data

1.

BPI-23314 has been approved for a number of clinical trials, including single-drug use for malignant hematological tumors (acute myeloid leukemia, non-Hodgkin’s lymphoma and multiple myeloma), advanced malignant solid tumors and the approved Malignant hematological tumors, including but not limited to myeloproliferative tumors such as myelofibrosis and myelodysplastic syndromes

2.

Two clinical trials were approved this time: (1) SHR-1701 combined with standard chemotherapy for perioperative treatment of resectable gastric cancer or gastroesophageal junction cancer; (2) Combined chemotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma Treatment

3.

4.

5.

PB-119 is modified by PEGylation on the basis of Exenatide, which can prolong the half-life of the drug, and finally achieve subcutaneous injection once a week to control blood glucose levels steadily and effectively

6.

EN002 is a new target DNA replication initiation protein (DRIPs) inhibitor pioneered by Enkang Pharmaceutical, and is the company's first new generation of anti-tumor drugs independently developed based on source innovation
.
The clinical indications approved this time are non-melanoma skin cancer and precancerous lesions
.

7.
Zorifertinib tablets

The class 1 new drug zorifertinib tablets declared by Chentai Medicine has obtained the implied license of clinical trials, and it is planned to be developed for the treatment of non-small cell lung cancer (NSCLC)
.
Zorifertinib (AZD-3759) was originally developed by AstraZeneca and later by the licensed Chentai Pharmaceutical
.
Data show that zorifertinib is a new-generation EGFR-TKI drug with a blood-brain barrier penetration rate of up to 100%.
It is currently undergoing phase 2/3 clinical studies in patients with EGFR mutation-positive NSCLC with CNS metastasis
.

8.
TQA3605 tablets

The clinical trial application of Zhengda Tianqing TQA3605 tablets was approved by the Food and Drug Administration, and it is proposed to treat chronic hepatitis B as a single drug or a combination of nucleoside (acid) drugs
.
China is a major liver disease country.
Starting in the 1980s, CP Tianqing began to focus on the research and development of liver disease drugs, and successively launched a new class of drugs Tianqing Luscious, antiviral drugs Runzhong, Qingzhong and other more than 10 liver disease products
.
There are currently many innovative hepatitis B drugs in the clinical research stage
.

9.
IMM01 for injection

IMM01 for injection is a new generation of immune checkpoint inhibitor with independent intellectual property rights developed based on ImmuneOnco’s “mAb-Trap” technology platform.
It targets the immune regulatory target CD47.
By activating the phagocytosis of macrophages on tumor cells, And present the phagocytosed tumor antigen to T cells, thus exerting a powerful tumor immunotherapy effect
.
IMM01 solves the core pain points of CD47 target drug research and development, and has been granted invention patents in China, Japan and the United States
.
The clinical indication approved this time is CD20-positive B-cell non-Hodgkin's lymphoma
.

10.
EX101 injection

EX101 is a dual antibody targeting HER2/CD3, and it is also the second CD3 target dual antibody to enter the clinical stage.
The approved indication is advanced malignant solid tumor
.
Last month, another dual antibody EX103 (targeting CD20/CD3) from Elsemi was approved for clinical use, and a phase I clinical study for CD20-positive non-Hodgkin's lymphoma is currently underway
.

11.
Recombinant anti-PD-1 fully human monoclonal antibody injection

The new indication for PD-1 of CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co.
, Ltd.
, a subsidiary of CSPC, has been approved for clinical use in the treatment of recurrent or metastatic head and neck squamous cell carcinoma
.
Previously, CSPC PD-1 was also approved for clinical trials for recurrent or metastatic nasopharyngeal cancer and ovarian cancer
.

12.
Recombinant humanized anti-epidermal growth factor receptor monoclonal antibody injection

Shanghai Jinmante EGFR monoclonal antibody, a subsidiary of CSPC, was approved for clinical use, and its indication is recurrent or metastatic head and neck squamous cell carcinoma
.
EGFR protein is a protein on the surface of cells in the body, produced by the expression of EGFR gene, commonly known as "epidermal growth factor receptor", and is closely related to the growth of epidermal cells
.
When the EFGR gene is mutated, it will express EGFR protein frantically, leading to excessive epidermal growth factor receptors on the cell membrane surface, accelerating the abnormal growth and division of cells, and ultimately leading to tumors
.
EGFR monoclonal antibody achieves therapeutic effects by inhibiting the expression of EGFR protein
.

13.
SMET12 for injection

The CD3/EGFR dual antibody "SMET12 for injection" of Shimai Pharmaceuticals was approved for clinical use, and its indication is advanced solid tumors with high EGFR expression
.
On the one hand, SMET12 targets EGFR, which can inhibit the expression of EGFR protein; on the other hand, it targets CD3 antigen, which can concentrate T cells to tumor cells, activate T cells to kill tumor cells and achieve dual anti-tumor effects
.

14.
IBI110

Innovent's IBI110 treatment of small cell lung cancer (SCLC) was approved for clinical trials
.
IBI110 is a monoclonal antibody that targets the lymphocyte activation gene 3 protein (LAG-3.
also known as CD223)
.
The Chinese name of LAG-3 is lymphocyte activation gene-3.
It is a member of the immunoglobulin superfamily and is closely related to CD4.
It can be selectively expressed on the surface of activated T cells, NK cells and other immune cells, and is related to tumors and tuberculosis.
And other related diseases
.
The target drug has not yet been marketed worldwide, but there are already many projects under development
.

15.
AK104 injection

AK104 injection is the first double antibody product independently developed by Kangfang Biologics using its Tetrabody double antibody platform.
It is also the world's first PD-1/CTLA-4 double specific antibody to enter clinical trials
.
AK104 injection has been approved to carry out a number of clinical trials in China.
The approved indication is gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
.
On August 23, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved a new drug application for Cadonilimab (AK104 injection) for the treatment of recurrent or metastatic cervical cancer, and given priority review qualifications, which is expected to become a domestic The first domestically produced double antibody product
.

16.
Initumab for injection

The combination plan of Sansheng Guojian HER2 monoclonal antibody Saiputin® (Initumumab) and ImmuneOnco CD47 fusion protein IMM01 has obtained the implied approval of the clinical trial of the State Food and Drug Administration, and will start a treatment for HER2+ entities Phase Ib/II clinical trials of tumor patients
.
Inituzumab is a biosimilar of Roche trastuzumab and the first domestic HER2 monoclonal antibody
.
In June 2020, Initumab was approved by the NMPA for the treatment of HER2-positive metastatic breast cancer in combination with chemotherapy; it was included in the National Medical Insurance List through negotiations at the end of the year
.
Sansheng Guojian is carrying out a number of clinical trials, evaluating the combination with other innovative drugs, and intends to expand the clinical indications of initumab
.

17.
LNP023 capsule

LNP023 is an oral, specific "first-in-class" complement factor B inhibitor developed by Novartis, which can block intravascular and intervascular hemolysis by targeting complement instead of signaling pathways
.
Currently, this innovative therapy is used in clinical trials to treat paroxysmal nocturnal hemoglobinuria (PNH), idiopathic membranous nephropathy, IgA nephropathy, primary IgA nephropathy, and the approved C3 nephropathy.
Ball disease
.

18.
ATG-010 piece

The Phase II clinical study of Celiniso® (XPOVIO®) in the treatment of myelofibrosis (MF) was approved by the National Medical Products Administration
.
Kayseri nisoldipine kind is first and only oral type selective inhibitor of nuclear export (the SINE) compound by Karyopharm Therapeutics Inc.
developed
.
Deck Pharmaceuticals has obtained the exclusive development and commercialization rights of Celiniso in a number of Asia-Pacific markets including Greater China, South Korea, Australia, New Zealand and ASEAN countries, and has obtained priority approval for new drug listing applications in South Korea
.
Previously, Celiniso has been approved in the United States, Israel, the European Union and South Korea for the treatment of refractory and relapsed multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL); the follow-up will be From the fourth quarter of 2021 to the first quarter of 2022, it will be approved for listing in multiple Asia-Pacific markets
.

19.
Nipocalimab injection

The first class new drug nipocalimab injection declared by Janssen, a subsidiary of Johnson & Johnson, has been approved for a clinical trial for the treatment of systemic myasthenia gravis (gMG)
.
Nipocalimab is an IgG1 antibody that binds to FcRn developed by Momenta
.
In August 2020, Johnson & Johnson acquired Momenta for approximately US$6.
5 billion and obtained R&D pipeline projects including the latter’s main product nipocalimab
.

20.
HBM9161 (HL161BKN) injection

Bartolizumab (HBM9161) is a fully human monoclonal antibody that targets the neonatal Fc receptor (FcRn) developed by HanAll Biopharma.
In 2018, Hebobo Medicine obtained the drug in the Greater China region (including China, Hong Kong, Macau and Taiwan) have the right to develop, produce and commercialize
.
Prior to this, bartolizumab has been approved to carry out a number of clinical studies in China, and this time it has been approved for a new indication: chronic inflammatory demyelinating polyneuropathy (CIDP)
.

21.
enfortumab vedotin for injection

Astellas enfortumab vedotin for injection was approved clinically, and the indication is combined with pembrolizumab for the perioperative treatment of patients with myometrial invasive bladder cancer who can tolerate cisplatin therapy
.
Enfortumab vedotin is an antibody-conjugated drug (ADC) that can accurately target cancer cells through enfortumab, and cause cancer cell cycle arrest and apoptosis through MMAE
.

22.
Pembrolizumab Injection

Merck’s PD-1 monoclonal antibody pembrolizumab injection has been approved for clinical use and is intended to be used for the treatment of muscular invasive bladder cancer
.

New Drug Clinical Application·New Acceptance

In this issue, CDE has newly accepted clinical applications for 23 new drugs (29 acceptance numbers)
.
Among them, 17 varieties (23 acceptance numbers) are domestic new drugs, and 6 varieties (6 acceptance numbers) are imported new drugs.
More developments are as follows:

Source: Yaozhi Data