38 new drugs have been approved for clinical use, and both traditional Chinese medicine and biological drugs have exploded!

Guide: A week of new drug clinical trends highlights: 1.
50 new drug applications have obtained the default approval for clinical trials, including 34 new drugs in Category 1.
2.
CDE has newly accepted clinical trial applications for 19 new drugs (28 acceptance numbers) 3 and 2.
1 4.
A number of new anti-tumor drugs of Chia Tai Tianqing have been approved for clinical trials.
According to the data of clinical drug intelligence, 50 new drug applications have obtained the default approval for clinical trials in this period (March 27 to April 2), involving 31 There are 7 domestic new drugs and 7 imported new drugs; another 26 varieties (38 acceptance numbers) clinical applications have been accepted by CDE, and more developments are as follows: New drug clinical applications · Newly approved In this issue, 50 new drug applications have been approved for clinical trials by default Licensed, involving 31 domestic new drugs and 7 imported new drugs
.
The clinically approved innovative drugs include peptide tumor vaccines, multiple double antibodies, PROTACs, new Chinese medicines, etc.
The indications cover tumors, pain, diabetic nephropathy, immune system diseases, insomnia, infectious diseases and a variety of rare diseases
.
1.
3D-189 for injection 3D-189 is a new generation of peptide tumor vaccine targeting WT1 protein introduced by Sidi, which belongs to the first-in-class innovative drug
.
It is reported that the global multi-center pivotal registration phase III clinical trial of 3D-189 monotherapy in patients with acute myeloid leukemia (AML) in second complete remission (CR2) is underway, and the combination with PD-1/PD-L1 monoclonal antibody Phase I/II clinical trials of the combination are also underway
.
This is the first time that 3D-189 has been approved for clinical use in China, and the indication is hematological malignancies
.
2.
ASC60 tablets ASC60 is a potent, selective and safe oral small molecule fatty acid synthase (FASN) inhibitor developed by Ascletis
.
Preclinical mouse tumor model studies have shown that ASC60 can effectively inhibit tumor growth and enhance the tumor suppressive effect of mPD-1 antibody
.
This approval is a phase I clinical trial of ASC60 in the treatment of advanced solid tumors
.
3.
D-1553 Tablets D-1553 is a highly selective KRAS G12C inhibitor under development by Yifang Bio.
It has been approved as a single drug or in combination with other anti-tumor drugs for advanced or metastatic KRAS G12C mutations Sexual solid tumors
.
4.
QR052107B Tablet QR052107B is a P2X3 receptor selective antagonist independently developed by Wuhan Langlai Technology.
It was originally developed for the treatment of refractory and/or unexplained chronic cough
.
The QR052107B was approved by the CDE clinically implied, and the indication is chronic pain
.
5.
ABSK043 Capsules ABSK043 is an innovative oral small molecule PD-L1 inhibitor developed by Heyu Medicine
.
In multiple preclinical models, ABSK043 demonstrated comparable anti-tumor efficacy to approved anti-PD-L1 antibodies
.
This time, the implied permission of the clinical trial was obtained, and the proposed indication is malignant tumor
.
In addition, Heyu Pharma will also explore the potential of this oral small-molecule PD-L1 inhibitor in combination therapy with other drugs
.
6.
TQB3915/TQB2450/TQB2618 TQB3915 tablets are class 1 new anti-tumor drugs developed by Chia Tai Tianqing.
This is the first clinical approval of this variety, and the indications are advanced malignant solid tumors
.
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1) developed by Chia Tai Tianqing
.
TQB2618 is a TIM-3 mAb developed by Chia Tai Tianqing
.
The default approval for this clinical trial is TQB2450 combined with TQB2618 injection for the treatment of advanced malignant solid tumors
.
7.
AC682 Capsule AC682 Capsule is an estrogen receptor alpha (ERα) degrader developed by Bingzhou Stone Biotechnology based on the AI ​​drug discovery platform.
It is an orally bioavailable chimeric degradation molecule (PROTAC)
.
This time, it was approved by the CDE for clinical development, and the indication is ER+/HER2- locally advanced or metastatic breast cancer
.
At present, in addition to AC682 capsules, three PROTAC drugs from Haisco, Kintor and BeiGene have been approved for clinical trials in China
.
8.
QL1604/QL1706 Injection QL1706 is a PD-1/CTLA-4 dual antibody of Qilu Pharmaceuticals, approved in combination with lenvatinib mesylate capsules for the treatment of adult patients with advanced renal cell carcinoma
.
QL1604, a PD-1 monoclonal antibody from Qilu Pharmaceuticals, was approved in combination with paclitaxel and cisplatin/carboplatin ± bevacizumab for patients with recurrent or metastatic cervical cancer who have not received systemic therapy before
.
9.
YK012 for injection YK012 is a CD3/CD19 bispecific antibody developed by Yikesite based on the FIST platform, with the potential of Best-in-class or First-in-class
.
The indications for which YK012 has been granted the default approval of the clinical trial are relapsed/refractory B-cell non-Hodgkin lymphoma
.
10.
BC004 for injection BC004 is a recombinant anti-HER2/CD3 bispecific antibody developed by Luzhou Buchang Biology.
The indications that have obtained the default approval for this clinical trial are for the treatment of HER2-positive advanced solid tumors, including HER2-positive breast cancer.
, gastric cancer/gastroesophageal junction adenocarcinoma,
etc.
11.
SKB264/KL-A167 for injection SKB264 is a TROP2-ADC developed by Lunbotai, a subsidiary of Sichuan Kelun Pharmaceutical Co.
, Ltd.
It is currently conducting phase II clinical trials in China and the United States for multiple tumor types, including non-small cell lung cancer
.
KL-A167 is a PD-L1 monoclonal antibody developed by Kelun Biotech.
In November 2021, the first application for marketing authorization of KL-A167 injection for nasopharyngeal carcinoma was submitted, and it is currently under review and approval
.
The clinical default approval granted this time is a Phase II clinical study of SKB264 in combination with KL-A167 (PD-L1 monoclonal antibody) with or without platinum in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC)
.
12.
IBI321/IBI319/IBI323 Innovent Bio has obtained clinical approval for multiple dual antibodies, including IBI321, IBI319, and IBI323
.
IBI321 is a dual antibody targeting PD-1/TIGIT, IBI323 is a dual antibody targeting LAG-3/PD-L1, IBI319 is a new generation dual antibody targeting PD-1/CD137, 3 new drugs The indications to be developed are all advanced malignant tumors
.
13.
BC008 Antibody Injection BC008 is an antibody drug developed by Baochuan Biology, a subsidiary company of Guilin Sanjin Holdings, for the treatment of CLDN18.
2 positive advanced solid tumors
.
14.
Ruiji Orenxai Injection Seriji Orenxai Injection is a self-developed product of WuXi Ju Nuo on the basis of the CAR-T cell technology platform of Ju Nuo Medical, a subsidiary of Bristol-Myers Squibb (BMS).
Autologous CAR-T cell immunotherapy products targeting CD19
.
The drug has previously been approved in China for the third-line treatment of patients with relapsed or refractory large B-cell lymphoma
.
This approval is a Phase 3 clinical trial for the second-line treatment of large B-cell lymphoma
.
15.
Zaobai Anshen Granule Zaobai Anshen Granule is a new type 1 traditional Chinese medicine drug declared by Jiangsu Kangyuan Pharmaceutical
.
Indications: Nourishes blood and calms the soul, clears heat and eliminates vexation
.
It is used for insomnia due to deficiency of liver blood and internal disturbance of deficiency heat, symptoms of deficiency, irritability, insomnia, or difficulty falling asleep, or restless sleep at night, or even sleepless night; often accompanied by: heat in hands, feet, night sweats, dry mouth and less fluid Forgetfulness, tinnitus, palpitations, restless embolism, red tongue with little coating, rapid pulse
.
For chronic insomnia, see the above syndromes
.
16.
Pomegranate flower suppository Pomegranate flower suppository is a class 1 new traditional Chinese medicine declared by the Uyghur Medicine Research Institute of Xinjiang Uygur Autonomous Region
.
For vulvovaginal candidiasis (increased leucorrhea), simple; symptoms include increased leucorrhea, yellow color, thick texture, genital itching, dysuria,
etc.
In this issue, CDE has newly accepted clinical applications for 26 new drugs (38 acceptance numbers)
.
Among them, 20 varieties (27 acceptance numbers) are domestic new drugs, and 6 varieties (11 acceptance numbers) are imported new drugs.
More developments are as follows: Data sources: Yaozhi data, corporate announcements and other online public data Sources of information: Pharmaceuticals Internet public information such as Zhiwang and corporate announcements