-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
◆ There are 209 acceptance numbers of new drugs approved for clinical trial in September, involving 121 varieties (with list)
Data statistics As of September 30, Insight will publish the overview and indications of approved clinical new drugs in the latest month every month, welcome to pay attention to view
.
Data sources for this report: Insight database, CDE website
This month, it was approved for clinical new drugs
This month, it was approved for clinical new drugs According to the Insight database application progress database, a total of 209 clinical new drugs were approved in September 2022, involving 121 varieties.
The following figure shows the specific list of new clinical drugs approved in September:
The following is a description of some of the key products of the clinical varieties approved this month, the article is slightly longer and can be read
selectively.
Introduction of approved new clinical drugs
Introduction of approved new clinical drugs In September, 209 new drugs were approved for clinical acceptance, involving 121 varieties, and some products are introduced as follows
.
Drug Name: BA1106 injection
Name of the drugCompany Name: Boan Biotechnology
Business name BA1106 is an anti-CD25 fully human monoclonal innovative antibody independently developed by Boan Biologics, a holding subsidiary of Luye Pharmaceutical Group, and is also the first similar drug
in China to enter the clinical stage for the treatment of solid tumors.
CD25 is also known as the interleukin-2 receptor α subunit (IL-2Rα), which is highly expressed
in Treg cells.
Preclinical studies have shown that BA1106 has a good therapeutic effect on both early and advanced tumor models, and shows good synergistic effect in combination with anti-PD-1 antibodies.
At the same time, BA1106 does not block the IL-2 signaling pathway and has a moderate, specific killing effect
on Treg cells.
Drug Name: BGC1201 tablets
Name of the drugCompany Name: Borui Pharmaceutical
Business name BGC1201 is a RTK-RAS-MAPK signaling pathway-targeted drug with dual mechanisms of targeting tumor growth and tumor immunity, and is intended to be developed for solid tumors
.
BGC1201 regulates the RAS-ERK signaling pathway and plays an important role
in regulating tumor cell survival and growth.
In addition, the BGC1201 site is downstream of immune checkpoints such as PD-1, mediating tumor immune escape signals
.
Drug Name: BLU-701 tablets, BLU-945 capsules
Name of the drugCompany name: Blueprint Pharmaceutical Company, Zai Lab
Business name BLU-701 and BLU-945, two fourth-generation EGFR inhibitors, derived from Blueprint Pharmaceuticals' proprietary research platform, are designed to comprehensively cover the most common activating and targeted resistant mutations, avoid wild-type EGFR and other kinases to reduce off-target toxicity, and enable a range of combined strategies to treat or prevent central nervous system metastases
.
Zai Lab has previously acquired exclusive development and commercialization rights
to BLU-945 and BLU-701 in Greater China.
BLU-945 is currently conducting a Phase 1/2 SYMPHONY study in patients with treated EGFR-driven non-small cell lung cancer domestically and internationally).
BLU-701 was approved for clinical trial for the first time in Chinese mainland and has progressed to phase 1/2 clinical trials
overseas.
Drug Name: BN301
Name of the drugCompany name: Sutro Biopharma, Yehui Pharmaceutical
Business name BN301 is a well-structured, homogeneous antibody conjugate (ADC) consisting of a human origin, non-glycosylated anti-CD74 IgG1 antibody and two non-cleavable maytanso-linkers, intended for development for hematologic tumors
.
Through a licensing agreement with Sutro Biopharma in October 2021, Yehui Biopharma has been granted the option to exclusively develop and commercialize BN301 in Greater China
.
Sutro is currently in the United States for a Phase I clinical study
of STRO-001.
Drug Name: CAEL-101 Injection
Name of the drugCompany name: Alexion Pharmaceuticals, AstraZeneca
Business name CAEL-101 is a potential first-in-class fiber-reactive monoclonal antibody, which has been approved for clinical development for the first time in mainland China for AL amyloidosis, and has progressed to phase
III overseas.
The drug was acquired
by AstraZeneca's Alexion company through a $500 million acquisition of Caelum Biosciences.
CAEL-101 can bind to misfolded different light chain protein isoforms and amyloid proteins to reduce or eliminate amyloid deposition, thereby improving organ function
in patients.
Drug Name: GH55 capsules
Name of the drugCompany name: Qinhao Pharmaceutical
Business name GH55 is a bimechanism ERK1/2 inhibitor intended to be developed for solid tumors
.
ERK1/2 is an extracellular regulatory protein kinase downstream of the RAS/MAPK signaling pathway involved in cell proliferation and survival
.
。 GH55 inhibits ERK1/2 activation of ERK1/2 by MEK while inhibiting ERK1/2 kinase activity, preventing drug
resistance due to negative feedback modulation.
Drug Name: IBI333
Name of the drugCompany Name: Innovent Biologics
Business name IBI333 is a VEGF-A/VEGF-C bispecific antibody intended to be developed for wet age-related macular degeneration, which is the third bispecific antibody drug
approved by Innovent in the field of ophthalmology.
Drug Name: JNJ-77242113-AAC tablets
Name of the drugCompany Name: Johnson & Johnson
Business name JNJ-77242113-AAC tablet is an oral IL-23 receptor antagonist, which is currently undergoing phase 2 clinical studies overseas, and this time it was approved for the development of psoriasis
.
Janssen & Company entered into a nearly $1 billion partnership with Protagonist Therapeutics to obtain an exclusive global license
for the development and commercialization of the drug.
Drug Name: RY_SW01 Cell injection
Name of the drugCompany Name: Ruiyuan Biotechnology
Business name RY_SW01 Cell Injection is a mesenchymal stem cell drug to be developed for the treatment of lupus nephritis
.
Earlier, the product has completed the first patient administration enrollment in an investigator-initiated clinical trial (IIT), and preliminary results show a good safety profile
.
Name of the drug: Selatogrel injection
Name of the drug Company name: Idorsia Pharmaceuticals, Edoxi (Beijing) Pharmaceutical Co.
, Ltd
Selatogrel is a novel, rapid-acting, patient-owned, reversible P2Y12 receptor antagonist for the pre-admission treatment
of AMI in adults with a history of acute myocardial infarction (AMI).
Phase 3 clinical studies
are currently being conducted overseas for indications for acute myocardial infarction.
Two completed Phase 2 clinical studies have shown rapid and reversible inhibition of platelet aggregation, rapid onset of action within 15 minutes, and intensity of action lasting approximately 8 hours
.
Drug Name: STI-6129 injection
Name of the drugCompany name: Aisen Pharmaceutical
Business name STI-6129 is an antibody conjugate drug targeting CD38 using CD38-specific antibodies screened by Sorrento Therapeutics technology platform and Duostatin 5
, a proprietary small molecule toxin.
Sorrento is currently conducting a Phase 1/2 clinical study in the United States to evaluate the efficacy
of the drug in patients with late relapsed and/or refractory systemic light chain (AL) amyloidosis.
Aisen Pharmaceuticals was previously acquired by Sorrento as a wholly owned subsidiary
.
This time, the STI-6129 injection declared by Aisen Pharmaceutical was approved for clinical trial to develop the treatment of relapsed or refractory multiple myeloma
.
Drug name: Tinlarebant tablets
Name of the drugCompany Name: DoubleBiotechnology
Business name Tinlarebant (LBS-008), a lead candidate for BioBio, is an oral non-tretinoin RBP4 small molecule antagonist that reduces and maintains vitamin A (retinol) delivery to the eye to reduce the accumulation
of toxic vitamin A byproducts in eye tissue.
LBS-008 has been granted Orphan Drug Designation (ODD), Pediatric Rare Disease Designation (RPD), Expedited Review Designation, and ODD
by the EU EMA.
This time, Tinlarebant was approved for clinical trials in China for the treatment of juvenile hereditary macular degeneration disease (Stargardt disease).
Drug Name: XH-5102 tablets
Name of the drugCompany Name: Xunhe Pharmaceutical
Business name XH-5102 is a highly selective JAK2 inhibitor with independent intellectual property rights of Hun Ho Pharmaceutical, intended for the treatment
of myeloproliferative tumors.
In addition, XH-5102 is being studied as a treatment for autoimmune diseases, and other new indications are also well underway
.
Drug Name: ZS801 injection
Name of the drugCompany name: the best and only new
Business name ZS801 is an AAV therapy, independently developed by Best, and the clinical indications approved this time are: control and prevention
of bleeding in men aged 18 years and older with severe and moderate severe B (congenital coagulation factor IX deficiency, coagulation factor IX<2%) 。 Compared with traditional enzyme replacement therapy, the virus in AAV therapy will not integrate into the normal chromosomes in the patient's body, but will persist in the patient's body in an independent free chromosome form, and use amino acids and other raw materials in normal cells to continuously produce coagulation factors for patients, so as to achieve the purpose of radical treatment of hemophilia, so the product is expected to achieve the therapeutic effect
of "one shot cure".
ZS801 is also the first original target gene drug
for hemophilia B in China.
Drug Name: Zirconium [89Zr] Gyllentuximab injection
Name of the drugCompany name: Telix Pharmaceuticals, Grand Pharmaceutical
Business name Zirconium [89Zr] Gyllentuximab injection (TLX250-CDx) is an innovative diagnostic radionuclide conjugate intended for PET-CT imaging
of clear cell renal cell carcinoma.
The product targets carbonic anhydrase IX (CA9),
which is overexpressed in urological malignancies.
Based on its possible breakthrough in the non-invasive diagnosis of ccRCC, the most common and aggressive type of kidney cancer, and in the subsequent treatment and management decisions of patients, TLX250-CDx was granted breakthrough therapy designation by the US FDA in July 2020, and all subjects have been recruited in overseas phase 3 clinical studies, and the study is expected to be completed and reported in
the second half of the year.
