Breast cancer | AstraZeneca/Daiichi Sankyo ADC therapy proposed for priority review
On April 24, the CDE official website announced that the marketing application of trastuzumab deruxtecan for injection is planned to be included in priority review for the indication of unresectable or metastatic HER2-positive adult breast cancer patients
.
According to public information, Enhertu is an antibody-conjugated drug (ADC) targeting HER2 jointly developed by AstraZeneca and Daiichi Sankyo, which has been approved for marketing overseas
.
Not long ago, the drug was included in the breakthrough therapy category in China
.
The clinical development of Enhertu is characterized by wide coverage and deep mining.
On the one hand, it covers HER2-positive breast cancer, HER2-low-expressing breast cancer and even beyond breast cancer.
The next step is gastric cancer (GC) and non-small cell lung cancer (NSCLC).
and colorectal cancer (CRC); on the other hand, in terms of therapy types, from 3-line, 2-line to 1-line and adjuvant/neoadjuvant therapy
.
Insomnia disorder | Class 1 new drug introduced by Jingxin Pharmaceutical submitted a marketing application
On April 24, the CDE official website announced that Jingxin Pharmaceutical had submitted a marketing application for the Class 1 new drug Andacini Capsules, which was accepted
.
According to the public information of Jingxin Pharmaceutical, Andacini Capsules (also known as EVT201 Capsules) is a partial positive allosteric modulator of GABAA receptors introduced by the company for the treatment of insomnia disorders
.
This is Jingxin Pharmaceutical's first small molecule innovative drug marketing application
.
Andacini capsule is a partial positive allosteric modulator targeting gamma-aminobutyric acid A (GABAA) receptors for the treatment of insomnia disorders
.
According to Jingxin Pharmaceutical, compared with the full activator of GABAA receptors, Andacini produces a lower maximum activation potency for GABAA receptors.
This mechanism of action enables the drug to both stimulate GABAA receptors Activation, and rapid inhibition of the nervous system, but also to avoid excessive activation of GABAA receptors, resulting in deep inhibition and neurological side effects
.
At present, Jingxin Pharmaceutical has completed the Phase III clinical trial of Andacini in China and achieved the primary and secondary endpoints.
EVOTEC has also completed the Phase II clinical trial of the drug overseas
.
Ulcerative colitis | Unknown Jun acquires UC drug candidate M201
On April 26, Unknown Jun announced that the company had acquired the clinical-stage M201 project from Assembly Biosciences
.
The M201 project is designed for patients with mild to moderate ulcerative colitis.
It is a formula based on the screening and design of human cell in vitro models and animal models of the disease based on the biological mechanisms and cellular regulatory mechanisms related to ulcerative colitis.
Bacterial drugs
.
It is reported that Unknown Jun has built an "AI+BT" platform that combines artificial intelligence, bioinformatics analysis and intestinal microecological technology to achieve "dry and wet combination" drug development
.
Its AI platform X-Optim is powered by a fully automated cloud-based computing engine that uses proprietary machine learning algorithms to accelerate microecological drug discovery
.
X-Optim enables drug discovery driven by clinical data through its analytical module, as well as the targeting mechanism-driven drug discovery module
.
The BT platform can further evaluate early-stage drug candidates for rapid validation and targeted optimization
.
Biosimilars | Qilu Pharmaceutical's Aflibercept filed for listing
On April 26, Qilu Pharmaceutical announced that the marketing application of aflibercept intraocular injection solution has been accepted by CDE
.
This is the first aflibercept biosimilar to be declared for marketing in China
.
Biological medicine is one of the important research fields of Qilu Pharma
.
Aflibercept is a VEGF inhibitor developed by Bayer and Regeneron
.
As a fully humanized fusion protein, aflibercept can inhibit vascular proliferation and reduce vascular permeability by inhibiting the signaling pathway mediated by VEGF-A, VEGF-B and placental growth factor (PLGF).
For the treatment of neovascular age-related macular degeneration (wet AMD), retinal vein occlusion, diabetic macular edema, visual impairment caused by pathological myopic choroidal neovascularization,
etc.
