CPhI Pharma Online (5.24-5.28)

This week, Renfu Medicine's Propofol Disodium Phosphate for Injection was officially approved for marketing, which aroused industry attention, and Renfu Medicine's position in the anesthesia industry was further consolidated
.

This week’s review includes 4 sections of review, R&D, trading, and listing.

Review

NMPA

Listed

1.
On May 24, NMPA issued an approval document, and Renfu Pharmaceutical's Class 1 new drug propofol disodium for injection (R&D code HX0507) was approved for marketing
.

The launch of this product will further stabilize Renfu Pharmaceutical's position in the field of anesthesia

2.
On May 24, the official website of NMPA showed that axitinib tablets submitted by Shandong New Times under Category 4 had been approved for marketing , becoming the first imitation of the product
.

Axitinib is a kinase inhibitor that can inhibit tyrosine kinases associated with pathological angiogenesis, tumor growth and cancer progression, vascular endothelial growth factor receptors VEGFR-1, VEGFR-2 and VEGFR-3 at therapeutic doses

3.
On May 27, the official website of NMPA showed that Betta Pharmaceuticals’ new indications for postoperative adjuvant treatment of icotinib (acceptance number: CXHS2000030) have been changed to "under review" and will be approved in the near future.
, Becoming the third approved indication for icotinib
.

4.
On May 27, the listing application for the class 1 antibacterial drug Contazolamide tablets jointly declared by Mengke Medicine and Zhejiang Huahai Pharmaceutical Co.
, Ltd.
entered the approval status (acceptance number: CXHS1900044), and it is expected to be approved soon for skin and soft tissue infections.
Treatment
.

This will be Mengke's first commercialized Class 1 new drug

       clinical

       5.
On May 24, CDE's official website showed that BeiGene's first-in-class HPK1 inhibitor BGB-15025 capsule clinical application was officially accepted for the treatment of solid tumors
.

HPK1 is an immunomodulation-related protein whose main function is to negatively regulate the activation of T cell receptor pathways and inhibit T cell proliferation.

       6.
On May 25, CSPC issued an announcement that SYHX1903 was approved for clinical trials in China
.

SYHX1903 is a highly selective CDK9 inhibitor

       Priority review

       7.
On May 24, the CDE official website announced that Takeda's new oral small molecule drug Mobocertinib capsules will be included in the priority review and publicity will begin
.

The declared indications for marketing are: treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients who have received chemotherapy in the past and carry epidermal growth factor receptor (EGFR) exon 20 (Exon20) insertion mutations

       8.
On May 26, the CDE official website revealed that Bayer's Larotrectinib capsules and oral liquid listing applications are planned to be included in the priority review and begin to be publicized
.

Indications are: treatment of adult and pediatric patients with solid tumors carrying neurotrophic tyrosine receptor kinase (NTRK) fusion gene, these patients have locally advanced, metastatic disease or surgical resection may lead to serious complications or unsatisfactory treatment plan

       9.
On May 27, the official website of CDE showed that the PI3Kδ selective inhibitor Linpris tablets (code name: YY-20394) jointly developed by Yingli Pharmaceuticals and Hengrui had obtained the proposed priority review qualification for Treatment of relapsed/refractory follicular lymphoma
.
Limpris is a category 1 innovative drug independently developed by Yingli Pharmaceutical
.

       FDA

       10.
On May 24, Kangfang Bio-Bio announced that its PD-1 monoclonal antibody , Paimrizumab, co-developed with China Biopharmaceuticals, has initiated the submission of a biological product license application to the US FDA , and its indication is the third-line treatment of metastatic nose.
Pharyngeal cancer
.
The BLA will be reviewed under the new real-time tumor review (RTOR) policy
.
Pianprizumab is the first drug included in RTOR in China
.

       11.
On May 24, Boehringer Ingelheim announced that the FDA granted BI425809 a breakthrough therapy designation for the treatment of schizophrenia-related cognitive impairment (CIAS)
.
BI425809 tablet is a Gly-T1 inhibitor, designed to increase synaptic glycine levels by inhibiting Gly-T1, thereby enhancing glutamatergic neurotransmission and downstream neuroplasticity processes, and play a therapeutic role
.

       12.
On May 24, Verastem Oncology announced that the FDA granted the RAF/MEK inhibitor VS-6766 and FAK inhibitor Defactinib combination therapy to treat recurrent low-grade serous ovarian cancer (LGSOC) breakthrough therapy qualification
.
VS-6766 is a new dual inhibitor of the RAF/MEK signaling pathway, which can vertically inhibit the RAS pathway as a single agent
.

       13.
On May 25, CSPC announced that NBL-015 was approved for clinical trials in the United States
.
NBL-015 is a fully human anti-Claudin 18.
2 monoclonal antibody for the treatment of advanced solid tumors with positive expression of Claudin 18.
2, including pancreatic cancer, stomach, esophagus or esophageal gastric junction adenocarcinoma
.

       14.
On May 27, GenScript announced that its non-wholly-owned subsidiary Legendary Bio-targeting BCMA CAR-T therapy Cidacchi Oronza (cilta-cel) has been granted priority review by the FDA for its biological product license application for CAR-T therapy.
Qualified for the treatment of patients with relapsed and/or refractory multiple myeloma
.
According to the Prescription Drug User Fees Act (PDUFA), the FDA will complete its review of the BLA by November 29, 2021
.

       other

       15, May 24, Green Leaf Pharmaceutical announced that its independent research and development of innovative formulations of rivastigmine transdermal patch for several days the listing application has successfully passed the review of the EU decentralized procedure
.
Since the end of the review on May 21, 2021, the product has been eligible for marketing authorization in multiple participating member states of the European Union
.
The preparation is used to treat mild and moderate dementia related to Alzheimer's disease
.

R&D

       16.
On May 24, NGM announced the data of a phase IIb clinical study code-named ALPINE2/3, which aims to evaluate the treatment of Aldafermin in the treatment of non-alcoholic steatohepatitis (NASH) with stage II or III liver fibrosis (F2/ F3) The curative effect of the patient
.
The results showed that the study did not reach the primary endpoint of the patient's liver fibrosis improvement ≥ 1 stage and NASH did not worsen at the 24th week
.

       17.
On May 25, Lunsheng Pharmaceutical and Nabriva announced that the Phase III bridging trial of Lefamulin (pleuromutilin acetate) in China for the treatment of adult community-acquired bacterial pneumonia (CABP) has achieved positive results
.
Lefamulin was originally developed by Nabriva.
In March 2018, Lunsheng Pharmaceutical obtained the right to develop and commercialize lefamulin in Greater China
.

transaction

       18.
On May 26, AstraZeneca China announced that it has obtained the exclusive marketing rights of Boian Biologics' anti-tumor biologic drug Boyounuo® (bevacizumab injection) in 21 provinces, cities, and autonomous regions in mainland China.

.
The two parties will combine their respective advantages and resources in the field of market coverage and drug development to promote the expansion of anti-tumor biological drugs to the county market.

Listed

       19.
On May 25, Nanjing Novartis Biotechnology's initial application was approved by the Shanghai Stock Exchange Listing Committee, and it will be listed on the SSE Science and Technology Innovation Board
.
According to the prospectus, Novartis’s current main business is functional protein and polymer organic materials such as enzymes, antigens, and antibodies for technology research and development and product development.
The research and development of new crown neutralizing antibody drugs is ongoing, and it is preparing to enter preclinical research.
Stage
.

       20.
On May 26, Jiangsu Yahong Pharmaceutical Technology submitted an application for listing on the Science and Technology Innovation Board at the Shanghai Stock Exchange and was accepted
.
Jiangsu Yahong Pharmaceutical is a global innovative drug company that is about to enter the commercialization stage, focusing on urogenital system (Urogenital System) tumors and other major diseases.
Currently, there is no product on the market
.