CPhI Pharma Online (4.26-4.30)

As a big country with diabetes, Novo Nordisk's star diabetes drug simeglutide officially entered China this week
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This week’s review includes four sections: review, R&D, listing, and trading.

Review

NMPA

Listed

1.
On April 23, Hua Medicine announced that the company's first innovative drug for diabetes, Dorzagliatin, had submitted its NDA application and was accepted by the CDE
.
Dozaglietin has become the first glucokinase activator (GKA) diabetes treatment drug in the world to submit a new drug marketing application, and it is expected to become the first global innovative drug (FIC) to be marketed in China

2.
On April 23, the official website of NMPA showed that the marketing application for influenza drug Mabaloxavir (trade name: Xofluza) submitted by Roche in China (acceptance number: JXHS2000074/5) is in the "under review" stage and is expected to be It has recently been approved for listing in China
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Mabaloxavir is a First-in-Class oral antiviral drug that can be effective after one dose.

3.
On April 27, the official website of NMPA showed that Yichang Renfu Pharmaceutical’s 3-category generic midazolam oral solution was approved for marketing, becoming the first midazolam oral solution in China, which is suitable for pediatric patients in diagnosis and Sedation, anti-anxiety and amnesia before treatment, endoscopic surgery or before induction of anesthesia
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The product has not yet been listed in China.

4.
On April 27, the NMPA official website showed that the new indication of Roche PD-L1 atelizumab was approved for marketing.
The single drug is used for PD-L1-positive and EGFR/ALK-negative metastatic non-small cell lung cancer (NSCLC).
) First-line treatment for patients
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Atelizumab was first approved in China in February 2020.

5.
On April 27, the official website of NMPA showed that the application for the new indication for Darzalex injection (Darzalex) submitted by Xi'an Janssen in China (acceptance number: JXSS2000019/20) has been approved
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The indications are: combined with lenalidomide and dexamethasone or combined with bortezomib and dexamethasone to treat adult patients with multiple myeloma who have received at least first-line treatment in the past.

6.
On April 29, the official website of NMPA showed that Henri Carrelizumab was approved for marketing in the new indication for use in patients with advanced nasopharyngeal carcinoma who had advanced or intolerable disease after receiving second-line or above chemotherapy
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Among the domestically approved PD-1s, only Hengrui and Junshi have reported on the market for nasopharyngeal cancer indications, including third-line and first-line treatments for nasopharyngeal cancer

       7.
On April 29, Novo Nordisk announced that NMPA officially approved the launch of smegaglutide injection (0.
5mg, 1mg pre-filled injection pen, trade name: Novotel) to assist diet and exercise to improve Type 2 Blood glucose control in patients with diabetes (T2DM)
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Smeglutide is a long-acting glucagon-like peptide-1 receptor (GLP-1R) agonist, which only needs to be injected subcutaneously once a week

       clinical

       8.
On April 26, the official website of CDE showed that Hengrui first publicized the new drug SHR-1707 for the Phase I clinical trial of Alzheimer's disease, and the clinical trial was granted implied permission on March 11 this year
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According to Hengrui’s previous announcement, SHR-1707 injection can prevent the assembly of β-amyloid plaques or activate microglia to engulf various forms of Aβ, thereby reducing the level of Aβ in the brain of AD patients and ultimately delaying patient cognition Function degradation and control disease progression
.

       FDA

       9.
On April 23, ADC Therapeutics announced that the FDA has accelerated the approval of its CD19-targeted ADC drug Zynlonta.
The single-agent therapy has been relapsed or refractory (r/r) diffuse after receiving at least 2-line and above systemic treatment before.
Adult patients with large B-cell lymphoma (DLBCL), including non-specific types of DLBCL, DLBCL caused by poorly differentiated lymphoma, and DLBCL caused by well-differentiated B-cell lymphoma
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This is the first and only CD19-targeted ADC drug approved for the treatment of DLBCL
.

       10.
On April 28, Calliditas announced that the NDA of its Nefecon (Budesonide Sustained Release Capsule) has been accepted by the FDA for the treatment of IgA nephropathy
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The FDA also granted priority review qualification for the drug, and the PDUFA date is September 15, 2021
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Nefecon is expected to be the first drug to be approved by the FDA for the treatment of IgAN
.

       11.
On April 28, Takeda announced that the U.
S.
FDA has granted priority review for its new drug application for the treatment of Mobocertinib (TAK-788) for the treatment of metastatic non-small cell lung cancer with positive EGFR exon 20 insertion ( NSCLC) adult patients
.
These patients had previously received platinum-containing chemotherapy
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Mobocertinib is the first oral therapy specifically designed to selectively target EGFR exon 20 insertion
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       R&D

       12.
On April 23, Eli Lilly China announced that the Phase III clinical study (RHBH) evaluating ichizumab (trade name: TuoZi) for Chinese adults with moderate to severe psoriasis has been successfully completed.
The main research data is in It was successfully published at the American AAD conference that day, and the study reached two common primary endpoints and all key secondary endpoints
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Ichilizumab was included in the first batch of clinically needed overseas new drugs in 2018 and was approved by the NMPA in August 2019 for the treatment of moderate to severe plaque psoriasis in adults
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       13.
On April 23, Bristol-Myers Squibb announced the positive results of two key Phase III clinical studies of its first-in-class oral, selective TYK2 inhibitor Deucravacitinib in the treatment of moderate to severe plaque psoriasis
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Both the POETYKPSO-1 and POETYKPSO-2 studies reached the common primary endpoint, and Deucravacitinib was well tolerated, with a lower rate of discontinuation due to adverse events (AEs)
.

       14.
On April 23, Avillion published the Phase II clinical results of its tri-specific nanobody Sonelokimab (M1095) in plaque psoriasis online on the "Lancet".
All primary and secondary endpoints were Reach
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Sonelokimab is an investigational trispecific half-life extension Nanobody, which is believed to neutralize IL-17A and IL-17F, and has the potential to treat inflammatory diseases
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Due to their small size and unique structure, nanobodies are expected to develop into a new generation of new biological drugs
.

       15.
On April 28, BeiGene announced that the BTK inhibitor Zebutinib versus ibrutinib was used in the treatment of adult relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma The head-to-head global phase 3 clinical trial of (SLL) patients achieved positive results in the interim analysis, reaching the primary efficacy and safety-related secondary endpoints
.

       16.
On April 28th, Galera Therapeutics announced that the investigational therapy GC4419 has obtained positive results in a phase 1/2 clinical trial for the treatment of locally advanced pancreatic cancer patients
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The test results showed that GC4419 combined with stereotactic radiotherapy (SBRT), compared with SBRT, increased the patient's median overall survival (OS) by nearly double
.

       Listed

       17.
On April 26, the Hong Kong Stock Exchange disclosed that Advaccine had submitted an IPO prospectus
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Ai Di Weixin is a high-tech enterprise focusing on innovative vaccines.
Ai Di Weixin’s pipeline of products under development includes the new coronavirus DNA vaccine, respiratory syncytial virus (RSV) vaccine, hepatitis B therapeutic vaccine, and a number of cancer vaccines.
and so on
.

       18.
On April 29, Zhaoke Ophthalmology went public on the Hong Kong Stock Exchange
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The company has raised nearly 2 billion Hong Kong dollars from the IPO, making it the 32nd innovative drug company to successfully go public after the Hong Kong Stock Exchange’s 18A New Deal
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Zhaoke Ophthalmology was established in January 2017.
Its main business is the research, development and commercialization of ophthalmic drugs and therapies
.

       transaction

       19.
On April 27, Huadong Medicine announced that it would acquire 75% of Zhejiang Daoer Biotech's shares for RMB 487.
5 million and become its controlling shareholder
.
After the completion of the transaction, Huadong Medicine became its largest shareholder
.
DowBio was established on April 1, 2014, focusing on the development of multi-domain-based multispecific innovative fusion proteins, antibody drugs and peptide drugs to meet unmet clinical needs in the fields of oncology, metabolism, and ophthalmology
.

       20.
On April 28, Pfizer announced that it has acquired the private company Amplyx Pharmaceuticals.
The company's lead compound is an antifungal drug candidate Fosmanogepix (APX001).
Pfizer will further expand Pfizer's business in the field of anti-infection
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The specific terms of the acquisition were not disclosed
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Fosmanogepix is ​​a first-line drug being developed by Amplyx for the treatment of invasive fungal infections, including highly resistant Candida aureus and Candida aureus
.