CPhI Pharma Online (4.19-4.23)

Several blockbuster drugs have made new progress this week.
Hengrui’s CDK4/6 inhibitor Dalpiciclib submitted its marketing application and was included in the priority review; Novo Nordisk’s megglutide will be approved soon, and the domestic long-acting GLP-1 market will Usher in strong competitors
.

Review

NMPA

Listed

1.
On April 19, the NMPA official website showed that Novo Nordisk's Semaglutide injection (0.
5mg, 1mg prefilled injection pen) listing application (acceptance number JXSS2000006, JXSS2000007) has been "pending approval" Stage
.

2.
On April 19, the CDE official website showed that Yangtze River's 4 generic drug Regofinil tablets were declared for listing (acceptance number: CYHS2101075), which was the first generic drug to be listed on the market in China
.

3.
On April 20, the official website of NMPA showed that the new indication of Hengrui Carrelizumab for Injection (Registration Classification: 2.
2) Marketing Application (Acceptance Number: CXSS2000045) has been "under review" and is expected to be approved in the near future It is marketed for the treatment of advanced nasopharyngeal carcinoma patients who have previously received second-line or above chemotherapy and whose disease has progressed or become intolerable
.

       4.
On April 20, the official website of NMPA showed that the review status of the new indication of Roche atelizumab (acceptance number: JXSS2000033) was changed to "under approval", or it will be approved in the near future
.

       5.
On April 21, the official website of CDE showed that the listing application of Duvelisib Capsule (Duvelisib) of CSPC was formally accepted, and it is planned to be included in the priority review for the treatment of relapse or refractory that has undergone at least two systemic treatments in the past.
Follicular lymphoma (FL)
.

       6.
On April 21, the listing application for trastuzumab injection (subcutaneous injection) submitted by Roche was undertaken by CDE
.

       7.
On April 22, the NMPA official website showed that the listing application for varenicline tartrate tablets (acceptance number: CYHS2000128/9) filed by Hausen Pharmaceuticals according to Registration Classification 4 (acceptance number: CYHS2000128/9) is in the "under review" stage and will be approved by NMPA in the near future After listing, it will be the first imitation of this product in China
.

       8.
On April 22, the CDE official website showed that Roche submitted a listing application for trastuzumab subcutaneous injection.
Trastuzumab subcutaneous injection is Roche anti-Her2 monoclonal antibody trastuzumab and Halozyme is based on the Enhanze technology platform A compound preparation composed of recombinant human hyaluronidase PH20 (rHuPH20, a kind of endoglycosidase) developed by subcutaneous injection
.
The product was approved by the FDA in February 2019 for the treatment of Her2-positive early breast cancer
.

       clinical

       9.
On April 20, Hengrui issued an announcement stating that SHR-1314 injection has been approved for clinical use, and clinical trials for adult lupus nephritis will be launched in the near future
.
SHR-1314 injection, or Vunakizumab, is a recombinant humanized monoclonal antibody targeting human IL-17A independently developed by Hengrui, which is intended to be used to treat autoimmune diseases related to the IL-17 pathway
.
This is the third clinical trial approved for the drug.
At present, Hengrui has launched 9 clinical trials for the drug, the highest being in Phase II clinical trials
.

       Priority review

       10.
On April 21, the official website of CDE showed that Hengrui's CDK4/6 inhibitor Dalpiciclib (SHR6390 tablets) has been accepted and will be included in priority review.
The indication is combined with Fulvestrant for hormone receptor (HR) Treatment of recurrent or metastatic breast cancer that is positive and human epidermal growth factor receptor 2 (HER2) negative has progressed after endocrine therapy
.

       11.
On April 22, Henlius announced that the listing application of its recombinant anti-PD-1 humanized monoclonal antibody slulimumab (HLX10) has been officially accepted and announced that it will be included in the priority review and approval.
For patients with unresectable or metastatic highly microsatellite unstable (MSI-H) solid tumors that have failed standard treatment
.

       FDA

       12.
On April 17, Chipset Biosciences announced that Chiauranib has been clinically approved by the US FDA for the treatment of relapsed/refractory small cell lung cancer (SCLC).
The company will start the treatment of SCLC 1b in the United States.
Phase 2 clinical trial
.
Chiauranib (Chiauranib/CS2164) is a new chemical structure independently designed and developed by Microchip Biosciences with global patent protection.
It is a multi-target multi-pathway selective kinase inhibitor and a small molecule anti-tumor original innovative drug.

       13.
On April 19, Amgen announced that the US FDA granted its first-inclass monoclonal antibody Bemarituzumab breakthrough therapy designation, combined with modified FOLFOX6 chemotherapy regimens (leucovorin, fluorouracil, and oxaliplatin), as the first-line treatment for FGFR2b.
Expression and HER2-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) adenocarcinoma
.

       14.
On April 23, the US FDA announced that it has accelerated the approval of the anti-PD-1 antibody Jemperli (Dostarlimab) developed by GSK to treat patients with relapsed or advanced endometrial cancer
.
These patients progressed after receiving platinum-containing chemotherapy and carried abnormal characteristics of DNA repair called mismatch repair defects (dMMR)
.

       R&D

       15.
On April 20, Adagio Therapeutics announced that it has completed a $336 million Series C financing led by RA Capital Management
.
This funding will support the continued development of the neutralizing antibody therapy ADG20
.
ADG20 is the main candidate monoclonal antibody for the treatment and prevention of COVID-19 and potential future coronaviruses
.

       16.
On April 22, Junshi Biopharmaceuticals issued an announcement that the phase III clinical study of teriprizumab combined with paclitaxel/cisplatin in the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma reached the main research endpoint and plans to communicate and submit a marketing application in the near future
.
The JUPITER-06 study is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study, which aims to compare teriprizumab combined with paclitaxel/cisplatin and placebo combined with paclitaxel/cisplatin in the advanced stage or metastasis Efficacy and safety of first-line treatment for esophageal squamous cell carcinoma
.

       transaction

       17.
On April 19th, Sino-US Huadong, a wholly-owned subsidiary of Huadong Medicine, signed a strategic cooperation agreement with Norlin Biomedical Technology, to deepen its layout in the ADC field
.
Nuo Ling Biological was established in October 2015, focusing on the research and development of a new generation of ADC drugs with independent intellectual property rights
.
The new generation of ADC uses polymer conjugates, which can solve the problems of unstable coupling of traditional ADC drugs, easy toxin shedding, and large toxic side effects
.

       18.
On April 22, Ningbo Manova issued an announcement stating that it has signed a ten-year strategic cooperation agreement with Merck’s subsidiary Interway.
The two parties have decided to jointly establish a long-term and stable cooperation in the fields of pet medicine, veterinary medicine, and animal health.
Customized development and production (CDMO) partnership
.

       19.
On April 23, Triastek, a 3D printing drug company in China, announced the establishment of product development and commercialization cooperation with Sperogenix Therapeutics, which focuses on the R&D and commercialization of rare disease drugs in China.
Patients with pulmonary hypertension (PAH) jointly develop an improved new drug product T22
.

       Performance

       20.
On April 19, Hengrui announced its 2020 annual report.
The annual operating income was 27.
735 billion yuan, a year-on-year increase of 19.
09%; the net profit attributable to shareholders of listed companies was 6.
328 billion yuan, a simultaneous increase of 18.
78%; R&D expenses were 4.
989 billion yuan.
A year-on-year increase of 28.
04%, accounting for 17.
99% of operating income
.