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Hengrui's Class 1 New Drug Fluzoparib has been Applied for New Clinical Trials

February 03, 2020 By Caicai

Hengrui has been the hotspot of the medical world recently. According to an announcement of Hengrui Medicine previously, Sun Piaoyang will step down as the chairman of Hengrui, however, he will continue to serve as a director and the chairman of the strategic committee under the Board of Directors of the company; Zhou Yunshu who has served as the general manager for 17 years will serve as the chairman of the new session of the Board of Directors.

The Company, the Board of Directors and its members undertake that the information disclosed does not contain any false statement, misrepresentation or major omission and they are jointly and severally liable for the authenticity, accuracy and integrity thereof.

Hengrui's Class 1 New Drug Fluzoparib has been Applied for New Clinical Trials

The 1st Meeting of the 8th Board of Directors of Jiangsu Hengrui Medicine Co., Ltd. was held in the form of an on-site meeting in Shanghai on Jan. 16, 2020. 9 directors should attend this meeting and 9 directors were present. All the directors thoroughly reviewed and passed the following proposals:

I. Proposal on Electing the Chairman of the 8th Board of Directors of the Company

Electing Mr. Zhou Yunshu as the Chairman of the 8th Board of Directors of the Company

Consent: 9 votes        Objection: 0 vote        Abstention: 0 vote

After this meeting, Mr. Sun Piaoyang will serve as a director and the chairman of the strategic committee of the Company and no longer serve as the Chairman of the Board of Directors. Mr. Sun Piaoyang has led Hengrui to achieve sustainable and healthy development for 30 years. The Board of Directors of the Company expresses gratitude and pays high respect to Mr. Sun Piaoyang’s remarkable contributions and hard work for the development of Hengrui.

II. Proposal on Amending the Detailed Working Rules of the Strategic Committee

Sun Piaoyang is definitely a leading figure of Hengrui Medicine, who has led Hengrui to develop from a small pharmaceutical factory in northern Suzhou to the leader of Chinese pharmaceutical enterprises. According to the annual report, Hengrui achieved operating income of RMB17.418 billion in 2018, growing by 25.89% year on year, with the net profits attributable to the owners of the parent company of RMB4.066 billion, growing by 26.39% year on year. Hengrui’s market cap exceeded RMB400 billion in 2019, and it is called the “leader in R&D” and “leader in market cap” of China’s pharmaceutical industry.

Despite Sun Piaoyang’s leaving office, I believe that Hengrui, the pharmaceutical leader in China, will not stop moving forward and will launch more blockbuster drugs in the future.

Fluzoparib expected to be the 7th in addition to the 6 Class 1 innovative drugs approved

Hengrui has so far 6 Class 1 new drugs approved, including 4 chemical drugs and 2 biological drugs, separately: imrecoxib, apatinib, mecapegfilgrastim (19K), pyrotinib, remimazolam, and camrelizumab. Fluzoparib is currently Hengrui’s only drug at the “application for marketing” stage, with the marketing application filed to the NMPA in Oct. 2019 and the indication being a third-line treatment of recurrent ovarian cancer.

PARP is currently one of the top 10 hot targets of new drugs in the world, and fluzoparib is a PARP inhibitor. 4 PARP inhibitors are marketed in the world at present; wherein, olaparib and niraparib have been approved for marketing in China. Olaparib was approved for marketing in China in Aug. 2018 to become the first small molecule PARP inhibitor in China; Zai Lab’s niraparib was also approved for marketing in China in Dec. 2019. The global market size of PARP inhibitors was around USD1 billion in 2018, and olaparib accounted for more than half thereof.

Pharmaceutical product name

Trade name

Company

Approved indication

Olaparib

Lynparza

AstraZeneca

BRCA-mutated advanced ovarian cancer (third-line); epithelial ovarian, fallopian tube or primary peritoneal cancer (second-line);

BRCA-mutated HER2-negative metastatic breast cancer; pancreatic cancer (orphan drug); platinum-sensitive recurrent ovarian cancer (approved in Mainland China in Aug. 2018)

Rucaparib

Rubraca

Clovis

gBRCA-mutated ovarian cancer (third-line); ovarian, fallopian tube or primary peritoneal cancer

Niraparib

Zejula

GSK, Zai Lab

Recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer; platinum-sensitive recurrent high-grade serous epithelial ovarian cancer (Hong Kong); platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (approved in Mainland China in Dec. 2019)

Talazoparib

Talzenna

Medivation, Pfizer

BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer

 (Source: FDA, NMPA)

Hengrui’s Class 1 new drug fluzoparib was applied for new clinical trials on Jan. 17, with the indication, according to my prediction, possibly phase III clinical trial of treating prostatic cancer or phase II clinical trial of treating other indications.

Acceptance No.

Pharmaceutical product name

Pharmaceutical product type

Application type

Registration classification

Enterprise name

Undertaking date

CXHL2000015

Fluzoparib Capsules

Chemical drug

New drug

1

Jiangsu Hengrui Medicine Co., Ltd., Jiangsu Hengrui Medicine Co., Ltd.

Jan. 17, 2020

CXHL2000017

Fluzoparib Capsules

Chemical drug

New drug

1

Jiangsu Hengrui Medicine Co., Ltd., Jiangsu Hengrui Medicine Co., Ltd.

Jan. 17, 2020

CXHL2000016

Fluzoparib Capsules

Chemical drug

New drug

1

Jiangsu Hengrui Medicine Co., Ltd., Jiangsu Hengrui Medicine Co., Ltd.

Jan. 17, 2020

Upon query on the Drug Clinical Trial Registration and Information Publicity Platform, fluzoparib involves a total of 17 clinical trials, with 5 completed and 12 underway. From the perspective of the indication layout, indications of fluzoparib that Hengrui conducts clinical trials for include small cell lung cancer, prostatic cancer, ovarian cancer, advanced gastric cancer, and recurrent metastatic triple-negative breast cancer, etc. Wherein, the second-line treatment of metastatic castration-resistant prostate cancer is in phase II, and the second-line treatment of recurrent or metastatic gastric cancer and small cell lung cancer, etc. is in phase I.

From the perspective of the clinical trial layout, Hengrui Medicine continues its consistent style: laying out multiple indications of the same products to expand potential target populations of products and improve the market competitiveness thereof. Please refer to “Hengrui’s Class 1 New Drug in Development: Fluzoparib Approved for New Clinical Trials to Compete in China’s PARP Inhibitor Market” for more information.

Fluzoparib and camrelizumab are definitely the two products Hengrui is focusing on the layout of at present, which I will pay constant attention to.

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