21 Jianxun Daily | THE FDA will restrict Johnson & Johnson COVID-19 vaccination; Hengrui Pharmaceutical has appointed a new general manager

Source丨21st Century Business Herald

Editor 丨Xu Xu

Here is 21 Health News Daily! Welcome to pay attention to the latest events in the pharmaceutical and health industry with the new health team of 21st Century Business Herald!

Policy trends

●The Drug Review Center of the State Food and Drug Administration issued two guiding principles

On May 5, the Drug Review Center of the State Food and Drug Administration issued the "Guidelines for Clinical Research and Development of New Drugs for Chinese Medicine Compound Preparations Based on Human Experience (Trial)" and "Guiding Principles for Communication and Exchange Based on the "Three Combinations" Registration Review Evidence System (Trial Implementation)" (No. 24 [2022]).

In order to promote the construction of a Chinese medicine registration review evidence system that combines the theory of traditional Chinese medicine, human experience and clinical trials, under the deployment of the State Drug Administration, the Drug Review Center organized the formulation of the "Guidelines for Clinical Research and Development of New Drugs of Compound Preparations of Traditional Chinese Medicines Based on Human Experience (Trial)" and "Guiding Principles for Communication and Exchange Based on the "Three Combinations" Registration Review Evidence System (Trial)" (see Annex). According to the requirements of the Notice of the General Department of the State Food and Drug Administration on printing and distributing the Procedures for the Issuance of The Technical Guiding Principles for Drugs (No. 9 [2020] of the State Food and Drug Administration), it is hereby promulgated and shall come into force on the date of promulgation.

Approval of pharmaceutical devices

●AbbVie JAK inhibitors expanded indications approved by the FDA

AbbVie announced that the US FDA approved its JAK inhibitor Rinvoq (upadacitinib, uppatinib) to expand the indication for the treatment of adult patients with active ankylosing spondylitis. These patients are intolerant to one or more tumor necrosis factor (TNF) blockers or do not receive an adequate response. The press release notes that this is the fifth indication Rinvoq has acquired in the field of chronic immune-related diseases.

●AstraZeneca/First Three Heavy ADC Extended Indications approved by the FDA

On the 5th, the OFFICIAL WEBSITE OF THE FDA shows that the FDA has approved the expansion of the antibody conjugated drug (ADC) enhertu (ADC) jointly developed by AstraZeneca and the first third party for the treatment of patients with unresectable or metastatic HER2-positive breast cancer, who have received an anti-HER2-targeted therapy.

capital market

●Yunkang Group is expected to be listed on the Hong Kong Stock Exchange on the 18th

Yunkang Group (02325.HK) was listed on the Hong Kong Stock Exchange from May 5 to May 11 and is expected to be listed on the Hong Kong Stock Exchange on May 18. CMB International and SPDB International are their joint sponsors. Yunkang Group plans to offer 138.1888 million shares, of which 90% are for international offerings, 10% for public offerings and 15% for over-allotment rights. The offer price per share was HK$7.89, raising approximately HK$1,090 million.

Founded in 2008, Yunkang Group is a medical operation service provider that mainly provides a full range of diagnostic testing services for medical institutions. According to the Frost & Sullivan Report, Yunkang Group is the fifth largest company in China's medical operation service market with a market share of 3.7% in terms of revenue in 2020; the fifth largest provider in China's diagnostic outsourcing service market with a market share of 3.0%; and the second largest provider of diagnostic testing services for China's jointly built medical institutions, with a market share of 12.5%.

●Juzi Bio submitted an IPO application in Hong Kong

According to the disclosure of the Hong Kong Stock Exchange on May 5, Juzi Bio submitted a listing application to the main board of the Hong Kong Stock Exchange, with Goldman Sachs and CICC as joint sponsors.

Juzi Bio is a pioneer and leader in China's professional skin care products industry based on bioactive ingredients. The company designs, develops and manufactures specialized skin care products with recombinant collagen as the key bioactive ingredient. The company also develops and produces functional foods based on rare ginsenoside technology. Using proprietary synthetic biology technology, the company independently develops and produces several types of recombinant gum proteins and rare ginsenosides. With many years of R&D experience in bioactive ingredients and an integrated business model, the company is an industry leader in technology and markets.

According to Frost & Sullivan, the company is the second largest professional skin care product company in China in 2021 (in terms of retail sales), and has been the largest collagen professional skin care product company in China (in terms of retail sales) for three consecutive years from 2019; the company's recombinant collagen flagship brands, Klargin and Kefumei, respectively, are the third and fourth best-selling brands (in terms of retail sales) in China's professional skin care products industry in 2021.

Industry events

●Hengrui Pharmaceutical appointed a new general manager

On the 5th, Hengrui issued an announcement that according to the needs of business development, Mr. Dai Hongbin was appointed as the general manager of the company by the nomination of Mr. Sun Piaoyang, the chairman of the board, and the term of office was from the date of deliberation and approval of the board of directors to the expiration of the term of the current board of directors. Dai Hongbin has joined Hengrui since graduating from university and has been around for 22 years. Since July 2000, he has served as the director of the office and the secretary of the board of directors, and has been the deputy general manager of the company since April 2013 and the director and deputy general manager of the company since January 2020.

● Zhang Fangliang, former chairman of Jinsrui, was not prosecuted by the prosecution

Recently, Jin Sirui issued an announcement that Zhang Fangliang, a former director of the company, a former chairman and former CEO, a former director of Legendary Bio, and a former chairman and former CEO, was not prosecuted by the procuratorate, and the company, its subsidiaries and related individuals will not bear any criminal liability for the investigation; in addition, Zhang Fangliang was appointed as a non-executive director of the company, effective from May 2.

●The FDA announced that it will limit Johnson & Johnson COVID-19 vaccination

The U.S. Food and Drug Administration (FDA) announced on May 5 local time that due to the risk of thrombosis after vaccination, the vaccination of Johnson & Johnson's new crown vaccine will be restricted, and only people who cannot or do not want to receive other new crown vaccines will be allowed to receive Johnson & Johnson vaccine.