Baiyunshan's cash flow has increased by 9 times, and the joint mining price of the eight provinces has been cut by more than 90%.

Unnamed medicines face the risk of being terminated from the market; Innovent PD-1 was refused approval by the FDA.
.
.
What "drugs" are worthy of attention in the pharmaceutical circle this week? The editor has sorted it out, let's take a look together!

Policy at a Glance

State Food and Drug Administration: The drug quality management system extends to the origin of Chinese medicinal materials

On March 25, on the official website of the State Food and Drug Administration, the "Six Unifications" of the quality control of Chinese herbal medicine manufacturers, Chinese herbal medicine manufacturers should strengthen quality management, and GAP guide the production and supervision of Chinese herbal medicines.

Policy diagram

State Food and Drug Administration: Retail distribution needs to ensure physical separation of drugs and non-drugs

On March 22, the General Department of the State Food and Drug Administration publicly solicited opinions on the "Quality Management Practice for Pharmaceuticals - Appendices on Quality Management of Pharmaceutical Retail Distribution (Draft)"
.

This heavy document clearly states that if non-drugs (except medical equipment and health food) and medicines are delivered in a mixed box, the medicine storage area should be physically separated in the box to ensure that medicines and non-drugs are stored separately; If temporary storage is required, the document states that the storage site shall have storage space suitable for the scale of distribution and meet the conditions prescribed for drug storage

National Medical Insurance Administration: Cross-provincial joint procurement of new coronavirus antigen detection reagents will be implemented before April 30

On March 25, the National Medical Insurance Bureau issued a document that the medical insurance departments of all provinces should allow the new coronavirus antigen testing services carried out by public medical institutions to be charged according to the method of "price items + testing reagents" before April 8
.

The government-guided price (maximum price) will be set by the provincial medical insurance departments at a price not higher than 5 yuan per person; the new crown antigen detection reagents (including sampling equipment) are sold at zero mark-up on the actual purchase price

All provincial medical insurance departments will refer to the existing online purchase prices across the country, and before April 30, will further reduce the procurement cost of public medical institutions by organizing and implementing bidding and online purchases and participating in inter-provincial alliance procurement
.

Public medical institutions should purchase the required novel coronavirus antigen detection reagents on the centralized procurement platform of the province, region, and city, and must not purchase offline

Market tide

Unnamed medicine faces the risk of termination of listing

On March 21, the Shenzhen Stock Exchange issued a letter of concern about Shandong Weiming Biology.

Because the financial audit in 2021 was not completed on time, the company was at risk of terminating the listing

Reviews

In recent years, many pharmaceutical companies have been required by regulatory authorities to disclose delisting risk warnings due to untimely letter disclosure, financial fraud and other violations
.

Unnamed Medicine has gradually declined since its listing.
In the past 10 annual information disclosure assessments, 6 times were B, 2 times were C, and the lowest rating was D in the past two consecutive years.
exposure

Cash flow soared 869.

52% year-on-year, GPHL started digital transformation

Guangzhou Baiyunshan Pharmaceutical Group Co.

, Ltd.
, a listed company under GPHL, a Fortune 500 company, announced its 2021 performance report

Reviews

GPHL has become the first company in the world to enter the world's top 500 companies with traditional Chinese medicine as its main business, and is hailed by the industry as another milestone achievement in the development of traditional Chinese medicine in China
.

In the ESG rating published by MSCI, it has been improved for four consecutive years and was rated
A.
"Marketing + scientific research" together to further enhance the strength of independent research and development, product competitiveness and resource integration
.

The highest drop is 98%! The results of the third batch of centralized procurement in eight provinces and two districts are announced

On March 22, the Inner Mongolia Autonomous Region Pharmaceutical Procurement Center issued the "Notice on Publicizing the Results of the Proposed Selection of the Third Batch of Centralized Procurement of Drugs in the "Eight Provinces and Two Districts" Inter-Provincial Alliance"
.
The results showed that a total of 17 varieties and 26 product specifications were included, among which the dihyprophylline flow standard
.
There are 25 companies to be selected, including Shandong Yijian, Harbin Sanlian, Chia Tai Pharmaceutical, North China Pharmaceutical Hebei Huamin, Shandong Luoxin,
etc.
(Inner Mongolia Autonomous Region Pharmaceutical Procurement Center)

Reviews

Eight provinces and two districts have completed three batches of procurement so far, and the speed is astonishing
.
At present, there are several inter-provincial alliances for centralized procurement, including 14 provincial alliances such as Inner Mongolia and 10 provincial alliances such as Shaanxi, etc.
The fields of chemical medicine, decoction pieces and consumables have been involved
.
Under the trend of accelerating the expansion of centralized procurement, it is expected that the cross-regional drug alliance will become a useful supplement to the national centralized procurement in the future and will advance rapidly
.

R & D trends

H medicine was born, forming a "2+7" competition pattern

On March 25, Henlius announced that its first self-developed innovative biological drug PD-1 inhibitor H drug-Hansi (generic name: slulimumab injection) was officially approved by the State Food and Drug Administration.
Approved for the indications of adult advanced solid tumors with unresectable or metastatic microsatellite instability that have failed previous standard treatments, providing patients with new treatment options and empowering domestic tumor precision immunotherapy
.
(Fosun Group)

Reviews

The clinical research data of Hanszoid® for MSI-H solid ^tumors is excellent, and it is believed that it can actively improve the clinical efficacy and provide new ideas and new options for precision tumor treatment in China
.
It can also play a positive role in improving the awareness of "pan-cancer" treatment and promoting the development of precise tumor immunotherapy
.
The number of domestic PD-1 products on the market has now risen to 7, forming a "2+7" competition pattern with two imported PD-1 products
.

Innovent PD-1 rejected by FDA

    On March 24, Innovent announced on the Hong Kong Stock Exchange that it received a new drug listing application from the FDA for sintilimab combined with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer.
Complete reply letter
.
In its reply, the FDA said it had completed its review of the BLA but failed to approve the application, in line with the results of the Oncology Drugs Advisory Committee convened in February
.
(Cinda Bio)

Reviews

This result is not surprising to the industry.
Under normal circumstances, the FDA will follow the ODAC voting results
.
Judging from the previous public review site, the FDA's approval standards for PD-1/PD-L1 will become more and more stringent
.
The industry believes that the FDA's refusal to approve Innovent's PD-1 incident has touched the entire innovative drug going overseas.
The core of pharmaceutical innovation must meet the unmet needs as the goal, and should return to the clinical value-oriented overseas strategy
.

The first in the country! Rehabilitation obtained a class of biological drugs with an implied license for clinical trials

On March 25, Wuhan Kangde Biotechnology Co.
, Ltd.
received the "Clinical Trial Notice" issued by the State Food and Drug Administration, agreeing to the company's clinical phase I and clinical trials of TRA16 for the treatment of secondary hyperoxaluria indications.
Phase II trial
.
The acquisition of this clinical approval is a phased result of the company's preliminary technical research work, and the company will carry out follow-up work in accordance with relevant regulations
.

Reviews

TRA16 is the first class I biological innovative drug independently developed by Kangde, and it is also the only clinical trial drug currently underway in the world for the treatment of secondary hyperoxaluria, which marks that human research on diseases related to oxalate metabolism disorders has improved broad prospects
.

Text editor: Yu Rujin

Format editor: Yu Chenglin