The state responded to the abortion of pregnant women; the price of domestic PD-1 medical insurance was exposed; and the tide of senior executives leaving pharmaceutical companies was announced

In the new year, the pharmaceutical industry will not change the eternal bustle.

In the new year, the State Food and Drug Administration issued 17 guiding principles to strengthen the research and development supervision of multiple types of drugs; the results of the medical insurance negotiations were officially implemented, and more patients enjoyed the policy dividends of the national medical insurance control fee; the National Health commission also promoted the landing of insulin collection in an orderly manner, while coordinating the epidemic work at this node of the Spring Festival.

Xi'an has been locked down for more than half a month, and it has been announced that "the social surface has been cleared", and Zhong Nanshan has also confirmed the emergence of the inflection point of the epidemic in Xi'an. However, the epidemic situation in Henan, Shenzhen, Tianjin and other places is still emerging, and the expectations and worries of people everywhere for "going home for the New Year" are the same, and the National Health Commission also responded to the epidemic prevention and control matters during the Spring Festival on the 8th.

Domestic and foreign pharmaceutical companies are still running and flowing at high speed, and within a few days, they have declared their hopes in this field with new drugs that have been listed one after another, and the departure of senior executives, layoffs, and corporate cooperation show the complexity and rhythm of this field.

The Health Bureau has compiled more hot information as follows:

A list of blockbuster policies

1. The national medical insurance payment standard is expected to be unified

Recently, a notice entitled "Notice of the Office of the National Medical Insurance Bureau on Carrying out the Pilot Work of Medical Insurance Drug Payment Standards" was circulated in the industry, requiring all provinces to do a good job in the implementation of the pilot drug payment standards in their administrative regions, and in principle, they will be officially implemented from January 1, 2022.

The proportion of health insurance payments for the same drug varies slightly from province to province. The "Notice" makes it clear that in principle, the medical insurance payment standard for drugs is determined according to the generic name, and the unified payment standard is implemented by the province.

The National Medical Insurance Bureau is very cautious about the pilot of medical insurance payment standards, and there are currently no more than 30 varieties in the pilot area, and there are almost no long-term use varieties of common diseases. The Health Bureau noted that Gansu, Heilongjiang, Xinjiang, Guangdong and other provinces have successively issued documents to determine the pilot varieties of medical insurance payment standards in the province. The industry generally believes that the national version of the medical insurance payment standard is finally coming.

2. Another Chinese medicine collection alliance was launched

On January 4, the 12 provinces (autonomous regions and municipalities) Chinese herbal medicine procurement alliance initiated by Shandong Province and followed up by 11 provinces and cities such as Tianjin, Inner Mongolia, Liaoning and Jilin completed the reporting of Traditional Chinese Medicine Tablets, Formula Granules and Proprietary Chinese Medicines.

According to the notice of Shandong Province, the twelve provinces and cities Of Chinese Medicinal Materials Procurement Alliance and the Sanming Procurement Alliance were formally merged to establish the National Interprovincial Traditional Chinese Medicine (Material) Procurement Alliance. After Hubei and Guangdong, the Shandong Alliance became the third alliance to purchase quantities of traditional Chinese medicines, and the declared varieties included proprietary Chinese medicines, Chinese medicine tablets and formula granules. The era of profiteering in Chinese medicine is coming to an end.

3. The State Food and Drug Administration has issued 17 guiding principles in a row

Since January, the NmPA has issued 17 guiding principles in succession within four working days, involving innovative drugs, generic drugs, rare diseases, innovative drugs, traditional Chinese medicines, clinical trials, etc., which have aroused strong concern in the industry.

These 17 guiding principles are for rare disease drugs, new drugs for traditional Chinese medicines, improved new drugs, as well as innovative drugs for human bioavailability and bioequivalence, drugs for preventing nausea and vomiting caused by anti-tumor drugs, anti-hepatitis C virus drugs, ulcerative colitis treatment drugs, Crohn's disease treatment drugs, etc., and even as detailed as food effects in the process of new drug development, pharmacokinetic research techniques for patients with renal insufficiency, etc. It shows that there will be more and more new drug research specifications in the future.

4. The implementation time of insulin special collection is determined

On January 6, Shanghai Sunshine Pharmaceutical Procurement Network issued the "Notice on Announcing the First Year of National Centralized Drug Procurement (Insulin Special) Agreement Procurement Volume", stipulating that the results of the selection of the special insulin collection will be implemented in May 2022, and the specific implementation date will be subject to the notice issued by various localities.

According to the work arrangement, the medical institutions have completed the confirmation of the purchase volume of the selected products of the insulin special project in accordance with the relevant documents, and the national sixth round of the national insulin collection special national first-year agreement procurement volume and the first-year agreement procurement volume of each region have been determined.

Major events in medicine and health

1. The National Health Commission responds to the abortion of pregnant women

On January 8, the joint prevention and control mechanism of the State Council held a press conference, and Guo Yanhong, supervisor of the Medical Administration Bureau of the National Health commission, responded to the abortion incident of pregnant women, asking other provinces to learn from each other and learn lessons: "When the epidemic does not occur, we must do a good job of careful work plan to ensure that the people's normal medical service guarantee work during the epidemic is not affected in any way." ”

Guo Yanhong particularly stressed that the problems of individual institutions and personnel cannot be used as a sketch of the group, nor can it erase the contributions and dedications made by the health system and the vast number of medical workers.

Following the outbreak of public opinion on the abortion incident of pregnant women on January 5, the local women's federation, the hospital involved, the Xi'an Municipal Health Commission, the Xi'an Municipal Government, etc. have responded successively, the relevant responsible persons have been dealt with, and the director of the Municipal Health Commission has bowed to the pregnant woman who has aborted and apologized.

2. The top management of many pharmaceutical companies has changed, and the tide of departures has continued

At the beginning of the new year, a number of famous pharmaceutical companies have undergone high-level changes.

Ding Weibo, the president of Fresenius Kabi China, who left the company a few years ago, was appointed global chief operating officer and general manager of China by Oulis;

Wang Dong, vice president and head of the retail business unit who has just left AstraZeneca China, is the CEO of Luoxin Health and the senior vice president of the direct business of Luoxin Pharmaceutical, responsible for the strategic planning and management of Luoxin Health. At the same time, he is fully responsible for the management of the direct business of Luoxin Pharmaceutical.

The tide of departures has also continued to intensify from the end of the year to the present.

On January 3, Wang Jie, vice president of Huahai Pharmaceutical, left his post and no longer held any position in the company;

On January 4, Li Huiliang, deputy general manager and chief technology officer of Bloomage Biotech, resigned due to personal reasons and no longer served as the company's core technical personnel;

On January 6, Zhu Lin, deputy general manager and secretary of the board of directors of Sinopharm Co., Ltd., resigned due to personal reasons, and he worked for Sinopharm Co., Ltd. for 16 years, successively serving as the director of the office, the director of the securities department, the secretary of the board of directors, the deputy general manager, and the chairman, director and supervisor of the subsidiary.

On the same day, Liu Luxiang, vice president of Buchang Pharmaceutical, resigned for personal reasons and did not hold any position in the company.

3. Domestic PD-1 medical insurance price exposure

At the beginning of the new year, with the implementation of the new version of the national medical insurance directory, the medical insurance price of domestic PD-1 was exposed.

Xindec's sindili monoclonal antibody was reduced from 2843 yuan / bottle to 1080 yuan / bottle, a decrease of 62%, and the annual fee was about 36,700 yuan.

Junshi's tripletizumab 2ml: 80mg from 906.08 yuan / branch to 825 yuan / stick, 6ml: 240mg specification from 2100.97 yuan / branch to 1912.96 yuan / piece, the annual fee is about 33,200 yuan.

BeiGene is terelizumab from 2180 yuan / branch to 1450 yuan, a decrease of 33%, the annual fee is less than 50,000 yuan.

The price of Hengrui's carelli bead monoclonal antibody is still 2928 yuan / bottle, the price remains unchanged, and the annual fee is about 50,000 yuan.

4. The founder of the company "Blood Cancer Test" was convicted

On January 3, the case of Theranos, a U.S. blood testing company, announced new developments, and founder Elizabeth Holmes faced four of the 11 charges.

Theranos once claimed that by collecting a few drops of blood, it could quickly detect whether people had cancer, diabetes and other diseases, which was considered to have "set off a revolution in disease diagnosis." Elizabeth Holmes was charged with 9 counts of telecommunications fraud and 2 counts of conspiracy to commit telecommunications fraud, of which 4 were convicted and 4 were not convicted. Three other counts have not yet been adjudicated.

A week of new drug inventory

1. Pfizer and BioNTech have joined forces to develop a shingles vaccine

On January 5, Pfizer announced the signing of a global cooperation agreement with BioNTech to develop the first mRNA zoster vaccine in history.

It is reported that this is also the third time that the two companies have joined forces to challenge the existing vaccine landscape after cooperating in the development of influenza vaccines in 2018 and the new crown virus vaccine that has attracted tens of billions of dollars in revenue in 2020. The product candidate will combine BioNTech's proprietary mRNA technology with Pfizer's antigen technology, and clinical trials are expected to take place in the second half of 2022. BioNTech will receive $225 million in funding from Pfizer, of which $150 million is an equity investment.

The shingles vaccine is currently exclusively owned by the GSK family. In 2020, GlaxoSmithKline raised £2 billion with this vaccine.

2. The first domestic CDK4/6 inhibitor was listed

On January 5, the State Food and Drug Administration approved the listing of Dalcilil isethionate tablets, a new class 1 drug of Hengrui Pharmaceutical. At this point, Hengrui Pharmaceutical's innovative drugs listed in China have increased to ten.

Darcily is the first CDK4/6 inhibitor originally developed and marketed in China, and the approved indication is the combination of fulvestrant for the treatment of recurrent or metastatic breast cancer that progresses after endocrine therapy with hormone receptor-positive and human epidermal growth factor receptor 2 negative. At present, there are three CDK4/6 inhibitors on the market in China, including Darcily of Hengrui Pharmaceutical, Pipersili of Pfizer, and Abexili of Eli Lilly, of which Abexili has been included in the national medical insurance directory.

3. Merck's new antiviral drug was approved in China

On January 5, the State Food and Drug Administration approved the listing of Merck's new antiviral drug, Latimovir. The drug was approved for marketing in the United States in November 2017 for the prevention of CMV infection and related diseases.

CYTOME infection is one of the common complications of allogeneic hematopoietic stem cell transplantation, which can lead to diseases including gastrointestinal diseases, pneumonia or retinitis, increasing the risk of transplant failure and death.

4. BeiGene PD-1 was approved for the 6th indication

On January 5, the State Food and Drug Administration approved the beiGene PD-1 inhibitor tirelizumab for the treatment of patients with second- or third-line locally advanced or metastatic non-small cell lung cancer who have disease progression after receiving platinum chemotherapy, which is the sixth indication of the drug, and the first five indications have been included in the medical insurance list.