Pfizer accepts two companies in 3 days; Huada is included in the US list; Roche, Siemens executives change

National Day holiday, the 2022 Nobel Prize winners were announced, and the Physiology or Medicine Prize was won by Swedish paleogenomics scientist Swante Pabo.

The bird flu outbreak in Europe this week has raised concerns. According to reference news, the European Center for Disease Control and Prevention issued a warning on the 3rd that Europe is experiencing the largest outbreak of highly pathogenic avian influenza on record, so far 48 million birds have been affected. The place was culled.

After the Biden administration took office, US economic sanctions against Chinese companies continued. WuXi Biologics has just been removed from the UVL list by the U.S. Department of Commerce, and BGI has been included in the “Military-Involved Enterprise List” by the U.S. Department of Defense. In addition, Roche’s global leadership has changed; Siemens’ original Asia-Pacific division has been split; Pfizer has acquired two biopharmaceutical companies for three consecutive days.

For more information on the pharmaceutical industry, the Health and Knowledge Bureau organizes the following:

Heavyweight Policy

1. A large number of consumables are withdrawn from hanging nets

On October 8th, the Jiangsu Provincial Public Resource Trading Platform issued the “Notice of the Provincial Public Resource Trading Center on Publicizing the Proposed Revocation of Online Medical Consumables”. The net withdrawal products include 47 kinds of patches, reagents, sheath intervention systems, etc. The products are from 21 medical device companies such as Johnson & Johnson, Cordis, and Antu Bio.

Except for one reagent, most of the consumables were withdrawn from the network due to enterprise application. According to the “Notice on Announcement of Medical Consumables to be Revoked from the Internet” issued by Jiangsu Province in August, If an enterprise applies for revocation of the Internet connection, it shall not add new products to apply for the Internet connection within one year, or increase the specifications and models through information changes >.

2. The purchase of medicines from Hohhot Medical Insurance Pharmacy is included in outpatient co-ordination

On October 7th, Hohhot issued the “Notice on Doing a Good Job in Outpatient Basic Medical Insurance for Outpatients and Designated Retail Pharmacies”, proposing that: Hohhot employees insured in outpatient coordinators at designated pharmacies The purchase of medicines and medical expenses within the scope of the medical insurance policy can be included in the overall coverage of general outpatient clinics.

According to the standard, starting from next year, if the general outpatient medical expenses in Hohhot exceed the threshold of 1,000 yuan within one year, employees and retirees will be paid 60% and 70% of medical insurance respectively< /strong>.

Before this, Hebei has gradually rolled out the work of bringing designated retail pharmacies into the scope of outpatient overall protection.

3. Shenqiu, Henan: 50,000 reward for one positive case found by hospital, etc.

According to the news of the “Shenqiu Today” official account in Zhoukou, Henan Province on the 4th, a “sentry” early warning reward and punishment mechanism will be implemented throughout the county. “Sentinels” are mainly primary medical institutions, hotels, pharmacies, supermarkets, taxis, etc.

The news shows that yellow code personnel with medium and high-risk travel history found in the above places will be rewarded 200 yuan per person, and red code personnel will be rewarded 500 yuan per time. Fever patients with a history of living in medium and high-risk areas are found to be rewarded 5,000 yuan per person. Fever patients who are diagnosed as positive by nucleic acid testing will be rewarded 50,000 yuan per person.

After the news was sent out, it caused heated discussions, and “Shenqiu Today” has now deleted this article.

4. Five kinds of chronic diseases can be directly settled by medical insurance across provinces

On October 5th, the General Office of the State Council issued the “Opinions on Expanding the Scope of “Cross-provincial General Administration” of Government Services and Further Improving Service Efficiency, 22 new government services “cross-provincial services” were added. “Provincial General Office” matters, including the registration of urban and rural residents’ endowment insurance, and the direct settlement of chronic and special diseases across provinces.

The list in the “Opinions” shows that for five outpatient chronic diseases, including hypertension, diabetes, outpatient radiotherapy and chemotherapy for malignant tumors, uremic dialysis, and anti-rejection treatment after organ transplantation As long as the insured person holds the qualification for outpatient chronic and special disease certification, can enjoy direct settlement services in designated medical institutions in the inter-provincial network.

Industry Events

1. Roche Diagnostics Leadership Change

On October 3, the Roche Group announced new appointments. Matt South, head of Roche Diagnostics North America, will be CEO of Roche Diagnostics and a member of the Roche Executive Committee from 2023.

Matt South joined Roche in 2002 as Senior Molecular Account Manager before leading Roche Diagnostics and Pharma in Japan, Ireland and more. In 2019, he served as CEO of Roche Diagnostics North America after a short stint as head of global commercial product strategy at Gilead.

Since the outbreak of the new crown epidemic, Roche’s diagnostics business segment has performed well, with revenue increasing by 29% year-on-year in 2021, and maintaining a 10% increase in revenue in the same period in 2022, reaching 9.948 billion Swiss francs, or about RMB About 70 billion yuan.

On July 21 this year, the former CEO of Roche Diagnostics succeeded Schwan as Chairman of the Board of Directors of Roche Group.

2. Pfizer acquired Biohaven and GBT in three days

On October 3 and 5, Pfizer announced the acquisition of Biohaven for $11.6 billion and GBT for $5.4 billion.

Biohaven is a neurological disease drug development company. The main migraine drug Nurtec ODT has net revenue of $124 million in the first quarter of 2022. Pfizer is mainly to win this drug , Biohaven’s ALS and OCD medical businesses will be spun off into the new Biohaven. The acquisition is one of the largest pharmaceutical mergers and acquisitions in the world in 2022.

GBT was established in 2011 to develop drugs for sickle cell disease. In 2019, GBT’s sickle cell disease treatment drug Oxbryta was approved in the United States, and two other drugs are in Phase 3-4 clinical trials. Pfizer’s acquisition will strengthen its business in rare diseases.

3. BGI was included in the US “List of Military-Involved Enterprises”

On October 5, the U.S. Department of Defense DOD issued an announcement that, in accordance with the statutory requirements of Section 1260H of the National Defense Authorization Act for the Fiscal Year 2021, 13 companies including BGI were included in the list of “involved companies”. List of Military Enterprises”.

The “List of Military-Involved Enterprises” once included 47 companies from AVIC and China Electronics on June 3, 2021. With this updated list, a total of 60 companies are listed in column, including Sinochem, 360, Huawei, Shenzhen DJI, Shenzhen Dahua and other companies.

Under U.S. Treasury Department regulations, listed companies face barriers to cross-border acquisitions in the U.S.. On the 15th of last month, after the Biden administration signed an executive order, the cross-border acquisitions of China Biopharmaceuticals and Asymchem were blocked.

4. Only 157 million yuan was raised in the listing of Emmy vaccine

On October 6th, the Amy vaccine was listed on the Hong Kong Stock Exchange. Before that, the Amy vaccine had twice applied for listing on the Science and Technology Innovation Board and the Hong Kong stock market and was rejected. This time it finally succeeded. After breaking in Hong Kong on the first day, it rose on the 7th. The total market value exceeds 30 billion.

Aimei vaccine is known as “China’s second largest vaccine company”, second only to Sinopharm Zhongsheng. At present, Emmy has 8 commercial vaccines targeting 6 disease areas. Recombinant hepatitis B vaccine and human rabies vaccine are the company’s main products.

Although it has a good reputation, the performance of Emmy Vaccine in 2021 is not satisfactory, with a loss of 676 million yuan. Emmy Vaccine explains the increase in R&D expenditure and the decrease in revenue caused by the new crown epidemic. According to the prospectus, Emmy Vaccine’s IPO raised only HK$157 million. In 2021, the R&D expenditure of the Emmy vaccine is 307 million yuan, and the fundraising cannot support its R&D expenditure for one year.

5. Split of Siemens Healthcare Asia Pacific

On October 4th, Siemens Healthineers’ official website announced that the former Asia-Pacific region will be divided into China region and Asia-Pacific region including Japan. The change is effective from October 1. The China region is led by Wang Hao, president of Greater China, and the new Asia Pacific region is led by Vy Tran, former Varian Chief Compliance and Quality Officer.

Official Weibo introduced that in 2021, the former Asia-Pacific region will achieve revenue of 4.82 billion euros, accounting for 27% of Siemens Healthcare’s total global revenue. Within the Asia-Pacific region, the Chinese market revenue reached 23.5 euros, accounting for about half of the total revenue in the Asia-Pacific region.

Siemens Healthcare board member Tao Lin said that the status of China will be enhanced again after this split.

New Drug Inventory

1. The new diabetes drug Dopagliflozin was approved

On October 8, the State Food and Drug Administration issued an announcement that Hua Medicine Class 1 innovative drug Dopagliflozin Tablets was approved for marketing. This medicine is indicated to improve glycemic control in adults with type 2 diabetes.

Dopagliflozin Tablets is an innovative oral drug developed by Hua Medicine and produced by Desano. After 10 years, it was finally approved for listing. It is the first glucokinase activator drug approved for marketing. According to Chen Li, founder of Hua Medicine, the failure of glucokinase is the root cause of type 2 diabetes, and Dopagliflozin is expected to control the progress of type 2 diabetes from the source.

2. Genting Xinyao’s new antibacterial drug approved in Hong Kong

On October 8, Genting Xinyao announced that the Department of Health of the Hong Kong Special Administrative Region of China approved the launch of its new antibacterial drug Elacycline, which is suitable for adults with complicated intra-abdominal infections.

Elacycline is a new broad-spectrum, fluorinated tetracycline-containing intravenous antibacterial drug for the treatment of Gram-negative, Gram-positive, anaerobic, and other infections. Developed by Tetraphase, a subsidiary of La Jolla, in February 2018, Genting Xinyao won the exclusive development and commercialization rights of the drug in Greater China, South Korea and some Southeast Asian markets. At present, the drug has been submitted to the State Food and Drug Administration for listing.

3. Eli Lilly’s new weight loss drug enters FDA fast track

On October 6, Eli Lilly announced that its weight loss drug tirzepatide has entered FDA Fast Track treatment for adults who are obese or overweight.

Tirzepatide is a dual GLP-1R/GIPR agonist that requires weekly subcutaneous injections. The drug was first approved in the United States in May this year for adults with type 2 diabetes.

Novo Nordisk’s semaglutide was approved for obesity in June last year. Once Tirzepatide’s obesity indication is approved, Lilly and Novo Nordisk will share the global obesity market of 10 billion.

4. Abbott’s monkeypox test kit for emergency use in the United States

On October 7, the US FDA granted emergency approval to Abbott’s real-time PCR monkeypox detection kit, Alinity m MPXV.

Since May this year, monkeypox virus outbreaks have occurred in Europe and North America. On August 4, local time, the U.S. Department of Health and Human Services declared a state of emergency in the United States due to the monkeypox outbreak. On September 7, the PCR reagent developed by Quest Diagnostics received emergency approval, which is the first EUA for monkeypox testing. Domestic companies Livzon Group, Zhijiang Bio, Huaren Pharmaceutical, BGI and other companies also have corresponding layouts.

Writing | Yang Xixia

Editing|Jiang Yun Jia Ting

Operation | Twenty-Three

#domestic innovative pharmaceutical companies##2022Nobel Prize#