Ten Vaccines Approved by China's NMPA in 2023 Target Seven Major Diseases Including Shingles and Pneumococcal Infection

Dec 29, 2023 16:03 CST Updated 16:03

GSK

Pharmaceutical R&D Manufacturer

Sanofi

Pharmaceutical R&D Developer

Pfizer

Pharmaceutical R&D Developer

ZFSW

Vaccine R&D and Manufacturing Companies

In 2023, the National Medical Products Administration (NMPA) approved a total of10 VaccinesProducts, Disease Prevention Mainly IncludesHerpes zoster, rabies, influenza, pneumococcal infection, rotavirus infection, tetanus, and hand, foot, and mouth disease caused by EV71 infectionSeven major categories. The specific situation is as follows, and any omissions are welcome to be supplemented.

1
Herpes Zoster Vaccine

January 31,Changchun Bcht Biotechnology Co.Developed Varicella Zoster Vaccine Live Attenuated (Trade Name:(Ganwei) has obtained the "Drug Registration Certificate" issued by the National Medical Products Administration, marking the approval in China for the world's first attenuated live vaccine production application for herpes zoster applicable to people aged 40 and above.

Currently, there are three manufacturers of shingles vaccines in the global market, respectively:Merck's live attenuated vaccine, GSK's recombinant subunit vaccine, and Changchun Bcht's live attenuated vaccine, among which the vaccines from GSK and Changchun Bcht Biotechnology Co. have been approved for marketing in China.

Chinese enterprises布局该类疫苗的 includeGreen Bamboo Biotech, Shanghai Institute, Maikang BioAmong them, the one with the fastest progress is Green Bamboo Biotech, which has currently entered Phase III clinical trials. It is expected to submit a BLA in Q3 2024 and gain approval for market launch around 2026. (Related Reading:Latest! Chongqing Zhifei Biological Products Co.,Ltd.'s Herpes Zoster Vaccine Submits Clinical Trial Application in China (附17家企业在研进展)）

2
Human Rabies Vaccine

In 2023, three human rabies vaccines were approved for marketing in China. According to the approval timeline, they are respectively:Hualan Biological Engineering,Inc.Lyophilized Human Rabies Vaccine (Vero Cell),Minhai Biotechnology Co., Ltd.Lyophilized Human Rabies Vaccine (Vero Cell) andJiangsu Kangrun Biotechnology Co.,LtdLyophilized Human Rabies Vaccine (Human Diploid Cells).

According to data from Frost & Sullivan, as of June 30, 2023, there are two human rabies vaccines available on the U.S. market: Sanofi's human diploid cell rabies vaccine Imovax and Novartis' chick embryo cell vaccine RabAvert. In China, the domestic market has a larger number of manufacturers and product varieties, with 21 companies approved to produce human rabies vaccines. Among them, 14 manufacturers produce human rabies vaccine (Vero cell), including representative companies such as Chengda Bio and Yisheng Bio; six manufacturers produce human rabies vaccine (hamster kidney cell), represented by companies like Yatai Bio and Yuanda Bio; and one manufacturer produces human rabies vaccine (human diploid cell), which is Kanghua Bio.

3
Influenza Vaccine

In February this year,SanofiAnnounced that its quadrivalent influenza virus split vaccine -- VaxigripTetra -- has received NMPA marketing approval for the 6-35 month age group indication.In May, the company againAnnounce,This vaccine is used forIndications for adults and children aged 3 years and above have been approved by the NMPA for marketing authorization.

On July 13, the vaccine obtained the batch release certificate from the National Institutes for Food and Drug Control (NIFDC) and was officially launched.The serum protection rate of this vaccine against four subtypes of influenza strains is up to 98.7%. It is a unified formulation and full-dose quadrivalent influenza vaccine suitable for the entire population aged 6 months and above. This vaccine has few contraindications, and data shows good tolerance across all age groups after vaccination.

In China, the penetration rate of influenza vaccines is relatively low (the vaccination rate for the 2021-2022 flu season was only 2.46%). Currently,Enterprises in China that have laid out plans for influenza vaccines includeHualan Vaccine, Jindikang, Baik Biotech, Zhifei Biotech, Kangtai Biotech, Tiantan Biotech, Peisen Biotech, Sinovac Biotech, Chengda Biotech, Tianyuan Biotech, Walvax Biotech, Wuhan Institute, Changchun Institute, Shanghai InstituteNearly 20 companies.

4
Pneumococcal Vaccine

It is understood that the polysaccharide capsule is the main virulence factor causing invasive pneumococcal disease. According to the differences in polysaccharide components, pneumococcus can be divided into about 90 different serotypes.By purifying the polysaccharide capsules of different serotypes of pneumococci, multivalent pneumococcal polysaccharide vaccines containing different antigen components can be produced.

Currently, the pneumococcal vaccines that have been approved in China mainly include13-valent pneumococcal polysaccharide conjugate vaccineAnd23-valent pneumococcal polysaccharide vaccineTwo types, among which the 23-valent pneumococcal polysaccharide vaccine is used to prevent pneumococcal infectious diseases in suitable populations over 2 years old. It is one of the main products for clinically preventing pneumococcal infections.

April 17,PfizerThe expanded age indication for the 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) has received marketing approval from the NMPA, with the vaccination age range extended from 6 weeks to 15 months to 6 weeks to 5 years (before the 6th birthday). The vaccine was first launched in China in 2016.

On September 1, Zhifei Biological Products Co., Ltd. announced that its wholly-owned subsidiaryZhifei Green BambooThe 23-valent pneumococcal polysaccharide vaccine developed has been approved for marketing by the NMPA.

Notably, on March 16, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China, a company affiliated with China Biotech Co., Ltd.Lanzhou Biological Products Research Institute Limited Liability CompanySubmitted the marketing application for the 13-valent pneumococcal polysaccharide conjugate vaccine. However, according to publicly available information, the marketing application has been put on hold, but it is still worth continuing to follow up.

5
Rotavirus Vaccine

April 17, China BioLanzhou Biological Products Research Institute Limited Liability CompanyThe self-developed oral trivalent reassortant rotavirus attenuated live vaccine (Vero cells) has received NMPA marketing approval, becoming the first trivalent rotavirus vaccine approved for marketing in China.On December 28, the vaccine received the batch release certificate from the National Institutes for Food and Drug Control of China and is about to begin vaccination.

It is reported that thisThe Phase III clinical trial of the trivalent rotavirus vaccine enrolled nearly 10,000 participants for vaccination, spanning two epidemic seasons, with good safety observed. No vaccine-related serious adverse events with an incidence rate ≥0.1% were observed within 30 days after any dose, and no temporal association was found between vaccination and intussusception. Vaccination with the trivalent rotavirus vaccine effectively prevents infantile diarrhea caused by G1, G2, G3, G4, and G9 rotavirus strains.

As of now, apart from this vaccine from Lanzhou Biological Products Research Institute Limited Liability Company, the rotavirus (RV) vaccines available in ChinaThe vaccines include the Group A rotavirus vaccine approved in 2001 and RotaTeq approved in 2018, both of which are non-immunization program vaccines.

6
Tetanus Vaccine

February 21,Hualan Biological Engineering,Inc.The adsorbed tetanus vaccine has been approved for marketing by China's NMPA. This vaccine can stimulate the body to produce a humoral immune response and is used for the prevention of tetanus.The target population is those with a higher chance of trauma. Tetanus vaccination for pregnant women can prevent maternal and neonatal tetanus.The vaccination site and route are intramuscular injection in the deltoid muscle of the upper arm.

7
Enterovirus Vaccine / Hand, Foot, and Mouth Disease Vaccine

August 1, China National Pharmaceutical Group SinopharmWuhan Biological Products Research Institute Co., Ltd.Wuhan Institute of Biological Products' EV71 Inactivated Vaccine, Weisheng® (Enterovirus 71), Receives NMPA Approval for Age Indication Change: Upper Age Limit for Vaccination Expanded from 3 to 5 Years Old.Following this approval, the applicable age for Wuhan Biological Products Research Institute Co., Ltd.'s Weikangle® has been changed to EV71-susceptible individuals aged 6 months to 71 months.‍

It is reported that the EV71 vaccine is mainly used to prevent hand, foot, and mouth disease caused by EV71 virus infection and can effectively prevent severe cases. In 2016,Wuhan Biological Products Research Institute Co., Ltd.-produced Wusheng Iweile® EV71 vaccine has been approved for marketing. It is currently the only similar product that uses a bioreactor culture, three-step column chromatography purification process, without adding any antibiotics, and can be administered to the anterolateral thigh.

References:

[1] Biologics Approved by China NMPA from January to November 2023. Research and Development Expansion. 2023-12-20.

[2] Medical Observation | Quality Upgrade Boosts Human Rabies Vaccine Industry to a Higher Level. Frost & Sullivan. 2023-08-21.

[3] Heavyweight! The first domestically developed trivalent rotavirus vaccine approved for marketing in China. Lanzhou Biological Products Research Institute Limited Liability Company. 2023-04-20.

[4] Ruitewei | Trivalent Rotavirus Vaccine Express (Phase VI) effectively prevents G1, G2, G3, G4, and G9 rotavirus infections. Lanzhou Biological Products Research Institute Limited Liability Company. 2023-12-28.

[5] Good News! Oral Trivalent Reassortant Rotavirus Attenuated Live Vaccine Approved for Marketing. Vaccine Prevention Exchange. 2023-12-29.

[6] Hualan Biological Engineering, Inc.'s Adsorbed Tetanus Vaccine Approved by China NMPA for Market Launch to Prevent Tetanus! Beijing Biological Products Research Association. 2023-04-22.

[7] Inactivated Enterovirus 71 Vaccine (Vero Cell) Expanded to 71 Months of Age! Qinghai Preventive Vaccination. 2023-09-20.

[8] Marketing Authorization Application for China-produced 13-valent Pneumococcal Vaccine Not Approved... Expressive Promotion. 2023-11-26.

[9] Chinese-produced Flu Vaccines Are Breaking Through. Shell Society. 2023-10-13.

[10] Sanofi's Quadrivalent Influenza Virus Split Vaccine - VaxigripTetra® Approved for Pediatric Use in China. Frontiers of Respiratory Medicine, MeS Medical Science. 2023-03-04.

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Ten Vaccines Approved by China's NMPA in 2023 Target Seven Major Diseases Including Shingles and Pneumococcal Infection

GSK

Sanofi

Pfizer

ZFSW

1Herpes Zoster Vaccine

2Human Rabies Vaccine

3Influenza Vaccine

4Pneumococcal Vaccine

5Rotavirus Vaccine

6Tetanus Vaccine