From February 28 to March 4, according to incomplete statistics, there are 9 drugs on the market in China, 7 injections, 1 capsule, and one tablet, and the indications include immune diseases, lung diseases, anemia, migraines, hepatitis B, etc., of which 3 drugs are for the treatment of immune diseases.
Ambroxol hydrochloride injection: for the treatment of acute and chronic lung diseases
On March 4, China Resources Shuanghe issued an announcement that its wholly-owned subsidiary Shuanghe Limin produced and developed ambroxol hydrochloride injection through the consistency evaluation of generic drug quality and efficacy.
Ambroxol hydrochloride injection is suitable for acute and chronic lung diseases accompanied by abnormal sputum secretion and poor sputum excretion.
Methylcobalamin injection: for the treatment of peripheral neuropathy and anemia of a kind
On March 4, Yabao Pharmaceutical Group Co., Ltd. announced that the company's methylcobalamin injection (1 ml: 0.5 mg) passed the consistency evaluation of generic drug quality and efficacy.
Methylcobalamin injection is mainly used for the treatment of peripheral neuropathy and macrocytic anemia due to vitamin B12 deficiency. Up to now, including the original research company, a total of 24 domestic manufacturers have obtained approval for the production of methylcobalamin injection, and 3 companies have passed the consistency evaluation.
Adalimumab injection: for the treatment of immune diseases
On March 3, Junshi Bio's Adalimumab Injection (Junmaikang) was approved for listing, which is a product jointly developed by Junshi Bio and Maiwei Bio, which became the sixth adalimumab biosimilar in China. At the same time, this is also the first biosimilar drug approved for marketing by Junshi Biology.
Junshi Bio R&D pipeline (clinical stage). The picture is from the official website of Junshi Biology
Adalimumab is a fully human anti-tumor necrosis factor α (TNF-α) monoclonal antibody developed by AbbVie for the treatment of immune diseases, the trade name is Humira, and 6 biosimilars have been approved for marketing since 2019.
Dexmedetomidine hydrochloride injection: for sedation under general anesthesia
On March 3, the official website of the State Food and Drug Administration showed that the dexmedetomidine hydrochloride injection of the 3 types of generic drugs in Chia Tai Qingjiang was approved for production and regarded as overrated.
Dexmedetomidine hydrochloride belongs to the alpha2-adrenoceptor agonist, which has sedative, analgesic, anxiolytic and other effects, and is clinically used for sedation during endotracheal intubation and mechanical ventilation in surgical patients undergoing general anesthesia.
Levofloxacin sodium chloride injection: for the treatment of infections caused by susceptible bacteria
On March 3, according to the website of the State Food and Drug Administration, Yangtze River Pharmaceutical's levofloxacin sodium chloride injection was approved for marketing and was deemed to have passed the consistency evaluation.
Levofloxacin is a quinolone antibiotic that is suitable for respiratory infections, urinary tract infections, reproductive infections, skin and soft tissue infections, intestinal infections, sepsis and other infections caused by sensitive bacteria.
Flunarizine hydrochloride capsules: for the treatment of migraines
On March 3, Shanghai Pharmaceutical issued a corporate announcement that its subsidiary Shandong Xinyi developed fluguiltryzine hydrochloride capsules through the consistency evaluation of generic drugs.
Flunarizine hydrochloride capsules are mainly used for the prophylactic treatment of typical (with aura) or atypical (without aura) migraines.
Tenofovir disoproxil fumarate tablets: for the treatment of chronic hepatitis B
On March 2, Baiyunshan issued a corporate announcement that the tenofovir disoproxil fumarate tablets developed by its subsidiary Baiyunshan Pharmaceutical were approved.
Tenofovir disoproxil fumarate is highly potent and low-resistant to hepatitis B virus and is a first-line drug for the treatment of chronic hepatitis B that is unanimously recommended by multinational guidelines for the prevention and treatment of chronic hepatitis B. Suitable for the treatment of adults with chronic hepatitis B and children over 12 years of age (inclusive) and in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults.
Rituximab injection: for the treatment of rheumatoid arthritis
On March 1, the first monoclonal antibody drug independently developed by Henlius of Zhangjiang Pharmaceutical Company, Rituximab Injection (Hanlikang), was approved for a new indication, combined with methotrexate, for adult patients with moderately severe active rheumatoid arthritis who have poor efficacy of one or more TNF-α inhibitors, providing a new drug choice for patients with autoimmune diseases.
The Henlius staff is doing research. The picture is from the official website of Henlin
Hanlikang is the only rituximab in China that has declared approved rheumatoid arthritis indications, and it is also the rituximab with the most approved indications in China.
Infliximab: used for the treatment of autoimmune diseases such as rheumatoid arthritis and rigidity
On February 28, Genor Biotech announced that its autoimmune therapeutic drug infliximab (Jiayoujian) was approved, becoming the third domestic infliximab biosimilar. It is used for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriasis, ulcerative colitis in adults, Crohn's disease in adults and children over 6 years of age, and fistula Crohn's disease.
Infliximab is a human-mouse chimeric monoclonal antibody (trade name: Classg) developed by Johnson & Johnson/Merck that specifically blocks tumor necrosis factor (TNF-α), which was approved for marketing in China in 2006. The 2 infliximab biosimilars that have been listed in China are from Taizhou Maibotec Pharmaceutical and Haizheng Biologics.
Editor-in-charge: Qiao Jingfang