4 new drugs were approved for new indications in China, from Novartis, Merck, Roche, Chia Tai Tianqing

Recently, the official website of China's National Medical Products Administration (NMPA) announced that a number of new drugs have been approved for new indications in China, including Novartis' innovative biological agent omalizumab, Merck's (MSD) antifungal drug posaconazole, Roche (Roche) anti-IL-6R antibody tocilizumab, Chia Tai Tianqing multi-target tyrosine kinase inhibitor (TKI) anlotinib,

Novartis' innovative biologics omalizumab, MSD's antifungal drug posaconazole, Roche's anti-IL-6R antibody tocilizumab, and Chia Tai Tianqing multi-targeted tyrosine kinase inhibitor (TKI) Anlotinib et al

Novartis: Omalizumab

On April 14, Novartis announced that its innovative biologic omalizumab was approved by the NMPA for a new indication for the treatment of adults and adolescents with chronic spontaneous urticaria

Treatment of adults and adolescents with chronic spontaneous urticaria This is also the only biologic agent approved in China for the treatment of chronic spontaneous urticaria

The efficacy of omalizumab in the treatment of chronic spontaneous urticaria has been demonstrated in several studies

The Phase 3 clinical study in China showed that 75% of patients had significant improvement in pruritus symptoms, and the number of wheals was reduced by 73% compared with the baseline.

Merck: posaconazole

On April 12, Merck & Co.

Posaconazole enteric-coated tablets were approved for the treatment of invasive aspergillosis, and posaconazole injection was approved for the treatment of invasive aspergillosis

According to public information, posaconazole (posaconazole) is derived from itraconazole and exerts its antifungal activity by inhibiting the biosynthesis of ergosterol.

Posaconazole (posaconazole) is derived from itraconazole and exerts its antifungal activity by inhibiting the biosynthesis of ergosterol.

Roche : Tocilizumab

On April 13, Roche announced that its tocilizumab injection (subcutaneous injection) dosage form has been officially approved in China for the treatment of moderately to severely active rheumatoid patients who have insufficient response to disease-modifying antirheumatic drugs (DMARDs).

For the treatment of adults with moderately to severely active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs)

According to the instructions, intravenous tocilizumab requires hospitalization for patients, and each intravenous infusion exceeds one hour, while subcutaneous injection can save more treatment time

Subcutaneous injection of tocilizumab not only shortens the time of a single treatment, but also saves the time for patients to go back and forth to the hospital and go through hospitalization procedures, meet the needs of patients for long-term chronic disease medication management, and make the treatment of rheumatoid arthritis more convenient and efficient and accessible

Chia Tai Tianqing: Anlotinib

On April 14, Chia Tai Tianqing announced that Anlotinib was approved by the NMPA for the fifth indication for the treatment of patients with progressive, locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer

Fifth indication for radioactive iodine-refractory differentiated thyroid cancer, a novel small-molecule multi-targeted tyrosine kinase inhibitor

According to the press release, the approval is based on a Phase 2 pivotal clinical study evaluating the efficacy and safety of anlotinib in locally advanced or metastatic iodine-refractory differentiated thyroid cancer

The median progression-free survival (PFS) was 40.

References:

References:

[1] The fifth indication of Anlotinib -- iodine-refractory differentiated thyroid cancer was officially approved.

[2] Novartis Zhuole® (omalizumab) was approved in China for the indication of chronic spontaneous urticaria.

[3] Roche's anti-epidemic drug tocilizumab for subcutaneous injection was approved in China, ushering in the era of dual dosage forms.
Retrieved Apr 14, 2022.
from https://mp.
weixin.
qq.
com/s/SJB67iqnP9Fb--X0cIrbgg

[4] The new indication of Nocofei® (posaconazole enteric-coated tablets, injection) was approved by the State Drug Administration of China.
Retrieved Apr 12, 2022.
From https://mp.
weixin.
qq.
com/ s/oQQ7GWb9ES3A4vMuWxesgw

[4] The new indication of Nocofei® (posaconazole enteric-coated tablets, injection) was approved by the State Drug Administration of China.
Retrieved Apr 12, 2022.
From https://mp.
weixin.
qq.
com/ s/oQQ7GWb9ES3A4vMuWxesgw