Recently, the website of china's State Food and Drug Administration (NMPA) announced that a number of innovative drugs have been approved for new indications in China, involving Bayer, Novartis, AstraZeneca and so on
.
Specifically, the September 2 NMPA drug approval document to be collected information shows that AstraZeneca Andatang ® (generic name: dapagliflozin, a sodium-glucose synergistic transporter-2 [SGLT2] inhibitor) chronic kidney disease indications were approved in China to reduce the estimated glomerular filtration rate (eGFR) of adult patients with chronic kidney disease at risk of progression, end-stage renal disease, cardiovascular death and the risk
of hospitalization due to heart failure.
On the same day, Bayer's joint administration of Rivaretal (rivaroxaban tablets) and aspirin in China has also been shown to be approved for use in adult patients with peripheral arterial disease (PAD), including those who have recently undergone lower extremity revascularization due to symptomatic PAD, to reduce the risk
of major thrombotic events (myocardial infarction, ischemic stroke, acute limb ischemia, and large amputation due to vascular lesions).
It is understood that globally, rivaroxaban has been approved for marketing in more than 130 countries or regions, providing protection
for a variety of patients with venous and arterial thromboembolism.
In China, rivaroxaban tablets have previously been approved for use in patients with chronic coronary artery disease or peripheral arterial disease to reduce the risk of major cardiovascular events; and indications for the treatment of venous thromboembolism and the prevention of recurrence in children and adolescents under 18 years of
age.
In addition, Novartis' innovative biologics, Omazuliumab prefilled injection/home use formulation, has been approved by NMPA for use in children, adolescents, and adults aged 6 years and older who, after treatment with inhaled glucocorticoids and long-acting inhaled beta2-adrenoceptor agonists, are still unable to effectively control symptoms of moderate to severe persistent allergic asthma
.
Prior to this approval, the domestically marketed Omalizumab for injection was a lyophilized powder preparation that needed to be dissolved by medical staff before use, and patients had to be injected
by medical staff.
The approval of the pre-filled injection/home use preparation will better benefit Chinese patients and bring them a new way of delivery
.
In addition to a large number of new drugs approved for new indications, clinical trials of new drugs by some multinational pharmaceutical companies have also been approved
.
For example, on August 16, the CDE website showed that Merck's new Class 1 drug MK-4830 injection received an implied license for clinical trials to be developed for the treatment of advanced solid tumors
.
According to the data, MK-4830 is a fully humanized immunoglobulin G4 (IgG4) monoclonal antibody developed by Merck and is undergoing Phase 2 clinical trials
overseas.
Preclinical data suggest that MK-4830 binds to monocytes and granulocytes in the peripheral blood of healthy volunteers and cancer patients
.
In humanized mouse tumor models, treatment with MK-4830 significantly inhibited tumor growth
.
Merck is also exploring the effects
of MK-4830 single-agent or other drugs in the treatment of multiple solid tumors.
Among them, the research on melanoma, colorectal cancer, small cell lung cancer, non-small cell lung cancer, renal cell carcinoma, ovarian cancer, etc.
has entered the phase 2 stage
.
Of course, in addition to the above enterprises, a large number of multinational pharmaceutical companies such as Novo Nordisk, Pfizer, and GlaxoSmithKline are also constantly "adding" to the layout of the Chinese market
.
Among them, many pharmaceutical companies have clearly stated that they will accelerate the entry of new drugs into the Chinese market
in the future.
In this context, the industry expects that the Chinese pharmaceutical market will rapidly
grow into an emerging cluster of global innovation.
