-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
In the past three years, with the promotion of relevant national policies and the strong support of the capital market, the pace of research and development of innovative drugs in China has accelerated rapidly, and high-quality products are also winning the recognition of overseas markets
Challenge international clinical practice, the only way for innovative drugs to go overseas
Challenge international clinical practice, the only way for innovative drugs to go overseasAt present, both innovative pharmaceutical companies and traditional pharmaceutical companies that are transforming into innovative drugs have turned their attention to foreign countries, vying to meet international standards, and have a strong presence in the international market
At present, some companies cooperate with CRO companies, and some companies build their own overseas clinical development teams and bases (such as BeiGene and Henry Pharma) to better control the quality, speed and cost of trials
Several Chinese innovative drugs have applied for listing in the United States, and international clinical data has more advantages
In 2020 and 2021, no innovative drugs from Chinese companies have yet been approved by the FDA
From the previous results, in the face of FDA approval, innovative drugs that have done international multi-center clinical data that can represent multi-ethnic populations will be more convincing
Table 1 Clinical progress of some Chinese innovative drugs in the United States
Overseas markets can bring huge benefits to enterprises and inject new impetus into the long-term development of enterprises
Overseas markets can bring huge benefits to enterprises and inject new impetus into the long-term development of enterprises .
Four innovative drugs in clinical phase III in the United States
At present, there are several innovative drugs in clinical phase III in the United States of China's innovative drugs (Table 1): Hengrui's camrelizumab and fluzoparib capsules, Betta's ensatinib, and Henry Pharma's KBP-5074
Camrelizumab and Fluzoparib Capsules
In April 2021, the FDA granted Orphan Drug Designation to Hengrui's camrelizumab for injection for the indication of hepatocellular carcinoma
KBP-5074
KBP-5074 is a new generation of non-steroidal selective mineralocorticoid receptor antagonist (MRA), which can selectively and competitively bind to human MR to produce antihypertensive, renal protection and cardioprotection effects
Table 2 Henry Pharmaceuticals R&D pipeline
Ensatinib
Ensatinib (Bemena) is a novel potent and highly selective next-generation ALK inhibitor.
Currently, there are 290 people enrolled in the Phase III clinical trial of the drug in the United States, which aims to evaluate the efficacy and safety of ensatinib and crizotinib in patients with ALK-positive non-small cell lung cancer, and is expected to be completed by the end of 2022
Table 3 Betta Pharma's overseas R&D pipeline
To sum up, Chinese pharmaceutical companies with different development paths have set sail in the wave of internationalization
References:
References:1.
1.
2.
3.
"Blue Book on Internationalization of China's Pharmaceutical Industry (2021)"
4.
From generic drugs to innovative drugs, ten years of sharpening swords, talk about Hengrui Medicine's ten-year road to innovative drugs
.
Yaorongyun
From generic drugs to innovative drugs, ten years of sharpening swords, talk about Hengrui Medicine's ten-year road to innovative drugs
.
Yaorongyun