After Xinda, who will take over?

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 overseas

At 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:

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"Blue Book on Internationalization of China's Pharmaceutical Industry (2021)"

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From generic drugs to innovative drugs, ten years of sharpening swords, talk about Hengrui Medicine's ten-year road to innovative drugs
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Yaorongyun

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From generic drugs to innovative drugs, ten years of sharpening swords, talk about Hengrui Medicine's ten-year road to innovative drugs
.
Yaorongyun