Clinical Development Strategies for Western Biotech Companies in China
China’s evolving regulatory reforms have greatly impacted review and approval timelines, streamlined processes, and expedited the development of innovative drugs.
The Benefits of Asia-Pacific Clinical Trials For Biotechs
There has been a continued shift of innovation from big pharma companies to biotechs, with the latter paving the ways for advancements in the life sciences industry.
Asia: Preferred Destination for Clinical Trials
Asia is the fastest-growing medicines market globally, with China currently the world’s second-largest market after the US, with medicines spending of $137 billion in 2018, up $40 billion from a decade earlier.
Australia: Preferred Destination for Early Phase Clinical Trials
The clinical trials process is complex. It requires substantial investment and skilled human re-sources, and involves risks, not least, the navigation of complex regulatory processes. To over-come these challenges, small biotechnology companies outsource their early phase clinical studies to contract research organizations (CROs). This white paper highlights research on why Australia continues to be a hub for early phase clinical trials.
Our Latest Reports
Clinical trial landscape of Liver cancer in asia pacific
According to the Globocan 2020 report, liver cancer is the fourth most frequent cancer in Asia, with the region accounting for over 70% of all new liver cancer cases worldwide. Hepatocellular carcinoma (HCC) and bile duct malignancies are highly prevalent in Asia, especially in China and South Korea where the prevalence rate is about five times higher than in Western countries.
Clinical trial landscape of diabetes (type 2) in asia-pacific
Diabetes, which is endemic in most Western countries, is now seeing a surge in developing nations across Asia due to aging, urbanization, and changing dietary habits. It is estimated that about 80% of the people with diabetes now reside in developing countries, and mortality rates due to diabetes are higher in the Asia-Pacific compared to the rest of the world.
Clinical trial landscape of endometrial cancer in asia-pacific
In 2020, Globocan reported over 400,000 new corpus uteri cases, with Asia accounting for about 40% of these new cases. China, where EC is the third most common female malignancy, accounted for nearly half of the new cases in Asia.
Regulatory requirements for clinical trials in Australia
With a streamlined regulatory environment, including no requirement for an IND, and the supportive R&D Government refund of up to 43.5% on clinical research spend, Australia has become a preferred destination for early phase clinical trials.
Accelerating Genetic Therapy Clinical Trials in Asia-Pacific
A growing number of biotechnology companies, both in the West and in Asia, are specializing in gene therapies and other regenerative treatments boosted by the approval of the first genetic therapy agent (tisagenlecleusel) by the FDA in 2017.
Accelerating Immunotherapy Clinical Trials in Asia-Pacific
Over 600 sites across Asia-Pacific have been involved in the clinical development of now approved IO drugs, and hundreds more are experienced in managing clinical trials with immunotherapies for both monotherapy and combination therapies.
Orphan drug trials accelerating in Asia Pacific
We have observed an unprecedented effort in the clinical development of Orphan drugs in the recent years. In fact, in 2018, the majority of new drugs approved by the FDA and EMA were Orphan medicines.
The objective of this report is to describe the Orphan drug development landscape and explain how the positioning of the Asia region has been evolving in the global picture.