5 Key Trends from the 4th China Biopharmaceutical Innovation & Investment Conference

On September 23, 2019, the 4th China Biopharma Investors Conference (CBIIC) concluded successfully in Suzhou. Over the course of the three-day agenda, speakers from both domestic and international backgrounds delivered insightful presentations. VCBeat has summarized five major trends in the pharmaceutical industry showcased at CBIIC, based on the speeches from the main forum and parallel sessions.

1. Policy First, Accelerating the Development of the Innovative Drug Industry

At the main forum of this conference, keynote speakers analyzed and discussed the new policies implemented in China in recent years. Driven by the regulatory reforms introduced by the drug administration authorities in recent years, the innovative drug industry has experienced overall growth, with a 75% increase in the number of submissions. Over the past year, the drug administration authorities approved 48 innovative drugs, including 38 imported products, among which 18 were anticancer drugs. The newly revised Drug Administration Law ensures standardized industry development through five key aspects: first, clearer regulatory approaches to supporting innovation; second, more clearly defined incentives; third, more detailed management systems; fourth, better-defined primary responsibilities; and fifth, stricter legal penalties. In the future, the drug administration authorities will issue further Implementing Regulations for the Drug Administration Law to provide greater clarity in institutional management.

2. Challenges Facing PD-1 Monoclonal Antibodies: Clinical Data and Market Education

Following the successive launches of three domestically produced PD-1 monoclonal antibodies, the PD-1 mAb market continues to expand. During a roundtable discussion at the launch event, leading Chinese companies in the PD-1 mAb sector highlighted the challenges still facing the domestic market. First, there is a need to generate more robust clinical trial data more rapidly to expedite the expansion of indications for PD-1 mAbs. Second, market education remains critical; as PD-1 therapy represents a largely unfamiliar domain for both patients and physicians, educating doctors on the correct and rational use of these agents is paramount.

3. Accelerated International Exchange: Foreign Pharmaceutical Companies Seek Partnerships in China, While Domestic Firms Pursue Cross-Border M&A

The international and cross-border M&A special sessions held at this conference have expanded its scope to a global level. While the trade war between China and the United States has exerted some impact on cross-border investment activities and collaborative relationships, cross-border investment and transactions will remain a crucial component of the future development of China’s pharmaceutical sector. The more than twenty international projects presented in China attracted significant attention from investors. Meanwhile, Chinese pharmaceutical companies are increasingly active overseas. As valuations of domestic innovative drug enterprises continue to rise, Chinese pharmaceutical firms are gradually turning their focus abroad. Consequently, international exchanges within China’s pharmaceutical industry are poised to become increasingly frequent, facilitating the introduction of more high-quality projects into China.

4. In the Era of Innovative Drugs, Data Is King

Both the keynote speakers at the main forum and the sessions in the “Big Data + Smart Healthcare” parallel track highlighted the critical importance of medical data to the future development of the pharmaceutical industry. China has the potential to rapidly surpass global counterparts in the big data sector for healthcare and broader health wellness, owing to its largest-scale and most comprehensive data categories, as well as the most effective mechanisms and capabilities for data aggregation. Currently, the majority of domestic data originates from hospitals and physicians, leaving significant gaps in other data sources, such as patient-reported outcomes and data captured by wearable devices. Nevertheless, big data research enables pharmaceutical companies to develop drugs at lower costs, reduces expenditures for both the government and patients, and ultimately creates new value within this emerging landscape. Therefore, despite unresolved challenges related to data standardization, ownership rights, protection, and pricing, big data remains one of the key focal points for the future of the pharmaceutical sector.

5. The CXO Industry Gains Popularity, Helping Pharmaceutical Companies Establish International Standards

At this conference, the special session on innovative service R&D featured compelling presentations from various companies. Under new policies such as the 60-day implicit approval for clinical trial applications and the Marketing Authorization Holder (MAH) system, industries including CROs, CMOs, and CDMOs have experienced significant growth. Since China joined the ICH, the CRO sector has expanded considerably; however, this has also exposed long-standing issues in China’s clinical trials. Domestic enterprises must adhere to ICH standards to compete effectively in the broader international market. In this process, CXO companies will play a pivotal role in helping domestic firms truly meet international standards for drug research, development, and manufacturing.