Seven Industry Leaders, Seven Key Insights: Charting the Future of China's Pharmaceutical Development

The 4th China Biopharma Innovation & Investment Conference (CBIIC) in 2019 has just concluded successfully. VCBeat conducted on-site interviews at the event and has compiled their key insights here.

Junshi Biosciences CEO Li Ning: The Proper Use of PD-1 Monoclonal Antibodies—Patient and Physician Education Still Has a Long Way to Go

As tumor immunotherapy has been in clinical application in China for less than a year, many physicians have not yet fully mastered the use and clinical management of PD-1 antibodies, leading to considerable caution. On one hand, although it is recognized that the adverse reactions associated with PD-1 antibodies are significantly milder than those of chemotherapy, clinicians lack comprehensive experience in their diagnosis and treatment. On the other hand, due to factors such as cost and the novelty of the drug, many patients and physicians reserve PD-1 inhibitors as a last line of defense. However, based on the drug’s mechanism of action, better patient immune status correlates with improved therapeutic efficacy. Consequently, current clinical practice does not fully align with the drug’s mechanistic principles, necessitating extensive education and guidance for both healthcare providers and patients to ensure that PD-1 antibodies are used appropriately by those who stand to benefit most. In the long term, this will have a positive impact on market exploration and expansion.

Liu Shigao, Co-founder, President and CEO of Henlius: China’s Biologics Market is Growing Rapidly, a Blue Ocean

In Europe and the United States, the annual market growth rate for innovative biologics is quite limited, with some figures even in the single digits. In contrast, China continues to exhibit a trend of rapid growth. Although China accounts for a high proportion of new cancer cases globally, medication utilization rates remain generally low. The primary reason for this is the high cost of biologic drugs. Thanks to national healthcare insurance policies that benefit the public and the vigorous development of the biopharmaceutical industry, prices of domestic biologics have decreased significantly. The rapid development and regulatory approval of high-quality biosimilars, represented by Hanlikang (rituximab), will further foster healthy market competition and provide more treatment options for physicians and patients. The Chinese biologic drug market remains a blue ocean, with both innovative biologics and biosimilars poised for rapid growth.

Dr. Zhang Dan, Executive Chairman of FangEn Pharmaceuticals: Opportunities and Challenges on China’s ICH Journey

When China first joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the entire industry erupted in celebration. The introduction of management systems and standard guidelines under the ICH framework, along with mutual recognition of data among member countries, has brought a series of impacts to the new drug registration and application environment. First, clinical review processes have been accelerated, while the success rate of New Drug Applications (NDAs) has declined. Second, the accelerated entry of foreign new drugs into the Chinese market has significantly increased short-term pressure on domestic pharmaceutical companies. Third, although China’s accession to the ICH has posed many challenges to local enterprises in the short term, it holds positive long-term significance. To cope with competitive pressure from foreign pharmaceutical companies and accelerate the global expansion of domestically developed new drugs, Chinese pharmaceutical companies will begin to align themselves with ICH standards, enhancing their corresponding production capabilities and management practices.

FibroGen Executive President, Chung Lai-Wah: Healthcare Reform Support Is Highly Beneficial to Innovative Drug Companies

We are highly appreciative of the current direction of healthcare reform. The reform is now placing greater emphasis on and providing stronger support for innovative enterprises, reflecting our country’s trend of prioritizing genuine innovation and hard-core technologies in the biopharmaceutical sector, while also conveying the core objective of benefiting public welfare. This is highly favorable for companies like ours that adhere to rigorous data quality standards and focus on breakthrough innovative drugs. The direction of healthcare reform demonstrates the state’s strong commitment and high-level support for innovation. Adjustments already made to the review and approval processes have benefited the industry. Looking ahead, I anticipate the gradual introduction of additional policy supports, particularly in areas such as market access for pharmaceuticals.

Zhu Jinqiao, Founder of Yifeng Capital: Investors Must Truly Serve Enterprises and Provide Tangible Support

Post-investment management of selected projects should be conducted within one’s capacity. These entrepreneurs are scientists and possess the deepest understanding of their companies; therefore, as shareholders or board members, we must first respect the founders’ visions. Similar issues exist in the United States, where the loss of even a single board seat can jeopardize financing negotiations. To serve effectively as a director, one must thoroughly understand the company; only with such understanding can meaningful contributions be made. A classic case from my own experience illustrates this point. When I served on the board of Directors of Vcanbio, there was an excessive number of investor representatives, which posed significant risks to the company’s future development and organizational structure. Consequently, I took the initiative to step down from Vcanbio’s board. This decision has since become a well-regarded story in the investment community.

Tian Yuan, Founder of Yuanming Capital: The Short-Selling of BeiGene Serves as a Warning to Biopharmaceutical Companies

In mature capital markets such as those in the United States and Hong Kong, short-selling mechanisms serve as a market correction tool. Short sellers create profit opportunities by questioning the authenticity of corporate data, thereby driving down stock prices. However, well-managed companies with strong fundamentals have nothing to fear from short-selling. Following the recent short attack on BeiGene, the company’s management responded swiftly and clarified the inaccuracies in the short seller’s report. A decline in valuation during a short attack is normal; whether the stock price recovers depends on the company’s intrinsic quality. As more biopharmaceutical companies go public, it will become commonplace for short sellers to target prominent biotech firms. This trend serves as a warning to biopharmaceutical companies: all our operations must be robust enough to withstand scrutiny and attacks from short sellers in the open market.

Susan G. Komen President and CEO Basu Juan: China Needs More Systematic Industry Translation Systems

Every major university and research institute in the United States has a well-established technology transfer system, known as the Technology Transfer Office (TTO). This practice dates back to the 1980s and has since become highly systematic. TTOs assist these institutions in systematically managing patent transfers and facilitating commercialization. In contrast, such mechanisms remain scarce in China. While some leading universities, such as Peking University and Tsinghua University, engage in related activities, these efforts are not yet fully systematic and are typically limited to a select few schools or departments. Therefore, if China aims to achieve greater advancements in basic research and translational clinical medicine, it needs to establish a more systematic framework for industrial commercialization.