Two major milestones achieved in overseas market approval process

Chinese pharmaceutical and healthcare companies are seeing an increasingly stronger presence in the global market with effective strategies, reflected by more new drug registrations abroad, diversified international mergers and acquisitions and product licensing progress.

In 2019, the United States Food and Drug Administration approved or tentatively approved 86 new generic drug applications－known as abbreviated new drug applications or ANDAs－from Chinese pharmaceutical firms, according to a recent report from the China Chamber of Commerce for Import and Export of Medicines and Health Products.

Among the approvals, three were for first generic drugs, which allow holders a 180-day marketing exclusivity period.

A total of 13 ANDA approvals were tentative－the ANDA is ready for approval but the FDA is blocked from approving them because of remaining patents or exclusivities related to the reference listed drug.

The Healthcare Executive Institute, a Beijing-based think tank, also showed an upward trend in the number of generic drug approvals Chinese companies have received from the FDA in recent years.

In 2018, Chinese drugmakers received 79 generic drug approvals. In 2017 and 2016, the numbers were 38 and 22, respectively. Before 2016, Chinese drug firms had fewer than 15 ANDAs approved each year on average.

Apart from companies that already have a large number of ANDA approvals－such as Shanghai Fosun Pharmaceutical Group Co Ltd and Jiangsu province-based Novast Laboratories Ltd－an increasing number of Chinese companies are strengthening their presence as they go global and win ANDA approval.

The list includes drugmakers like Beijing Tide Pharmaceutical Co Ltd, Zhejiang Jutai Pharmaceutical Co Ltd and Jiangsu-based BrightGene Bio-Medical Technology Co Ltd.

Innovative drugs developed by Chinese firms have also made breakthroughs in overseas markets.

In November, biomedicine company BeiGene Ltd's cancer treatment Brukinsa (zanubrutinib) capsules gained FDA Accelerated Approval. The drug treats adult patients with mantle cell lymphoma.

About a month later, Conjupri (levoamlodipine maleate) tablets, developed by Hebei province-based CSPC Pharmaceutical Group Ltd, was approved by the FDA for treatment of hypertension.

That made the high blood pressure medicine the first innovative Chinese drug to obtain full approval following a standard review by the FDA.

Wang Maochun, vice-president of the chamber, said the two new drug approvals indicate that innovative drugs from China are being increasingly accepted by the high-end spectrum of the international pharmaceuticals market.

Shi Lichen, founder of Beijing Dingchen Consultancy, said the approvals also mark the international pharmaceutical community's higher recognition of Chinese drug quality and that more Chinese pharmaceutical companies are eyeing overseas markets as their R&D capabilities rise.

"More high-quality Chinese drugs will be going abroad and improve the Chinese pharmaceutical industry's image overseas given the increasing R&D and innovation capabilities of those companies," Shi said.

Chinese pharmaceutical and healthcare companies' accelerated steps in going global are also mirrored in the rise of overseas M&As, as well as the spike in international cooperation programs regarding product license-in and license-out.

"Through overseas M&As, Chinese companies can expand overseas marketing channels, enrich product lines, conduct overseas clinical trials, increase market share, enhance business layout and legally acquire technologies. Overseas M&As have become increasingly important in the process of Chinese pharmaceutical companies' expansion in international markets," Wang said.

In 2019, Chinese companies conducted overseas M&As in areas including blood products, generic drugs, medical devices, contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), biomedicine as well as nutrition and healthcare, the chamber said.

US companies are top M&A targets for Chinese pharmaceutical and healthcare companies, followed by European firms that lead in certain areas.

M&As in Southeast Asia aim at expansion into local healthcare service markets, while M&As with Australian nutrition and healthcare companies are intended to help meet surging demand for such products in the Chinese market.

The report also said product pipeline license-in and license-out strategies have become a very important tool for Chinese pharmaceutical and healthcare companies to seek more open and innovative R&D models and have a bigger influence in the global industry chain.

The report said Chinese companies had 80 license-ins in 2019, and 13 license-outs, citing statistics from biopharma information company Cortellis Deals Intelligence.

Most of the license-in programs were for tumor treatments, and the rest were in fields such as artificial intelligence drug development, ophthalmology and cell therapy.

The license-out programs mainly involved areas such as tumor treatment, neurological medicines, immunotherapy and blood lipid control.