ANDA Approvals Boost Chinese Pharma's Global Ambitions

Mar 22, 2018

In the past years, more Chinese pharma companies have begun to march into the international market. This has not only positioned them to further expand their global territories, but has also primed China to raise the quality of its industry as a whole. Receiving FDA recognition is vital to Chinese pharmas’ internationalization strategy. In 2017, FDA approved 38 approved abbreviated new drug applications (ANDAs) from Chinese pharma companies, 16 more than were approved in 2016.

Companies receiving official approvals comprise Huahai Pharmaceutical (8), Jiangsu Hengrui Medicine (6), CSPC (5), Zhejiang Hisun (4), Humanwell Healthcare (3), Novast Laboratories (3), Abison (1), and LP Pharma (1).

2017 FDA-issued ANDAs from Chinese companies

As well as the familiar names in the official ANDA attendees, a rank of new faces emerged as temporary ANDA receivers: Reyoung (Sildenafil), AlignScience Pharm (Glucophage XR), Huaren Pharmaceutical (Valsartan/hydrochlorothiazide), Buchang Pharma (Tadalafil), etc.

 

2017 FDA-issued temporary ANDAs from Chinese companies

Huahai Pharmaceutical tops the list

Huahai Pharmaceutical has a clear leg-up among the competitors and holds the crown in the field. Thanks to years of continuous investment and development, its total ANDAs raised from three in 2011­–2015 to six in 2016. Taking the two temporary ANDAs into account, in 2017 Huahai saw 10 products receive approvals last year.

Huahai Pharmaceutical was founded in 1989, with headquarters in Zhejiang, China. At present, it employs over 6,000 people and has more than 30 subsidiary companies around the globe, including the United States, Japan, Russia, Spain, and India. The company has established long-term collaborations with more than 500 biopharmas around the world, providing medical and health products to nearly 200 countries and regions. It is currently the world’s leading cardiovascular and mental health medical drug manufacturer.

According to Southwest securities, the estimated peak sale of Huahai’s 11 products in the United States will reach a total of $131 million, if the average market share gets to 10%. Its Paroxetine capsule, approved in August of 2017, is the company’s rising star; worth mentioning also is that Huahai is also the first company to receive the FDA quality certification. In recent years, the company has edged out the competitors to become the first Chinese pharma to achieve large-scale sales in the United States.

Zhejiang Hengrui Medicine

Hengrui received only six ANDA approvals in 2017. However, it is not hard to notice that the company is almost entirely centered around potential blockbuster products with deep profits, such as injections, immunoncology drugs, and surgical anesthesia. These areas are traditionally difficult to enter because of complex production processes and technical difficulties.

Hengrui’s Cisatracurium Besilate for Injection, approved at the beginning of 2017, is currently the best muscle relaxant. It is widely applied as an adjunct to the general anesthesia or as a sedation during surgery or intensive care. At present, the US market is dominated by AbbVie; the first generic from Sandoz and Fresenius Kabi follows right after. Hengrui is the third to this field.

The global market has become an increasing important engine of development for Hengrui Medicine, with its focus on both internationalization and innovation. The company is slated to further accelerate its expanding in overseas markets; in the next five years, it aims to acquire FDA or EMA approval for all its main products, building the foundation for its journey of internationalization.

The dark horse: CSPC

It is not surprising to see Humanwell Health and Novast Laboratories on the list. In 2016, Humanwell Health bagged Epic Pharma, an American generic drug manufacturer, for $550 million, acquiring access to both its current products and its ongoing pipeline. In 2017, this acquisition contributed three ANDA approvals and significantly boosted Humanwell Health’s standing in the market.

Novast Laboratories has taken a different strategy. From the very beginning, it has zeroed in on the development and manufacturing of generic drugs for the US and European market. In 2017, Novast Laboratories penned a series of collaborations with Shangdong Buchang Pharma, further beefing up its pipeline.

More surprising is the emergence of CSPC. In 2017, it won a total of five ANDA approvals, which included good market performers such as Clopidogrel hydrogen sulfate. It is clear that CSPC is gradually completing its transition from bulk raw material medicines (vitamin C and antibiotics) and general preparations to specialty bulk drugs and new, high-end preparations and even innovative medicines. Thanks to its three-part approach – ANDA+ high-end preparation overseas collaboration + innovative medicines — CSPC is developing its own unique internationalization path.

Overseas pharmaceutical preparations return to China

Nowadays, FDA certification and the number of ANDA approvals can greatly affect the competitiveness of a Chinese company in the global market. And the value of overseas approval is becoming increasingly prominent in China’s own domestic market.

A typical example is CSPS’s metformin hydrochloride tablets. After obtaining the ANDA approval in the US, CSPC submitted a listing application to the Chinese Center for Drug Evaluation (CDE) on March 2, 2017. Just one month later, it was approved for the priority review. If everything goes well, CSPS’s metformin hydrochloride tablet is likely to become the first drug to pass the consistency assessment in its class.

Clearly, China is taking a strong interest in high-quality ANDA-approved generic drugs. A round of supportive policies has resulted, ranging from registration to bidding to health insurance. In terms of registration and declaration, there are currently two main approaches to speed up the approval process and receive the priority review.

  • Generic drugs receiving overseas ANDAs returning to China: Overseas ANDA-approved drugs that share the same production line, have approved for the listing, and passed on-site inspection in Europe and the United States can receive the priority review.   
  • China-listed generic drugs receiving overseas ANDAs: China-listed generic drugs, which are approved by the EU, the United States or Japan, can receive the priority review.

Once their products receive the priority review, Chinese companies do not need to conduct pharmaceutical researches and BE testings in China. In turn, their products could get approved faster through the consistency assessment, potentially leading to saving millions of dollars down the line.

Meanwhile, the rapid adoption of the consistency assessment also gives the company a headstart over the competition and gives them a lift in future market bidding. Under the current policy, when more than three manufacturers pass the consistency assessment of the same type of drugs, the health and family planning department will no longer select from those who have not passed the evaluation. Thus, the products that have passed will get priority from medical insurances and medical institutions.

When will we see the first NDA approval in China?

From 2012 to 2015, the number of ANDA approvals was basically stable. However, 2016 was the turning point. Since then, significant improvements have been observed. This was especially true in 2017, when the number of ANDA approvals reached a historic high.

This means that the Chinese pharma production is increasingly recognized and accepted by the global mainstream market. However, China still lacks new drug application (NDA) breakthroughs. 

The most well-known example is the compound Danshen Dripping Pill from Tasly. Since it was first approved for IND application on December 9, 1997, its US NDA path has been ongoing. Last year, it was thrust into the public spotlight again when its Phase III clinical trial data was published. FDA confirmed the value of compound Danshen Dripping Pills, but required an additional six weeks of statistically significant confirmatory testing. Whether the Danshen Dripping Pill can eventually complete its NDA journey has become a hot topic in the Chinese pharma industry.

Another widely discussed topic is LY03004, a sustained-release microsphere intramuscular formulation from Luye Pharma.  In October 2015, FDA confirmed that it was submitted to NDA without any further clinical trial requirements. Undoubtedly, this was an exciting news for Luye. It will dramatically reduce the R&D cost and accelerate its speed to market. Currently, LY03004 is regarded as the most likely Chinese drug to first complete the NDA from FDA.

Despite these efforts, China’s pharma companies still do not have any products passing the NDA line. But with the industry shifting gear and taking steps into innovative drug discovery, it is on the edge of erupting on the global market.

Jin Zhang M.D., Ph.D is project and account manager at LakePharma, and editor at The Pharmaceutical Consultant.

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