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Pfizer announces SFDA approval for Xalkori, looks for more China partnerships

Published: 26 February 2013

Chinese regulators have followed the example of counterparts in the United States, European Union, and Japan in approving US firm Pfizer's personalised lung cancer medicine Xalkori (crizotinib) in record time – the most notable approval through the State Food and Drug Administration's new fast-track review channel. Separately, Pfizer's country manager for China has stated the firm is open to further collaboration with Chinese firms in future, indicative of a probable growing trend.

IHS Global Insight perspective



Pfizer (US) has announced receipt of approval from China's State Food and Drug Administration (SFDA) for Xalkori (crizotinib) as a treatment for non-small-cell lung cancer that is anaplastic lymphoma kinase-positive, the latest fast-track approval for the personalised medicine, which took only four years from discovery to gaining US FDA approval.


The SFDA's review took a rapid 11 months, the drug reviewed through a fast-track process that Big Pharma firms will hope indicates an ongoing trend, as the Chinese government looks to encourage investment in drug development in the country and bring its drug regulation system in-line with international standards.


The separate announcement that Pfizer remains open to forming partnerships with local firms is also likely to represent a future trend, and reflects the increasingly fierce competition in the Chinese market for both domestic and foreign players in light of the government's drug price cutting policies.

United States-based firm Pfizer has received approval from China's State Food and Drug Administration (SFDA) for Xalkori (crizotinib) as a treatment for non-small-cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive, alongside use of an already approved diagnostic test, according to a press release from the firm issued yesterday (25 February).

Xalkori is described by Pfizer as the world's first personalised lung cancer therapy, and was granted approval in China through the Center for Drug Evaluation (CDE)'s fast-track approval channel in a process lasting 11 months from New Drug Application (NDA) to SFDA clearance. The CDE in January issued a positive review of Xalkori, which stated that data from three Phase I, II, and III global trials (rather than trials held in China) were considered. The Phase II study included 234 Chinese patients, and there were 157 Asian patients and 29 Chinese patients in the Phase III study comparing Xalkori with pemetrexed or docetaxel. There was no efficacy or tolerability differences between Chinese and non-Chinese patients. The CDE requested that Pfizer continued its global Phase III and East Asia Phase III trial in order to assess overall survival data, as reported by PharmAsia News, and the CDE also worked with the US firm to establish a standard diagnostic test for ALK-positive NSCLC prior to the approval.

Separately, Pfizer's China country manager Wu Xiaobing has declared that the firm intends to develop further partnerships with local companies in China, speaking in an interview with The Wall Street Journal reported today (26 February). Wu states that Pfizer is open to alliances in research, manufacturing and marketing of drugs, and cites shrinking margins in the country due to government price-cutting policies, as well as the benefits gained from local knowledge of the drug registration process. "If we were alone, it would take such a long time to make our drugs accessible to patients," Wu said.

Outlook and implications

As elsewhere around the world, the approval of Xalkori in China is particularly notable for its speed: 11 months to approval is unprecedented, and signifies that the SFDA is taking steps to improve its notoriously laborious drug approval process to be more in line with international standards. Xalkori's development took just four years from first discovery to gaining initial US FDA approval in August 2011, and the drug is described by one of the principal innovators, Dr Jean Cui, as representing "a paradigm shift in NSCLC treatment… away from a one-size-fits-all approach to biomarker-based treatment", as quoted in the firm's press release (see United States: 29 August 2011: Pfizer's Personalised Late-Stage Cancer Drug Xalkori Receives FDA Approval). Analysts expect that it could generate USD2.5 billion in sales globally, despite evidence from studies indicating that only 3–5% of NSCLC patients are ALK-positive, translating to 28,000–46,000 potential patients globally. Pfizer recently announced a partnership with OxOnc (US) on trials developing the drug for further indications.

How many sales will be generated in China remains to be seen, with the drug unlikely to gain reimbursement for some time. The SFDA approval enables Pfizer to pick a price, and although no pricing details are known as yet the drug could be made available at a similar level to the US, where Xalkori is priced at USD9,600 per month (around USD115,000 per year). In China, Pfizer has made liver and stomach cancer drug Sutent (sunitinib) available to patients through a patient-assistance scheme, and a similar strategy is likely with Xalkori given that reimbursement is unlikely for some time. Xalkori's high cost saw the drug refused reimbursement in Europe last week (see Germany: 20 February 2013: Germany's IQWiG decides added benefit of Xalkori not proven). Given Xalkori's effectiveness, Chinese patients will be hoping that Pfizer can come up with a strategy to make the drug more readily available.

Pfizer's openness to further local partnerships in part reflects difficulties in getting new drugs to market, with the exception of Xalkori. Foreign companies are currently not permitted to carry out first-in-man clinical trials, among other regulatory hurdles. Pfizer's recent activity in China has included setting up a joint venture with Zhejiang Hisun Pharma focused on developing generic drugs, while it has also taken a minority stake in giant distributor Shanghai Pharmaceutical Holdings. Pfizer sees further, broader alliances as likely in future, with both foreign and domestic firms facing pressure on profit margins resulting from the government's price-cutting strategies. The National Development and Reform Commission has cut drug prices four times since 2011, with Pfizer affected by the most recent cuts of up to 20% earlier this year (see China: 9 January 2013: China cuts prices of 400 drugs by average 15%, Big Pharma innovative and generics affected). Greater involvement of multinational firms in China's market would help to improve drug safety levels for consumers, while the recent government reforms are producing much greater market potential in rural areas, where Chinese firms have the advantage of local knowledge, and which foreign firms have so far faced difficulty in penetrating (see China: 25 January 2013: Government health reforms to release pent-up demand in China's county hospitals).

Related articles

  • United States - Japan - China - Taiwan - South Korea: 11 February 2013: OxOnc to help Pfizer with East Asia trials of Xalkori in ROS-1 positive NSCLC
  • United States - China: 13 September 2012: Pfizer Forms Generics JV with China's Hisun
  • United States - China: 3 June 2011: Pfizer Opens New Generic Frontier in China with Hisun Pharma JV
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