AstraZeneca today announced that its partner FibroGen (China) Medical Technology Development Co., Ltd. (FibroGen China) has received marketing authorisation for roxadustat in China for the treatment of anaemia caused by chronic kidney disease (CKD) in non-dialysis-dependent (NDD) patients.

The approval, granted by the National Medical Products Administration, is primarily supported by a Phase III trial in NDD-CKD patients with anaemia, in which roxadustat demonstrated a statistically-significant improvement in haemoglobin levels from baseline averaged over weeks seven to nine of treatment, with a mean change of 1.9 g/dL compared to -0.4 g/dL with placebo. This data was published in The New England Journal of Medicine in July 2019.

This marketing authorisation follows the approval of roxadustat in China in December 2018 for anaemia in CKD patients who are on dialysis. AstraZeneca and FibroGen China expect to launch roxadustat in China during the second half of 2019.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “With this approval for roxadustat in China, we are now able to provide this first-in-class medicine to all patients living with chronic kidney disease who experience anaemia, regardless of whether they require dialysis. This is a significant milestone and we look forward to bringing the medicine to patients later this year.”

Anaemia caused by CKD is associated with cardiovascular disease, hospitalisation, cognitive impairment and reduced quality of life, and has been shown consistently to increase the risk of death in patients with CKD. Anaemia becomes increasingly common in patients with CKD as their disease progresses.

For more information: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/roxadustat-approved-in-china-for-the-treatment-of-anaemia-in-non-dialysis-dependent-patients-with-chronic-kidney-disease-22082019.html

www.nmpa.gov.cn

The aim of FIPAA is to become the unified voice of the feed additive and premix industry in this part of the world and to promote, defend and represent the general and common interest. FIPAA wants to achieve this by being a recognized and trusted stakeholder, facilitating the dialogue with the regulatory authorities.

This association is the first of this kind in Asia. It will drive cooperation between companies on non-competitive topics, and more precisely on common issues related to regulation and policies applicable to feed ingredients and premix products related to import and usage in Asian countries.

The expected outcome is to contribute to a more predictable and facilitated framework for innovations to meet the dynamic demand of the feed industry with a lower time-to-market.

For further information: contact@fipaa.org

For further news, please refer to: https://marketing.feedinfo.com/interview-new-asean-feed-ingredient-association-launched-at-feed-additives-asia-2019/

China is blowing through regulatory milestones as it completes an astonishing transformation from a market where basic Western drugs were once scarce to one where life-saving treatments are available ahead of the U.S. — all in less than a year.

Tuesday’s announcement that China has approved an anemia treatment from AstraZeneca Plc and FibroGen Inc. ahead of the U.S. and other markets is the latest high-water mark from a regulator that started the year with a backlog of foreign drugs that were available elsewhere globally.

In April, it approved in nine days Merck & Co.’s HPV vaccine, Gardasil 9, which has been in use worldwide since 2014. A few months later, it gave the green light to Hutchison China MediTech Ltd.’s colorectal cancer capsules, fruquintinib, marking the first time a homegrown medication was approved in China ahead of the U.S. and Europe.

Read more: To Get the Latest Drugs, Head to China

With AstraZeneca and FibroGen’s roxadustat, an anemia treatment for patients with chronic kidney disease who are dependent on dialysis, China has now green-lighted a potential blockbuster — a drug with the potential to hit $1 billion in sales — before the rest of the world.

“This is a milestone, and a sign that the China government is following through with its focus on innovation,” said John J. Lin, Shanghai-based life sciences and health-care partner at EY. “Pharmaceutical companies will pay increasing attention to the Chinese market with respect to research and development.”

The regulator’s rapid reinvention has come in the face of pressure from its growing middle class to gain access to the best drugs and health care available. Where once patients had to travel outside of China to get life-saving medication, Beijing is now determined that its citizens, who have some of the highest rates of cancer, diabetes and liver disease in the world, can get direct access to top drugs first.

China is on track to approve some 50 drugs this year, according to research from consultancy McKinsey & Co., a bigger number than what it approved in total over the last decade.

— With assistance by Rachel Chang

(Source: Bloomberg: https://www.bloomberg.com/news/articles/2018-12-19/china-drug-regulator-transforms-to-world-s-fastest-within-months )

Key Takeaways:

• On April 22, Customs announced the cancellation of label filling for imported pre-packaged foods, meaning from 1st Oct 2019, importers and customs brokers will no longer have to submit to China customs product labelling documentation (inclu. Chinese labels) for imported prepackaged food products during importation.
• Speedier market access: improvement of efficiency during customs clearance which enables less administrative paper work and speeds up market access. 
• The importer shall be responsible for reviewing whether the Chinese label of the imported prepackaged food meets the requirements of relevant GB standards.
• Subject to random on-site inspection by customs or for laboratory testing which will require to provide compliant labelling documents including Chinese labels and other supporting materials.
• If the Customs receives complaint regarding violation of Food Safety, Labelling and other relevant GB regulations, Customs shall verify and once confirmed, act according to law such as requesting for recalls, penalties etc.
• Port to Port differences: After communicating with GACC, for some ports, Customs may still require importers to provide labelling documents as part of the check list for Customs Clearance, although they may not examine the labelling documents.

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What next? Risks and Suggestions

Customs have been piloting this scheme for the past few years in some ports including Shanghai and others for lower risk food categories. What’s changed? This change officially applies to all ports and pre-packaged food categories in China.

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• Risk of random customs inspection it is strongly advised to prepare compliance documentation beforehand such as original label and translation, Chinese labels and other relevant supplementing information.
• Responsibility weighed on the exporter and importer to ensure compliance from the very beginning. Discovering product or labelling in-compliance at a later stage when product is already on China market will have a significant impact with the risks of potential recall and penalties. 
• Laissez-faire & Reliance on Consumer Complaints. A shift from government control to let the workings of the free market do the work. Since the announcement of The Food Safety Law, the policy has increased the penalty for non-compliant food items including violations of Chinese labelling rules, this led to the rise of industry of professional complainers that can earn compensation of 10 times the purchase price. This has encouraged the market to identify non-compliant products to report to Chinese authorities.

Reference (Chinese Only): http://www.customs.gov.cn/customs/302249/302266/302269/2393416/index.html

Contact: Raymond@Accestra.com

Website: www.accestra.com