Dear CBI members and Partners,
Kindly find CBI member AstraZeneca's press release relating to their AZD7442 PROVENT Phase III prophylaxis trial.
Download AZD7442 PROVENT P3 HLR_FINAL
Our thanks to AstraZeneca's China team for kindly sharing this information.
CBI member, AstraZeneca, has announced that it has entered into a global development and commercialisation agreement with Japanese drugs manufacturer Daiichi Sankyo, for the promotion of Daiichi Sankyo’s DS-1062, an antibody drug currently undergoing clinical trials to test for efficacy in the treatment of small-cell lung cancer and triple negative breast cancer.
AstraZeneca and Daiichi Sankyo will jointly develop and commercialize DS-1062 worldwide, except in Japan, where Daiichi Sankyo will maintain exclusive rights. This agreement represents the second global antibody drug conjugate collaboration between the two companies, following a similar agreement in March 2019 between AstraZeneca and Daiichi Sankyo for the Japanese manufacturer’s ENHERTU drug, which is aimed at addressing multiple tumours with one treatment plan.
Pascal Soriot, CEO, AstraZeneca said: “[AstraZeneca] see significant potential in this antibody drug conjugate in lung as well as in breast and other cancers that commonly express TROP2 (a protein that forms on the surface of cancer cells) […] We are delighted to enter this new collaboration with Daiichi Sankyo and to build on the successful launch of ENHERTU to further expand our pipeline and leadership in oncology. We now have six potential blockbusters in oncology with more to come in our early and late pipelines.”
AstraZeneca and Daiichi Sankyo will share equally development and commercialisation costs as well as profits from DS-1062 worldwide, except for Japan. Daiichi Sankyo is expected to book sales in U.S. and certain countries in Europe, while AstraZeneca is expected to book sales in other markets worldwide, including China, Australia, Canada and Russia.
CBI member, AstraZeneca has announced that it is launching a new fund with China International Capital Corporation to invest $1 billion in China’s healthcare sector, predominantly to fund research and development.
According to AstraZeneca CEO, Pascal Soriot, the fund will look to invest in Chinese firms, with companies involved in a life-sciences park AstraZeneca helped to open in the city of Wuxi last year, to be among the first to be brought into partnership. AstraZeneca will be a minority partner in the fund, and will mainly play an advisory role in selecting investments and supporting firms.
Mr. Soriot said: “[AstraZeneca] can help by choosing some of those investments [and] we can also help along the way with start-up companies, developing products and helping them find their way around the world. […] it is a substantial investment on our side, but also for our financial partners.”
The company reportedly also plans to expand an existing research and development centre in Shanghai from 450 employees to 1,000 and to establish a new artificial intelligence innovation centre in the city.
AstraZeneca is performing particularly well in China, where sales have doubled since 2012 and foreign drugs manufacturers have witnessed a softening regulatory environment for pharmaceutical firms.
Mr. Soriot said that AstraZeneca wanted to start making drugs it could export globally from China, with areas of opportunity having been identified in oncology and respiratory diseases. “Historically, until today, [AstraZeneca’s] Chinese team has been developing global products for the Chinese market. We now want the Chinese team to take the global leadership on some projects,” he said.
CBI member and Swiss pharmaceuticals manufacturer, Roche, has announced that it has lifted its 2019 sales target for the third time this year, in response to increased demand from China for cancer drugs.
Roche reports that it’s full-year revenue is now seen to be growing at a high-single-digit percentage rate, to what would easily top $60 billion. That is up from the company’s previous mid-to-single digit growth estimate from July.
Over a decade, China has gone from being Roche’s 10th biggest market to its second-largest market, behind the United States. In 2018, Roche did £3.5 billion pounds worth of business in China.
According to Roche, China growth has accelerated to such an extent, that over the first nine months of 2019, Roche recorded 50% growth on last year’s figures.
Roche attributes this growth to increased demand for cancer drugs and improved sales in China’s rural areas where cancers, driven by air pollution and high rates of smoking as well as water pollution and excessive use of chemical fertilisers and pesticides in farming, have been on the rise.
Bill Anderson, head of Roche drugs division, said: “[Roche] is benefitting from the fact that we have a major geographic expansion of both Herceptin and Mabthera, especially into rural areas. […] We’ve got our new medicines launching in China at an increasing pace, so we look forward to continued strong growth, but greater than 50% is hard to achieve in an on-going fashion.”
Roche is the world’s biggest cancer drug manufacturer, and is profiting as China moves to approve more products from western pharmaceuticals makers, in response to rising demand for treatments across a wider range of ailments.
CBI member, AstraZeneca has made public its intention to transition its China business from sales of off-patent medicines towards new and innovative treatments harnessing the Cambridge-based company’s proprietary technology.
AstraZeneca expects new and innovative treatments to contribute to 60% of its China revenue by 2024, up from just a fraction now, as the country’s push to bring novel therapies faster to the market opens up opportunities for global drug makers.
Leon Wang, AstraZeneca executive vice-president for international markets said that AstraZeneca’s sales from newer drugs will likely overtake what the company currently earns from off-patent medicines in the next five years.
China’s contribution to AstraZeneca’s global revenues has jumped from 5.4% in 2012 to 18% in 2018, overtaking Europe as the drug maker’s second-biggest market.
Speaking on the opportunities for AstraZeneca in China, Mr. Wang said: “New drug sales [in China], in terms of proportion, are just getting bigger and bigger. It doesn’t mean that off-patent drugs will decline, but new products are just growing faster. […] the efforts from the [Chinese] government [to encourage foreign pharmaceutical products into the market] are very, very obvious. This will ultimately benefit innovative pharmaceutical companies in the US and Europe.”
Foreign drug manufacturers have found a much more manageable business environment in China in recent years, following the decision of China’s Food & Drug Administration to abolish a rule that had required companies to repeat all drug trials in China before receiving regulatory approval in 2017. Now, big pharmaceutical companies in China can use foreign data to receive approval and launch drugs in sync with their US and European operations.
CBI member, GlaxoSmithKline has announced that it has partnered with Xiamen University and China’s YangShengTang Pharmaceuticals Group to develop a next generation vaccination against human papillomavirus.
The vaccination will combine medical research that until the signing of the agreement was being pursued independently by Xiamen University and GSK, combining an innovative antigen detection method that had been developed by the university with GSK’s proprietary adjuvant AS04 treatment, a substance which enhances the body’s response to antigens.
This agreement reportedly marks the first time that a Chinese vaccine manufacturer has entered into a partnership with a foreign partner to leverage Chinese indigenously developed technology to develop and ultimately commercialise an important vaccine globally.
GSK said the partnership with Xiamen University and YangShengTang Pharmaceuticals will accelerate the development of the next generation of its cervical cancer vaccine.
Under the agreement, YangShengTang Pharmaceuticals will develop a vaccine production line in Xiamen that will comply with Chinese, US and European regulations. This production line will provide to GSK various different HPV vaccine antigens, which will then be combined with GSK’s technologies and sold into the European Union and United States as a final product under GSK branding.
Cervical cancer is the third most common cancer in women. It is estimated that there are over 300,000 cases of the disease amongst women annually, with one woman dying every two minutes as a result. Almost all cases of cervical cancer are caused by the human papillomavirus, with over 100 variants of the virus known to scientists at present.
CBI member, AstraZeneca has reported that China’s National Medical Products Administration has approved the used of Roxadustat in China for the treatment of anaemia caused by chronic kidney disease in non-dialysis dependent patients.
China has become the first country to approve Roxadustat for all chronic kidney patients with anaemia.
This authorisation follows the approval of AstraZeneca’s Roxadustat treatment plan in China in December 2018 for anaemia in chronic kidney disease patients who are on dialysis.
Following approval, AstraZeneca expect to launch the drug and make it available to non-dialysis dependent patients during the second half of 2019.
Mene Panglos, AstraZeneca, Executive Vice-President, Bio-Pharmaceuticals said: “With this approval for Roxadustat in China, [AstraZeneca] are now able to provide first in class medicine to all patients living with chronic kidney disease who may experience anaemia, regardless of whether they require dialysis. This is a significant milestone and we look forward to bring the medicine to patients later this year.”
The approval is primarily supported by Phase III trials in non-dialysis dependent patients with anaemia, in which Roxadustat demonstrated a statistically significant improvement in haemoglobin levels.
Anaemia commonly develops in association with chronic kidney disease in both the dialysis and non-dialysis dependent patients. In China, chronic kidney disease affects an estimated 120 million patients. Although chronic kidney disease may occur at any age, it is more common in aging populations, and its prevalence is increasing. Chronic kidney disease can be both a cause and a consequence of cardiovascular disease and is a critical healthcare issue. There is no treatment available that is curative or has the ability to stop kidney deterioration.
CBI member, GlaxoSmithKline has announced that it has obtained ‘conditional approval’ from China’s National Medical Product Administration to launch its shingles vaccine, Shingrix.
In China, about 3 million adults are affected by shingles each year. Responding to significant public need, the Chinese Government included shingles in a list of “clinically urgently needed new drugs”, released by China’s State Drug Administration to foreign pharmaceuticals companies last August. This list was released to encourage foreign drug developers to apply foreign data and evidence to fulfil China’s drug needs and expedite approval. Consequently, GSK’s Shringix vaccine has been approved for use in China on the same conditions as by the US Federal Drug Administration (FDA) –- the vaccine is only allowed in people ages 50 and above.
Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: “Today’s approval of Shingrix in China is recognition of the significant scientific advance this vaccine represents. In the pivotal studies the vaccine has shown over 90% efficacy across all age groups in the prevention of shingles, a disease that affects one in three people across the Asia-Pacific region. It can result in lasting pain and other complications which can severely impact the quality of people’s lives. [GSK] welcome the Chinese government’s progress to enable faster entry of new products into China and we look forward to working with the relevant agencies to bring the benefits of this vaccine to local communities.”
Shingrix is currently licensed for use in the EU, US, Canada, Japan and Australia, and has performed incredibly well across all markets. In the first quarter of 2019, following US FDA approval, sales of the vaccine reached £357 million – 45% ahead of analysts’ expectations and more than 60% more than the previous quarter.
To read the official press release, please follow the link.
CBI member, Novartis is celebrating 8 years in Chengdu, Sichuan Province this week. The Swiss pharmaceutical company is pioneering a carbon-sink forestry project there, with the intention of developing natural infrastructure to off-set local CO2 levels by re-foresting areas of land which have been destroyed by industrial logging.
The project has been designed to absorb 1.2 million tonnes of carbon dioxide over the next 30 years. To accomplish this, 21 million trees have been planted on 4,095 hectares of deforested mountainside.
Novartis is also offering local businesses training on how they can contribute to sustainable development by tackling climate change.
According to Liu Hongbao, director-general of the Sichuan Forestry and Grassland Administration, “The project has already paid dividends since the launch […] and has offered us innovative ways of using targeted, poverty-relief measures to help people lift themselves out of poverty and improve their standard of living. Related technical integration and demonstration projects have also been launched this year in the context of the Novartis carbon-sink project, which are expected to serve as templates for the development of the green and low-carbon future economy.”
The forest provides another good example of the opportunity that exists in China for foreign firms capable of collaborating with the Chinese state - be it the government or enterprise - by offering consultancy services and international connectivity. The Novartis carbon-sink forestry project is the first carbon-sink forestry project carried out in direct collaboration with a multinational company in China, and builds off the success of similar projects launched in 2010 in Argentina and Mali.
Chen Xiaojing, vice-president of Novartis Group China said that the forest demonstrated the company’s commitment to being in the China market, and that the company looked forward to “A further 30-50 years of careful forest management [to ensure] the Novartis carbon-sink project in Sichuan makes its full impact. […] Novartis is willing to join hands with the government and society in contributing to sound environmental stewardship. This is part of the Novartis’ environment sustainability agenda and its long-standing commitment to China.”
The project hopes it extend purview over the coming years and incorporate enabling greater bio-diversity within the forest. The project is located within one of Sichuan province’s newly introduced bio-diversity hotspots, and is home to the Giant Panda and other endangered species.
Please read more here.
AstraZeneca expects the new medication to launch in China during the second half of 2019.
AstraZeneca has already brought 30 new products to market in China and has almost doubled sales in the market since 2012. The China market generates nearly a fifth of the pharmaceuticals company’s revenue.
The company’s latest offering, Roxadustat, is a first of its kind oral anaemia treatment called a hypoxia-inducible factor prolyl inhibitor. AstraZeneca have taken a novel and innovative approach to treat anaemia which involves using this inhibitor to mimic the body’s response to being at high altitude to boost the production of red blood cells.
Roxadustat has been approved by China’s National Medical Products Administration to be administered to patients suffering from anaemia caused by chronic kidney disease who are on dialysis. The new pill is being advertised as a more convenient alternative to receiving injectable blood enhancers, known as EPOs (erythropoietin) and is less invasive course of treatment than being on dialysis.
The prevalence of chronic kidney disease in China is already relatively high at 10.8% and is predicted to increase over the next few decades, especially among rural regions. The rise in the number of patients suffering from chronic kidney disease is linked to associated surges in the number of people suffering from diabetes and hypertension caused by environmental and behavioural changes linked to China’s socio-economic development. The World Health Organisation has identified obesity in China as a major health concern, with obesity levels in some cities being as high as 20%. Environmental and behavioural changes have been identified as the main casual factor for chronic kidney disease, diabetes and obesity, in the countryside prevalence is much lower across the board; 5%.
AstraZeneca’s Roxadustat medication should make it easier to dispense medication nation-wide and ensure that patients living in rural areas are not deprived treatment because of the costs and reliance on dialysis. Currently 90% of patients suffering from chronic kidney disease undertake a course of haemodialysis, but this treatment plan requires a medical facility to have relatively sophisticated and expensive equipment and facilities in place.
The company recently announced plans to increase R&D capacity in China, demonstrating AstraZeneca’s commitment to the market. The company recorded 12% y/y growth this year and plans to bring 7 new medications to market from their bases in Wuxi and Taizhou in Jiangsu province.
Please read more here.
