AstraZeneca's First Major Move in China Post-Leadership Shake-up: Acquires Full Rights to Nobel Prize-Linked Drug Roxadustat-VCBeat

Image source: Visual China

Interface News reporter |Huang Hua
Interface News Editor |Xie Xin

On February 20, AstraZeneca announced an agreement with FibroGen, under which the company will acquire FibroGen China for a consideration of approximately $160 million. According to the agreement, FibroGen will receive an enterprise value of $85 million and approximately $75 million in cash held by FibroGen China at the closing of the transaction, totaling about $160 million. The transaction is expected to be completed by mid-2025.

AstraZeneca and FibroGen have a long-standing partnership, and the current acquisition is AstraZeneca's first major move in China following the "Wang Lei controversy" and a series of high-level management upheavals in its China division.

Regarding the aforementioned transaction, Leo Lin, the newly appointed General Manager of AstraZeneca China, stated that this acquisition expands AstraZeneca's investment in China's pharmaceutical market. He emphasized the company’s commitment to bringing potentially life-saving innovative medicines to Chinese patients and supporting local innovative enterprises in their global development.

On the evening of October 30 last year, AstraZeneca announced that Leon Wang, Executive Vice President, Global, Chairman of International Business, and President of China, was cooperating with an investigation in China. Two months later, AstraZeneca quickly filled the vacancy caused by Leon Wang's investigation.

That is, on the evening of December 4th last year, AstraZeneca announced a personnel appointment, declaring that Iskra Reic would serve as Executive Vice President, Global Head of International Business, fully responsible for regional operations including China, Asia and Eurasia markets, Middle East and Africa, Latin America, Australia and New Zealand.

Subsequently, an internal letter released by Iskra Reic revealed that Lin Xiao will assume the role of General Manager of AstraZeneca China, reporting directly to Iskra Reic. Currently, the official website indicates that Lin Xiao serves as the General Manager of AstraZeneca China and the General Manager of AstraZeneca China’s biopharmaceutical business.

In the product aspect, after the completion of the delivery, AstraZeneca will acquire all rights to Roxadustat Capsules (Chinese trade name: Ai Rui Zhuo) in China, while FibroGen will retain its rights to Roxadustat in the United States and markets not authorized to Astellas Pharma.

Roxadustat is a special and controversial product in the pharmaceutical industry. Its uniqueness lies in the fact that it is the world's first hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), a technology discovery that won the 2019 Nobel Prize in Physiology or Medicine. It is also the first new drug in the field of renal anemia in China in 30 years.

Moreover, on a global scale, China was the first country to approve the launch of Roxadustat. This is also the first global new drug developed by a foreign pharmaceutical company that achieved its first market launch in China. On December 17, 2018, the product was approved for marketing by the National Medical Products Administration (NMPA) through an expedited priority review and approval process, and it was industrially produced in Beijing. It is used to treat anemia caused by chronic kidney disease (CKD), and can be taken by both dialysis and non-dialysis patients.

However, due to safety concerns, the approval process of Roxadustat overseas has been very tortuous. In July 2021, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) voted against the approval of Roxadustat for the treatment of anemia in chronic kidney disease (CKD) patients. The voting result regarding anemia in dialysis CKD patients was 12 to 2, and the result for non-dialysis CKD patients was 13 to 1. Subsequently, Roxadustat's market entry in the U.S. was rejected by the FDA.

More than two years after being rejected by the FDA, the overseas commercial rights for roxadustat have also changed. AstraZeneca has returned the rights for roxadustat in the United States and other regions of the world to FibroGen. The reason it is referred to as "returned" is because in 2013, FibroGen and AstraZeneca reached a cooperation agreement for the joint development and commercialization of roxadustat in China, the United States, other markets in the Americas, Australia/New Zealand, and Southeast Asia.

In addition, the authorized regions for Astellas' roxadustat include Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. To date, roxadustat has also been approved in Europe, Japan, and other countries for the treatment of anemia in chronic kidney disease (CKD) patients who are either on dialysis or not on dialysis.

Unlike the situation overseas, roxadustat not only hit the Chinese market early but also became a commercially successful drug. According to data from Menet, in 2023, the sales revenue of roxadustat capsules in urban public hospitals in China reached 1.397 billion yuan. Moreover, since 2020, roxadustat has consistently ranked first in China’s renal anemia market. This success is also attributed to AstraZeneca's influence in the Chinese market.

Currently, the development of Roxadustat in China is still ongoing. According to FibroGen's official website, the indication for Roxadustat in treating chemotherapy-induced anemia (CIA) has entered Phase 3 clinical trials in China. Regarding the progress in treating chemotherapy-induced anemia, Lin Xiao mentioned in today’s speech that AstraZeneca looks forward to a regulatory decision on the use of Roxadustat for treating chemotherapy-induced anemia by early 2025.

On the other hand, FibroGen's situation is not good. Last July, FibroGen announced that it would cut about 75% of its U.S. workforce and halt the development of CTGF inhibitor Pamrevlumab. This also means that selling its China assets and only commercialized drug to AstraZeneca can be used as an emergency solution.

According to FibroGen's announcement on February 20, CEO Thane Wettig acknowledged that the company believes selling its China business and repaying the term loan is in the best interest of the company and its shareholders. After selling FibroGen China to AstraZeneca, the company will repay the term loan to an investment fund managed by Morgan Stanley Tactical Value and will be able to continue advancing the clinical development project FG-3246 (CD46 ADC).

As of the end of 2024, FibroGen's unaudited cash, cash equivalents, and accounts receivable totaled $1.211 billion.

Moreover, currently, regarding the investigation results of Wang Lei's case, AstraZeneca has not yet provided a clear conclusion. On February 6 local time, AstraZeneca released its 2024 financial report, which separately detailed the relevant situation of the Chinese market. Meanwhile, concerning the alleged illegal import of drugs, AstraZeneca stated that in January 2025, it received the "Notice of Referral for Prosecution" and the "Notice of Expert Opinion" issued by Shenzhen Customs. The expert opinion indicated that AstraZeneca was suspected of evading import duties, amounting to 900,000 US dollars.

AstraZeneca believes that, according to relevant information, the import duties mentioned in the "Appraisal Opinion Notice" involve Durvalumab (Imfinzi) and Tremelimumab (Imjudo); if AstraZeneca is ultimately found liable, it may also be fined one to five times the amount of evaded taxes (up to 4.5 million USD).

Interface News reporter |Huang Hua
Interface News Editor |Xie Xin

On February 20, AstraZeneca announced an agreement with FibroGen to acquire FibroGen China for approximately $160 million. According to the agreement, FibroGen will receive $85 million in enterprise value and approximately $75 million in cash held by FibroGen China at the time of closing, totaling about $160 million. The transaction is expected to be completed by mid-2025.

AstraZeneca and FibroGen have a long-standing partnership, and the current acquisition is AstraZeneca's first major move in China following the "Wang Lei controversy" and a series of subsequent high-level management upheavals in its China region.

Regarding the aforementioned transaction, Leo Lin, the newly appointed General Manager of AstraZeneca China, stated that this acquisition expands AstraZeneca's investment in China's pharmaceutical market. He emphasized the company’s commitment to bringing potentially life-saving innovative drugs to Chinese patients and supporting local innovative enterprises in their global development.

On the evening of October 30 last year, AstraZeneca announced that Leon Wang, Executive Vice President, Global Head of International Business, and President of China, was cooperating with an investigation in China. Two months later, AstraZeneca quickly filled the vacancy caused by Leon Wang's investigation.

That is, on the evening of December 4 last year, AstraZeneca announced a personnel appointment, declaring that Iskra Reic would serve as Executive Vice President, Global Head of International Business, fully responsible for regional operations including China, Asia and Eurasia, Middle East and Africa, Latin America, Australia, and New Zealand.

Subsequently, an internal letter released by Iskra Reic showed that Lin Xiao would serve as the General Manager of AstraZeneca China, reporting directly to Iskra Reic. Currently, the official website information shows that Lin Xiao serves as the General Manager of AstraZeneca China and the General Manager of AstraZeneca China's biopharmaceutical business.

In the product, after the completion of the delivery, AstraZeneca will obtain all rights to Roxadustat Capsules (Chinese trade name: Ai Rui Zhuo) in China, and FibroGen will retain its rights to Roxadustat in the United States and markets not authorized to Astellas Pharma.

Roxadustat is a special and controversial product in the pharmaceutical industry. Its uniqueness lies in being the world's first hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), a discovery that won the 2019 Nobel Prize in Physiology or Medicine. It is also the first new drug in China's renal anemia field in 30 years.

Moreover, on a global scale, China was the first country to approve the launch of Roxadustat. This is also the first global new drug developed by a foreign pharmaceutical company that was launched in China before anywhere else. On December 17, 2018, the product was approved for marketing by the National Medical Products Administration (NMPA) through an expedited priority review and approval process, and it was industrially produced in Beijing for treating anemia caused by chronic kidney disease (CKD). Both dialysis and non-dialysis patients can take this medication.

However, due to safety concerns, the approval process of roxadustat overseas has been very tortuous. In July 2021, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) voted against the approval of roxadustat (Roxadustat) for the treatment of anemia in chronic kidney disease (CKD) patients. The voting result for CKD anemia patients on dialysis was 12:2, and for non-dialysis CKD anemia patients, it was 13:1. Subsequently, the FDA rejected the drug's application for marketing in the United States.

In addition, the authorized regions for Astellas' roxadustat include Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. To date, roxadustat has been approved in Europe, Japan, and other countries for the treatment of anemia in chronic kidney disease (CKD) patients who are on dialysis or not on dialysis.

Unlike the situation overseas, roxadustat not only hit the Chinese market early but also became a commercially successful drug. According to data from Menet, the sales of roxadustat capsules in urban public hospitals in China reached 1.397 billion yuan in 2023. Moreover, since 2020, roxadustat has consistently ranked first in China's renal anemia market. This success is also due to AstraZeneca's influence in the Chinese market.

Currently, the development of Roxadustat in China is still ongoing. According to FibroGen's official website, the indication of Roxadustat for treating chemotherapy-induced anemia (CIA) has entered Phase 3 clinical trials in China. Regarding the progress in treating chemotherapy-induced anemia, Lin Xiao mentioned in today’s speech that AstraZeneca looks forward to a regulatory decision on Roxadustat for treating chemotherapy-induced anemia by early 2025.

On the other hand, FibroGen's situation is not good. Last July, FibroGen announced that it would cut about 75% of its U.S. workforce and halt the development of the CTGF inhibitor pamrevlumab. This also means that selling its China assets and only commercialized drug to AstraZeneca could be used as a stopgap measure.

As of the end of 2024, FibroGen's unaudited cash, cash equivalents, and accounts receivable totaled $1.211 billion.

Moreover, currently, regarding the investigation results of Wang Lei's case, AstraZeneca has not yet provided a clear conclusion. On February 6 local time, AstraZeneca released its 2024 financial report, which separately elaborated on the relevant situation of the Chinese market. Meanwhile, concerning the alleged illegal import of drugs, AstraZeneca stated that in January 2025, it received the "Notice of Transfer for Review and Prosecution" and the "Notice of Appraisal Opinion" issued by Shenzhen Customs. The opinion indicated that AstraZeneca was suspected of evading import taxes, with an amount reaching 900,000 US dollars.

AstraZeneca believes that, according to relevant information, the import taxes mentioned in the "Appraisal Opinion Notice" involve Durvalumab (Imfinzi) and Tremelimumab (Imjudo); if AstraZeneca is ultimately found liable, it may also be fined one to five times the amount of evaded taxes (up to 4.5 million USD).

Image source: Visual China

Interface News reporter |Huang Hua
Interface News Editor |Xie Xin

On February 20, AstraZeneca announced an agreement with FibroGen to acquire FibroGen China for a consideration of approximately $160 million. According to the agreement, FibroGen will receive an enterprise value of $85 million and approximately $75 million in cash held by FibroGen China at the closing of the transaction, totaling approximately $160 million. The transaction is expected to be completed by mid-2025.

AstraZeneca and FibroGen have a long-standing partnership, and the current acquisition is AstraZeneca's first major move in China following the "Wang Lei controversy" and a series of subsequent high-level management changes in its China region.

On the evening of October 30 last year, AstraZeneca announced that Leon Wang, Executive Vice President, Global, Chair of International Business, and President of China, was cooperating with an investigation in China. Two months later, AstraZeneca quickly filled the vacancy caused by Leon Wang's investigation.

On the evening of December 4 last year, AstraZeneca announced a personnel appointment, stating that Iskra Reic would serve as Executive Vice President, Global Head of International Business, fully responsible for regional operations including China, Asia and Eurasia, Middle East and Africa, Latin America, Australia, and New Zealand.

Subsequently, an internal letter released by Iskra Reic revealed that Xiao Lin will assume the role of General Manager of AstraZeneca China, reporting directly to Iskra Reic. Currently, the official website indicates that Xiao Lin serves as the General Manager of AstraZeneca China and the General Manager of AstraZeneca China’s biopharmaceutical business.

In terms of the product, upon completion of the delivery, AstraZeneca will acquire all rights to roxadustat capsules (Chinese trade name: Ai Rui Zhuo) in China, while FibroGen will retain its rights to roxadustat in the United States and markets not licensed to Astellas Pharma.

Moreover, on a global scale, China was the first country to approve the launch of Roxadustat, marking the first time a new drug developed by a foreign pharmaceutical company was launched in China before anywhere else in the world. On December 17, 2018, the product received approval for marketing through the National Medical Products Administration’s priority review and approval process, and was industrially produced in Beijing for treating anemia caused by chronic kidney disease (CKD), suitable for both dialysis and non-dialysis patients.

However, due to safety concerns, the approval process of Roxadustat overseas has been very tortuous. In July 2021, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) voted against the approval of Roxadustat for the treatment of anemia in chronic kidney disease (CKD) patients. The voting results were 12 to 2 for CKD patients with dialysis and 13 to 1 for CKD patients without dialysis. Subsequently, Roxadustat's market application in the United States was rejected by the FDA.

More than two years after being rejected by the FDA, the overseas commercial rights of Roxadustat have also changed. AstraZeneca has returned the rights of Roxadustat in the United States and other regions of the world to FibroGen. The reason it is referred to as "returned" is that in 2013, FibroGen and AstraZeneca reached a cooperation agreement for the joint development and commercialization of Roxadustat in China, the United States, other markets in the Americas, Australia/New Zealand, and Southeast Asia.

In addition, the authorized regions for Astellas to obtain Roxadustat include Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa, among other markets. As of now, Roxadustat has also been approved in Europe, Japan, and other countries for the treatment of anemia in chronic kidney disease (CKD) patients who are on dialysis or not on dialysis.

Unlike the situation overseas, roxadustat not only entered the Chinese market early but also became a commercially successful drug. According to data from Menet, in 2023, the sales of roxadustat capsules in urban public hospitals in China reached 1.397 billion yuan. Additionally, since 2020, roxadustat has consistently ranked first in China's renal anemia market. This success is also attributed to AstraZeneca's influence in the Chinese market.

Currently, the development of Roxadustat in China is still ongoing. According to FibroGen's official website, the indication of Roxadustat for treating chemotherapy-induced anemia (CIA) has entered phase 3 clinical trials in China. Regarding the progress in treating chemotherapy-induced anemia, Lin Xiao mentioned in today’s speech that AstraZeneca looks forward to a regulatory decision on the use of Roxadustat for treating chemotherapy-induced anemia by early 2025.

As of the end of 2024, FibroGen's unaudited cash, cash equivalents, and accounts receivable totaled $1.211 billion.

Moreover, currently, regarding the investigation results of Wang Lei's case, AstraZeneca has not yet provided a clear conclusion. On February 6 local time, AstraZeneca released its 2024 financial report, which separately detailed the relevant situation of the Chinese market. Meanwhile, concerning the alleged illegal importation of drugs, AstraZeneca stated that in January 2025, it received the "Notice of Referral for Prosecution" and the "Notice of Appraisal Opinion" issued by Shenzhen Customs. The opinion indicated that AstraZeneca was suspected of evading import duties, with an amount reaching 900,000 US dollars.

Interface News reporter |Huang Hua
Interface News Editor |Xie Xin

AstraZeneca and FibroGen have a long-standing partnership, and the current acquisition is AstraZeneca's first major move in China following the "Wang Lei controversy" and a series of subsequent high-level management upheavals in its China region.

Regarding the aforementioned transaction, Leo Lin, the newly appointed General Manager of AstraZeneca China, stated that this acquisition expands AstraZeneca's investment in China's pharmaceutical market. He emphasized the company’s commitment to bringing potentially life-saving innovative drugs to Chinese patients and supporting local innovative enterprises in their global development.

On the evening of October 30 last year, AstraZeneca announced that Leon Wang, Executive Vice President, Global Head of International Business, and President of AstraZeneca China, was cooperating with an investigation in China. Two months later, AstraZeneca quickly filled the vacancy created due to Leon Wang's investigation.

That is, on the evening of December 4th last year, AstraZeneca announced a personnel appointment, declaring that Iskra Reic would serve as Executive Vice President, Global Head of International Business, fully responsible for regional operations including China, Asia and Eurasia, Middle East and Africa, Latin America, Australia, and New Zealand.

Subsequently, an internal letter released by Iskra Reic revealed that Lin Xiao will assume the position of General Manager of AstraZeneca China, reporting directly to Iskra Reic. Currently, the official website information shows that Lin Xiao serves as the General Manager of AstraZeneca China and the General Manager of AstraZeneca China's biopharmaceutical business.

Roxadustat is a special and controversial product in the pharmaceutical industry. Its uniqueness lies in being the world's first hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), a technology discovery that won the 2019 Nobel Prize in Physiology or Medicine. It is also the first new drug in China's renal anemia field in 30 years.

Moreover, on a global scale, China was the first country to approve the launch of Roxadustat. This is also the first global new drug developed by a foreign pharmaceutical company that achieved its first market launch in China. On December 17, 2018, the product was approved for marketing by the National Medical Products Administration (NMPA) through a priority review and approval process, and it was industrialized in Beijing for the treatment of anemia caused by chronic kidney disease (CKD). Both dialysis and non-dialysis patients can take it.

However, due to safety concerns, the approval process of roxadustat overseas has been very tortuous. In July 2021, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) voted against the approval of roxadustat (Roxadustat) for the treatment of anemia in chronic kidney disease (CKD) patients. The voting results were 12 to 2 for CKD patients with anemia on dialysis and 13 to 1 for CKD patients with anemia not on dialysis. Subsequently, the application for roxadustat to be marketed in the United States was rejected by the FDA.

More than two years after being rejected by the FDA, the overseas commercial rights to roxadustat have also changed. AstraZeneca has returned the rights to roxadustat in the United States and other regions of the world to FibroGen. The reason it is referred to as "returned" is that in 2013, FibroGen and AstraZeneca reached a cooperation agreement for the joint development and commercialization of roxadustat in China, the United States, other markets in the Americas, Australia/New Zealand, and Southeast Asia.

In addition, the authorized regions for Astellas to obtain Roxadustat include Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa, among other markets. As of now, Roxadustat has also been approved in Europe, Japan, and other countries for the treatment of anemia in both dialysis and non-dialysis patients with chronic kidney disease (CKD).

Unlike the situation overseas, roxadustat not only entered the Chinese market early but also became a commercially successful drug. According to data from Menet, in 2023, the sales of roxadustat capsules in urban public hospitals in China reached 1.397 billion yuan. Additionally, since 2020, roxadustat has consistently ranked first in China's renal anemia market. This success is also due to AstraZeneca's influence in the Chinese market.

Currently, the development of Roxadustat in China is still ongoing. According to FibroGen's official website, the indication for Roxadustat in treating chemotherapy-induced anemia (CIA) has entered Phase 3 clinical trials in China. Regarding the progress in treating chemotherapy-induced anemia, Lin Xiao mentioned in today’s speech that AstraZeneca anticipates a regulatory decision on the use of Roxadustat for treating chemotherapy-induced anemia by early 2025.

On the other hand, FibroGen's situation is not good. Last July, FibroGen announced that it would cut about 75% of its U.S. workforce and halt the development of the CTGF inhibitor Pamrevlumab. This also means that selling its China assets and only commercialized drug to AstraZeneca can be used as a stopgap measure.

As of the end of 2024, FibroGen's unaudited cash, cash equivalents, and accounts receivable totaled $1.211 billion.

Moreover, currently, regarding the investigation results of Wang Lei's case, AstraZeneca has not yet provided a clear conclusion. On February 6 local time, AstraZeneca released its 2024 financial report, which separately detailed the relevant situation of the Chinese market. Meanwhile, concerning the alleged illegal importation of drugs, AstraZeneca stated that in January 2025, it received the "Notice of Transfer for Review and Prosecution" and the "Notice of Expert Opinion" issued by Shenzhen Customs. The expert opinion indicated that AstraZeneca was suspected of evading import duties, amounting to 900,000 US dollars.