中国首发！合全药业祝贺合作伙伴珐博进（FibroGen）First in Class 新药罗沙司他正式在国内获批

中国首发！合全药业祝贺合作伙伴珐博进（FibroGen） First in Class 新药罗沙司他正式在国内获批

China Starter! WuXi STA congratulates partner FibroGen First in Class new drug Roxadustat was officially approved in China

近日，合全药业的合作伙伴迎来重磅喜讯。国家药品监督管理局宣布，由珐博进（FibroGen）研发的罗沙司他（roxadustat，商品名为爱瑞卓）正式在中国获批，用于治疗正在接受透析治疗的患者因慢性肾脏病(CKD)引起的贫血。该新药目前尚未在其他任何国家上市。这是合全药业合作伙伴珐博进优先为中国患者打造的一款First in Class新药。

值得一提的是，早在2011年合全药业就开始了与珐博进的合作，从实验室工艺优化到开发稳定的商业化生产工艺，并提供大批量的原料药API支持临床研究，合全药业为珐博进的成功获批提供了全方面的支持。依托合全这个赋能的平台，罗沙司他成为一类创新药中第一个中国获批先于国外的案例。

罗沙司他是一种低氧诱导因子脯氨酰羟化酶（HIF-PH）抑制剂，可抑制HIF的泛素化降解，帮助机体产生更多的红血球，开发用于治疗CKD患者的贫血。肾性贫血为慢性肾脏病（CKD）肾功能失代偿期主要并发症之一。随着CKD的进展，CKD相关贫血的患病率和严重程度逐渐增加。肾性贫血患者较常规贫血难以纠正，患者乏力严重，生活质量低下。无论是透析还是非透析CKD患者，发病率和死亡率都非常高。CKD可发病于任何年龄，老年人中更为常见。有数据统计，中国大约有1.195亿CKD患者。中国接受透析的CKD人群超过40万，而且以两位数的增幅快速增长，因此需要抗贫血疗法的患者日益增多。

目前肾性贫血的标准治疗方法为促红细胞生成素（EPO激素）替代，阿法依伯汀等红细胞生成刺激剂（ESA）并加静脉铁剂，皮下注射给药，可有效升高CKD患者血红蛋白（Hb）含量，改善临床症状。而口服药物罗沙司他胶囊是全球首个开发的小分子低氧诱导因子脯氨酰羟化酶抑制剂（HIF- PHI）类治疗肾性贫血的药物。低氧诱导因子(HIF)的生理作用不仅使红细胞生成素表达增加，也能使红细胞生成素受体以及促进铁吸收和循环的蛋白表达增加。罗沙司他通过模拟脯氨酰羟化酶（PH）的底物之一酮戊二酸来抑制PH酶，影响PH酶在维持HIF生成和降解速率平衡方面的作用，从而达到纠正贫血的目的。罗沙司他胶囊的上市将为因慢性肾脏病引起的贫血患者提供了新的治疗手段。

“我们祝贺珐博进的罗沙司他在中国首发上市，这对中国创新药行业有着非同寻常的意义。我们希望这款药物能够造福贫血患者，给更多患者带来新的治疗选择。更希望越来越多的合作伙伴能够依托合全这个赋能的平台实现创新药快速上市。”合全药业首席执行官陈民章博士表示。

China Starter! WuXi STA congratulates partner FibroGen First in Class new drug Roxadustat was officially approved in China

WuXi STA's partner ushered in the heavyweight news. Just now, the National Medical Products Administration (NMPA) announced that Rosha (Roxadustat, commercial name AiRuiZhuo), developed by (FibroGen), was officially approved in China for the treatment of anemia caused by chronic kidney disease (CKD) in patients undergoing dialysis treatment. Roxadustat is not currently on the market in any other country. This is a first in class new drug created by our partner FibroGen, with priority for Chinese patients.

It is worth mentioning that as early as 2011, WuXi STA began to cooperate with FibroGen, from laboratory process optimization to the development of stable commercial production processes, and to provide a large number of APIs to support clinical research, WuXi STA provided all around support for FibroGen’s successful approval. With WuXi STA support, Roxa became the first first-in-class innovative drug to be approved in China before any other country.

Roxa is a hypoxic-inducing factor (HIF-PH) inhibitor that inhibits ubiquitin degradation of HIF, helps the body produce more red blood cells, and develops treatment for anemia for patients with CKD. Renal anemia is one of the main complications of chronic renal disease (CKD) during renal dysfunction. With the progress of CKD, the prevalence and severity of CKD related anemia gradually increased. Patients with renal anemia are more difficult to correct than conventional anemia, patients with severe weakness and low quality of life. Morbidity and mortality rates are very high for both dialysis and non-dialysis patients with CKD. CKD can occur at any age and is more common in the elderly. Some data indicate that, there are about 119.5 million CKD patients in China, with more than 400,000 of the CKD population undergoing dialysis in China, which is experiencing double-digit rapid growth. Therefore, there is a growing number of patients in need of anti-anemia therapy.

At present, the standard treatment method of renal anemia is erythropoietin (EPO hormone) substitution, Alfa epoietin and other erythrocyte stimulating agent (ESA) and intravenous iron, subcutaneous injection, can effectively increase the content of hemoglobin (Hb) in patients with CKD, improve clinical symptoms.The oral drug, is the world's first development of a small molecule hypoxic-inducing factor proline inhibitor (HIF-PHI) in the treatment of renal anemia drugs. The physiological effects of hypoxic-inducing factor (HIF) not only increase the expression of erythropoietin, but also increase the expression of erythropoietin receptor and protein to promote iron absorption and circulation. Roxa inhibits ph enzymes by simulating one of the substrates of proline (ph), which affects the role of ph enzymes in maintaining HIF formation and degradation rate balance, so as to correct anemia. The listing of the capsule will provide new treatments for patients with anemia caused by chronic kidney disease.

"We congratulate Roxadustat on its debut in China, which is of extraordinary significance to China's innovative pharmaceutical industry. We hope this drug will benefit anemia patients and provide new treatment options to more patients. We further hope that more hope that more and more of our partners can rely on our enabling platform to achieve the rapid launch of innovative drugs.” Dr. Minzhang Chen, CEO of WuXi STA, said.