Text . . Linan accelerates priority review and approval of innovative drugs, establishes a list of new drugs that are clinically urgently needed abroad... In recent years, with the reform of China's drug review and approval system, more and more global innovative drugs have accelerated their entry into the Chinese market.
Against the background of encouraging pharmaceutical innovation, speeding up the introduction of new drugs, and purifying the business environment, the Chinese pharmaceutical market is becoming more and more popular with multinational pharmaceutical companies, which have set up factories in China and invested more in scientific research, and so on, while how to quickly promote more innovative drugs to the market to meet the needs of more patients, is also a close concern of pharmaceutical giants.
signing ceremony on december 16th, ahead of the upcoming launch of a new drug for leukemia in China, Astellas announced that it would work with Baiyang Pharmaceuticals to deepen its cooperation and that Baiyang would work together for XOSPATA® (english generic name: gilteritinib fumarate tablets, Chinese The common name: Fumarate Gilitini tablets) provide integration from import bonded customs clearance and warehousing logistics, as well as across-channel commercial platform solutions to comprehensively improve the access to medicines for adult patients with FLT-3 mutated acute myeloid leukemia (AML).
2018, XOSPATA ® in Japan and the United States, and in Europe in 2019.
In April this year, China's State Drug Administration accepted the registration application for the listing of new drugs of XOSPATA®, in July, the application for a new drug listing license was included in the priority review, and in November entered the third batch of clinically urgent need for new drugs abroad list, the industry expects XOSPATA® is expected to be listed in China next year Q1.
XOSPATA® is a drug discovered by Astellas in collaboration with Kotobuki Pharmaceuticals, Inc., which has exclusive rights to develop, manufacture and commercialize Ginetinib globally.
the drug is used to treat adult patients with recurring or incurable acute myeloid leukemia (AML) with FLT3 mutations.
, acute myeloid leukemia is a tumor that affects the blood and bone marrow, and its incidence increases with age.
AML is one of the most common types of leukemia in adults.
statistics, about 80,000 people in China are diagnosed with leukemia every year.
In the past ten years, the treatment of recurring incurable acute myeloid leukemia has been slow, with short survival and many complications, except for resurrive chemotherapy and hematopoietic stem cell transplantation.
with acute myeloid leukemia who tested positive for the FLT3 mutation had a very poor prognostication, saving the median survival after chemotherapy for less than six months.
the status of the FLT3 mutation may change during the treatment of acute myeloid leukemia, even after recurrence.
therefore, confirming the mutation status of the patient FLT3 can help determine the best treatment.
As FMS-like tyrosine kinase 3 (FLT3), two common FLT3 mutations, FLT3-ITD and FLT3-TKD, were found in about one-third of patients with acute myeloid leukemia.
study by XOSPATA, researchers compared the overall survival rate of 247 patients who took XOSPATA with those who received chemotherapy among those who had relapsed or did not improve after chemotherapy.
results showed that patients taking XOSPATA had a median OS for 9 months, while patients receiving chemotherapy had a median of 15 months for complete remission and a median of 2 months for chemotherapy.
For Therettinib to be included in the priority review qualification and included in the list of clinically in urgent need of new drugs abroad, Astellas Pharmaceuticals (China) Co., Ltd. Chairman and General Manager Binkou Yang said that this has encouraged them, but also deeply felt that with the continuous optimization of China's drug review and approval system, the speed of the introduction of new drugs has been greatly improved.
As early as March 2019, Astellas has worked with Baiyang for the first time to help Astellas' tansorosin hydrochloric acid slow release capsule (commodity name: Halle) accelerate the introduction into retail terminals and improve the quality of life of patients with benign prostate hyperplision (BPH) by further expanding patient access to high-quality drugs.
2020, the two sides reached a strategic partnership on their long-term treatment for high uric acidemia with gout symptoms.
a series of pharmaceutical policies catalytic, China's pharmaceutical industry structure intensified adjustment and change, it is not difficult to predict that future innovation is the core competitiveness of pharmaceutical enterprises, at the same time cost control is also very important.
era of high gross margin is over, after which the threshold for the commercialization of Chinese medicine is expected to be higher and higher.
can see that Astellas once again with Baiyang Pharmaceuticals, but also to see its commercial platform of the unique "charm."
It is also worth mentioning that at the ninth meeting of the Cpc Central Committee on Comprehensive And Deepening Reform in 2019, the General Plan for the Construction of the China-SHANGHAI Cooperation Organization Demonstration Zone for Local Economic and Trade Cooperation was adopted, in order to build a new platform for "Belt and Road" international cooperation in Qingdao, Shanghai and the Demonstration Zone, and promote the opening pattern of East-West two-way mutual assistance and land-to-sea linkage.
As a leading private enterprise in The Pharmaceutical Industry in Qingdao, Baiyang Pharmaceuticals actively integrates into the national strategy of the new platform of international cooperation in the Belt and Road, with perfect drug import qualification and customs AEO certification qualification, showing its strong overseas drug import business strength.
it is learned that whether it is import bonded customs clearance, cold chain warehouse or efficient logistics and distribution, Baiyang has a professional import operation team to carry out full-process services for overseas drugs to unblock international logistics channels.
future, through air and sea transport, directly from Japan from Qingdao port into China, for enterprises to improve efficiency and reduce costs, for Qingdao City to build the Shanghai demonstration zone to contribute.
break through the traditional brand-type corporate image in everyone's mind, today's Baiyang Pharmaceuticals continue to forge ahead, committed to become China's pharmaceutical industry downstream of the largest third-party professional pharmaceutical commercial platform, to build a health brand highway.
Based on 15 years of accumulation in the deep-farming industry, Baiyang now has a strong marketing network, through 3D coverage, multi-category collaboration and digital marketing differentiation capabilities, can provide upstream industrial enterprises with 3D solutions to help good products and services quickly into the application scenario.
Baiyang commercialization platform can not only help the original research drugs in the retail channels to release brand value, as well as medical products and other large health brands of new retail operations, but also to promote the rapid entry of new special drugs into the market, for pharmaceutical companies to optimize costs, improve efficiency, promote industry development.
with its increasingly plump commercial platform, Baiyang has attracted many partners in recent years, such as Meilan, Xi'an Yangsen, Takeda, Jet Bellin, Sansheng Pharmaceuticals and others.