The Net Profit Attributable to Shareholders Increased 13.1% as Compared to the Same Period in 2019 with Innovation Transformatio

2020-08-27 17:00

(26 August, 2020, Shanghai)25 August, 2020, Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma"; Stock Code: 600196.SH, 02196.HK), a leading healthcare group in China, announced its interim results for the year 2020 ("the Reporting Period").

 

During the Reporting Period:

The revenue achieved RMB 14,028 million; 

The net profit attributable to shareholders of the listed company amounted to RMB 1,715 million, representing a respective increase of 13.1%;

The net profit attributable to shareholders of the listed company after deduction of non-recurring amounted to RMB 1,304 million, representing a respective increase of 11.71%.

 

Wu Yifang, President and CEO of Fosun Pharma, expressed that "the COVID-19 brings relatively huge influence and uncertainty to the global and China’s economy. In the first half of 2020, with the orderly work resumption, the production and operation resumed in Q2. The operating revenue in Q2 increased by 38.6% compared with Q1. On the basis of properly carrying out the existing business and industrial upgrading, Fosun Pharma is firmly committed to the path of innovation and international development, thereby maintaining the long-term growth of our performance.”

Actively promoted innovation transformation and strengthened the global R&D system together with the capacity building of pharmaceuticals

Fosun Pharma continues to be guided by innovation and internationalization, vigorously develop strategic products, improve the "Combination of integrates biosimilars and innovative drugs" R&D system, and further strengthen R&D investment. In the first half of 2020, Fosun Pharma invested RMB 1,689 million in R&D, an increase of 25.02% compared to the same period last year, of which the R&D expenditure was RMB 1,204 million, an increase of 41.81% compared to the same period in 2019. As of the end of the Reporting Period, Fosun Pharma had 248 pipeline innovative drugs, generic drugs, biosimilars and consistency evaluation projects of generic drugs.

In order to strengthen the global R&D system and capacity building of pharmaceuticals, Fosun Pharma established the Global R&D Center in early 2020, which is responsible for the overall management of the Group's innovative R&D projects. Focusing on China, the United States and Europe to strengthen preclinical drug research, the ability of clinical development and transforming medicine. Currently, Fosun Pharma has already established interactive and integrated R&D systems in China, the United States and India, and created international R&D platforms including biological drugs, small molecular innovative drugs, high-value generic drugs, new technology therapy.

In the Reporting Period, sales of Rituximab injection (汉利康®) increased rapidly after the approval of the new production scale (2,000L), with revenue of RMB 224 million in the first half of the year and more than RMB 100 million revenue in June; Avatrombopag maleate tablets (苏可欣®), the first licensed drug for selective thrombocytopenia treatment of adult patients with chronic liver disease undergoing diagnostic procedures or surgery had been approved to market. As of the end of the Reporting Period, Fosun Pharma has obtained approval for clinical trial in Chinese Mainland on 10 small molecule innovative products (including 1 improved new drug) and 11 indications; as well as approval for overseas clinical trials for 5 small molecule innovative drugs and 5 indications. In particular, ORIN1001 had launched phase I clinical trials in the U.S. and recognized by the U.S. Food and Drug Administration (‘‘U.S. FDA’’) under the Fast Track Development Program. SAT-189 had been approved to phase II clinical trials in the U.S.; and 10 monoclonal antibody products and 8 combination therapies had launched more than 20 clinical trials worldwide; Axicabtagene Ciloleucel (code FKC876, i.e. anti-human CD19 CAR-T cell injection) of Fosun Kite, a joint venture, completed the bridging clinical trial of the Product for the treatment of adult patients with relapsed and refractory large B-cell lymphoma in Chinese Mainland and commenced clinical trials in Chinese Mainland and was granted priority review status for the launch and registration of drugs. During the Reporting Period, the subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (“Fosun Pharmaceutical Industrial”) was approved to conduct clinical trial in Chinese Mainland by the National Medical Products Administration (the “NMPA”) for the mRNA-based COVID-19 vaccine candidate which had been approved by BioNTech.

Integrated operation, improved efficiency and steady international development

Fosun Pharma adheres to actively promote the development of innovation field. Meanwhile, Fosun Pharma continues to strengthen the construction and integration of the marketing system, and the marketing mode is transformed towards specialization, branding and digitalization. Fosun Pharma has formed a domestic and foreign marketing network and marketing team matched with the existing products and products to be listed on the market. In particular, domestic marketing has built a strong ability and management system in the field of high-end diagnosis and treatment of hematological tumors. By the end of the Reporting Period, Fosun Pharma had formed a marketing team of nearly 5,800 people, and nearly 1,000 staff for overseas drugs and medical devices are included. In the field of drug and device distribution and retailing, Fosun Pharma gives full play to the advantages of Sinopharm's distribution network and logistics through cooperation and linkage with Sinopharm Industrial Investment Co., Ltd. to promote the expansion of drug sales channels of Fosun Pharma.

During the Reporting Period, Fosun Pharma achieved RMB 4,071 million operating revenue, accounting for 29.02% of the total. In terms of international expansion, Fosun Pharma not only established subsidiaries and developed its operating capability in mature markets such as the US and Europe, but also developed markets and production capacity through self-development and M&A in emerging markets such as Africa and India. Meanwhile, Fosun Pharma further consolidated its competitiveness in the African market, build marketing platforms in the United States and Europe, promoted in-depth cooperation with multinational pharmaceutical companies, and increased the drug sales scale of Fosun Pharma in the international market.

Fought against the COVID-19 with science and technology to practice social responsibility

In the first half of 2020, in the face of the unexpected COVID-19 pandemic, Fosun Pharma fully combined its own business characteristics and global resource advantages, quickly respond to the epidemic and actively assumed social responsibility during the process of fighting the COVID-19.

In order to meet the needs of medical materials for epidemic prevention and control in time, Fosun Pharma joined hands with global member enterprises to ensure the research, development, procurement and production of medical materials. In particular, the independently-developed 2019-nCoV nucleic acid detection kit (PCR) passed the emergency examination and obtained the approval of the National Medical Products Administration (NMPA) and the medical device registration certificate (in vitro diagnostic reagent). A number of COVID-19 test kits have obtained the relevant qualifications and certification from the United States, the European Union, Australia and other countries and regions. In addition, Fosun Pharma also actively cooperates with BioNTech in Germany to develop mRNA vaccine, undertake the production of national negative pressure ambulances, produce and dispatch global supply of ventilators, and provide mobile CT innovative medical equipment to help reduce the risk of multi-department cross-infection caused by patient transfer.

As of the Reporting Period, the cumulative value of cash or medical masks, protective clothing, medical non-invasive ventilators, negative pressure ambulances and other medical equipment and daily necessities donated by Fosun Pharma to the epidemic area had exceeded RMB 30 million. In Wuhan, Wuhan Jihe Hospital, a designated medical institution under COVID-19, cured 515 patients, with a mortality rate of 0 and an infection rate of 0 for medical personnel.

Looking forward to the second half of 2020, Chen Qiyu, Co-CEO of Fosun International and Chairman of Fosun Pharma, said that " The nationwide COVID-19 prevention and control is now being conducted on an ongoing basis, and Fosun Pharma will continue to take various measures to ensure stable and orderly production and management activities on the basis of fully absorbing the experience of work resumption and fighting epidemic in the first half of the year. Fosun Pharma will adhere to the development mode of ‘innovation transformation, integrated operation and steady growth’, stick to actively promote the development of the innovation field, and strive to achieve innovation transformation in the short-and-medium term; at the same time, Fosun Pharma will maintain a steady international development, making itself more internationally competitive in operating standards and market expansion. "

 

F A Q
Is it legal for manufacturers to cope with issues of initial registration without an agent ?

 

 

Unfortunately, it is NOT legal unless the manufacturers have branches with qualification in China to deal with the registration issues. Otherwise, it is a must-do that manufacturers overseas are required to appoint a Chinese agent for the medical device registration.

In terms of the initial registration for market entry of mainland China, what is the registration fee needed ?

 

 

Regarding the registration fee for NMPA, as for the imported medical devices, the registration of Class II medical device needs 210,900 CNY while that of Class III costs 308,800 CNY. In addition, other kinds of possible fees should be taken into consideration such as fees of document translation, clinical trial, and so forth.

 

How long is the NMPA review process for the initial registration of the medical device ?

 

 

After the registration materials are accepted by NMPA, technical review for Class II medical devices takes 60 working days to process while for Class III medical devices, technical review takes 90 working days. If supplementary materials are required by NMPA, manufacturers are obliged to conduct submission within one year, otherwise the review may result in termination.

 

Is it possible for a medical device with CE or FDA certificate to enter SAR (HK/MO) and pilot area such as Hainan and the Greater Bay Area ?

 

 

MDs with CE or FDA certificate are feasible to enter SAR without NMPA certificate. As for the Greater Bay Area and Hainan province, MDs marketed in HK or MO as a premise can enter the pilot areas if designated medical institutions in pilot areas are willing to procure medical devices out of clinical urgent needs under the approval of local government.

 

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