Novo Nordisk Launches Novoeight® in China and Initiates 'Yi Sheng Shou Hu' Hemophilia A Patient Assistance Program

(Hangzhou, July 31, 2021) Today, NovoEight® (Recombinant Human Coagulation Factor VIII for Injection), developed and manufactured by Novo Nordisk,^®Officially launched in China for the treatment of hemophilia A in adults and children.

On the same day, the "Yisheng Guardian Hemophilia A Patient Assistance Program" was simultaneously launched, aiming to assist patients receiving Novo^®Provides financial assistance to hemophilia patients undergoing treatment and meeting relevant criteria, supporting them in receiving standardized and sustainable treatment to facilitate their healthy reintegration into society. This assistance program is initiated and operated by the China Primary Health Care Foundation and the Beijing Institute of National Health Medicine, with charitable support from Novo Nordisk.

Hemophilia is an X-linked recessive inherited bleeding disorder, which can be classified into Hemophilia A and Hemophilia B.¹, once it manifests, it becomes a lifelong condition. "Individuals who bleed uncontrollably after an injury and cannot withstand even minor impacts, known as 'glass people'"... Public awareness of hemophilia is merely the tip of the iceberg. Beyond trauma-induced bleeding, patients with severe hemophilia may experience spontaneous bleeding from early childhood.¹。According to a survey across 24 provinces in China from 1986 to 1989, the prevalence of hemophilia in China was approximately 2.73 per 100,000 population1, with clinical manifestations primarily characterized by bleeding into the joints, muscles, and deep tissues.¹, if not treated promptly, may lead to disability, and in severe cases, may even be life-threatening.

《Chinese Guidelines for the Treatment of Hemophilia (2020 Edition)》 states that recombinant factor VIII products or virally inactivated plasma-derived factor VIII products are the preferred replacement therapy for hemophilia A.¹Professor Yang Renchi, Director of the Center for Thrombosis and Hemostasis at the Institute of Hematology & Blood Diseases Hospital (Institute of Hematology), Chinese Academy of Medical Sciences, and Head of the China Hemophilia Collaborative Group, stated: “Coagulation factor replacement therapy is currently the primary treatment modality for hemophilia. Prophylactic treatment involves the regular infusion of coagulation factors to prevent bleeding, aiming to prevent disability to the greatest extent.” However, standardized prophylactic treatment has not yet been widely adopted in China, and hemophilia patients continue to face challenges such as low diagnosis rates, poor treatment adherence, and high disability rates. The “Yi Sheng Guardian Hemophilia A Patient Assistance Program” provides patients with a convenient one-stop application process. Patients can apply for assistance through partner hospitals, pharmacies, or related applications, helping to alleviate the financial burden on hemophilia patients and promote active, standardized treatment.

During treatment, the risk of inhibitor development remains one of the major therapeutic challenges for hemophilia patients. In recent years, the incidence of inhibitors in hemophilia patients has shown an increasing trend.², increases the difficulty of treatment, and also increases the disability and mortality rates among patients.³. The third-generation recombinant human coagulation factor VIII, NovoEight®, is produced via genetic recombination technology using Chinese hamster ovary (CHO) cells. This product is a B-domain deleted recombinant human coagulation factor VIII; its activated form is similar to endogenous coagulation factor VIII, ensuring procoagulant activity. It is worth mentioning that NovoEight^®A five-step purification process is utilized to enhance product purity and reduce the risk of pathogen transmission. Results from multiple Guardian clinical trials demonstrate that the inhibitor incidence in previously treated patients (PTPs) is 0.⁴。

Professor Yang Renchi stated: "NovoEight^®Extensive efficacy and safety data for the prevention and treatment of bleeding have been accumulated globally. Nuoyi, marketed in China,^®, providing a new treatment option for adult and pediatric patients with hemophilia A. The Phase 3 clinical trial Guardian 7 conducted in China⁵It is China's first study to prospectively evaluate the efficacy of prophylactic treatment with rFVIII in hemophilia patients across all age groups in China.⁶, Novo^®100% efficacy rate for intraoperative and postoperative hemostasis⁷，it has a favorable safety profile and can help patients achieve better treatment outcomes.”

Nuoyi^®is the second hemophilia drug developed by Novo Nordisk, following the first hemophilia drug, NovoSeven^®(Recombinant Human Coagulation Factor VIIa for Injection) was launched globally in 1996, with cumulative usage reaching 5.4 million doses.⁸。Novo Nordisk’s journey to transform hemophilia care began in 1985—supporting Dr. Ulla Hedner’s pioneering hemophilia drug research and extending full commitment to the 3,500 hemophilia patients worldwide at that time. Over the past three decades, Novo Nordisk has remained steadfastly patient-centric, continuously innovating and developing safe and effective therapies, while consistently expanding access to help patients reclaim healthy lives.

In recent years, with the continuous improvement of medical insurance policies, China's hemophilia treatment and coverage system has made significant progress. Mr. Guan Tao, Chairman of the Beijing Hemophilia Home Rare Disease Care Center, stated: “We are deeply grateful for the support and assistance provided to hemophilia patients through national policies, social charity, and corporate innovation. The treatment of hemophilia has essentially achieved a ‘pain-free’ state. In the future, we hope that more hemophilia patients will receive standardized prophylactic treatment and return to a normal life!”

Zhou Xiaping, Executive Vice President and President, Greater China at Novo Nordisk, stated: "As a global leader in biopharmaceuticals, we are pleased to introduce Nuoyi^®Brought to China, it will provide more effective and safer treatment options for patients with hemophilia A in China. To address the unmet patient needs in the field of hemophilia, Novo Nordisk will continue to innovate and consistently deliver new treatment options to meet the evolving therapeutic needs of hemophilia patients. We look forward to collaborating with stakeholders across all sectors to meaningfully improve the quality of life for hemophilia patients!”

Recently, Novo Nordisk^®China's first prescription has officially been issued in Shanghai, and it is expected to bring greater clinical benefits to patients with Hemophilia A in China.

Reference Source:

1. Thrombosis and Hemostasis Group, Hematology Branch, Chinese Medical Association, China Hemophilia Collaboration Group. Chinese Journal of Hematology, 2017, 38(5):364-370.

2. Thrombosis and Hemostasis Group, Chinese Society of Hematology, Chinese Medical Association, Chinese Hemophilia Collaboration Group. Chinese Journal of Hematology, 2018, 39(10): 793-799.

3. Wang Shixuan, Yang Renchi. Progress in Research on Hemophilia A Inhibitors [J]. Chinese Journal of Hematology, 2017, 38(5): 444-448.

4. Package Insert for Recombinant Human Coagulation Factor VIII for Injection (Dated December 29, 2020)

Thim L, et al. Haemophilia 2010;16:349–59.

Christiansen MLS, et al. Haemophilia 2010;16:878–87.

Ellgaard T W, et al. Protein Expression and Purification, 2016, 129.

Lentz SR et al. Haemophilia 2018; 24:e391–e394.

Wu R, et al. Ther Clin Risk Manag. 2020;16:567-578.

CarmenEscuriola-Ettingshausen, et al. 2021 EAHAD,Abstract ABS210

5.Wu R, et al. TherClin Risk Manag. 2020;16:567-578.

6. At the time of initiation, this was the first prospective study in China to evaluate the efficacy of rFVIII prophylaxis in patients across all age groups in China, and its design complied with the European Medicines Agency guideline on the clinical development of FVIII products.

7.8 Treatment Efficacy Records for Surgical Cases

8. Overall rFVIIa exposure across all approved indications from January 1, 1996, to December 31, 2016. Total exposure was calculated based on the number of standard doses—defined as 90 μg/kg for an average individual body weight of 40 kg. Reference: Neufeld EJ et al. Haemophilia 2018;24:e275–e277.

About the China Primary Health Care Foundation

The China Primary Health Care Foundation (hereinafter referred to as CPHCF) is a non-profit, 4A-grade public fundraising foundation with independent legal person status. It is sponsored by the Central Committee of the Chinese Peasants and Workers Democratic Party and supervised by the National Health and Family Planning Commission, with the mission of funding and developing primary health care at the grassroots level, particularly in impoverished rural areas. Official website: http://www.cphcf.org.cn/zgcb/

# About Nuoyi^®

`NovoFine`^® (Novoeight^®), the generic name is Recombinant Human Coagulation Factor VIII for Injection, and the English name is Recombinant Human Coagulation Factor VIII for Injection (turoctocog alfa). This product is indicated for on-demand and prophylactic treatment of bleeding in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency). The strengths include 250 IU/vial, 500 IU/vial, 1000 IU/vial, and 2000 IU/vial.

NovoFine^®It is a third-generation B-domain-deleted recombinant factor VIII (rFVIII) that maintains procoagulant activity and utilizes a five-step purification process to reduce the risk of pathogen transmission. It safely and effectively prevents and treats bleeding in previously treated patients (PTPs) with severe hemophilia A, demonstrating a 0% inhibitor incidence rate in PTPs. The hemostatic treatment success rate is 95.4%, and the median annualized bleeding rate for patients receiving prophylaxis is 1.18 bleeds/patient/year.

# About Novo Nordisk

Founded in 1923, Novo Nordisk is a leading global biopharmaceutical company headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity, rare blood disorders, and endocrine disorders. To achieve this, we pioneer scientific breakthroughs, expand access to our medicines, and are committed to preventing and ultimately curing diseases. Novo Nordisk employs approximately 45,800 people across 80 countries and regions worldwide, providing products and services to more than 170 countries and regions globally. Novo Nordisk China Official Website: http://www.novonordisk.com.cn