Mucopolysaccharidosis type II drug Hiresi® is put into commercial application

June 5, 2021, Hangzhou, Zhejiang)---"Because of Rui, hope to set sail" 2021 Hai Ruisi® (Idox Sulfatase β Injection) China Commercial Launch Conference will be held in Hangzhou, which means Beihai Kangcheng Pharmaceutical Co.
, Ltd.
(hereinafter referred to as "Beihai Kangcheng") has invested China's first and only Mucopolysaccharidosis Type II (hereinafter referred to as MPS II, also known as Hunter Syndrome) enzyme replacement therapy (ERT) drug in China Commercial application
.

June 5, 2021, Hangzhou, Zhejiang)---"Because of Rui, hope to set sail" 2021 Hai Ruisi® (Idox Sulfatase β Injection) China Commercial Launch Conference will be held in Hangzhou, which means Beihai Kangcheng Pharmaceutical Co.
, Ltd.
(hereinafter referred to as "Beihai Kangcheng") has invested China's first and only Mucopolysaccharidosis Type II (hereinafter referred to as MPS II, also known as Hunter Syndrome) enzyme replacement therapy (ERT) drug in China Commercial application
.

On the eve of the launch event, Hi-Res® was first applied to the clinic by Professor Chaochun Zou, Chief Physician of the Endocrinology Department of Children's Hospital Affiliated to Zhejiang University School of Medicine, and officially served MPSII patients on May 23
.

With the implementation of the first prescription, this commercial launch event brought together the China Rare Disease Alliance, clinical experts, policy experts, patient organizations, and public welfare foundations.

"We are very honored to witness the important milestones of HiRes® being put into clinical application under the guidance of the "Expert Consensus on the Clinical Diagnosis and Treatment of Mucopolysaccharidosis Type II" that has just been released
.

" Beihai Kangcheng Pharmaceutical Dr.

Guests at the 2021 HiRes® China Listing Conference witnessed important moments together

New network: Initiate a standardized diagnosis and treatment project to improve the ability to diagnose and treat rare diseases

MPS II is due to gene mutation deletion or lack of lysosomal enzyme Idose-2-sulfatase (IDS), which leads to the accumulation of glycosaminoglycans (GAGs) in the body, causing abnormalities in multiple organ systems
.

MPS has been included in the "First List of Rare Diseases" in the country, ranking No.

To better improve the level of diagnosis and treatment in the field of mucopolysaccharidosis diseases, Mr.
Li Linkang, executive director of the China Rare Diseases Alliance, shared his approach: "For rare diseases such as mucopolysaccharidosis, patients are faced with overall diagnosis and treatment capabilities.
shortage of challenges
.

to solve this problem, we recommend that the parties should promote the registration of mucopolysaccharide storage disease patients, which will help experts understand the status of epidemiology mucopolysaccharidosis our country, clinical treatment and health care, Help policy decision-making departments to formulate intervention strategies for high-risk groups, improve the diagnosis and treatment service system, improve the level of patient medical protection, and provide scientific basis for improving the availability of drugs

New standard: in-depth interpretation of MPS II diagnosis and treatment consensus, and establishment of clinical diagnosis and treatment standards

The "Expert Consensus on the Clinical Diagnosis and Treatment of Mucopolysaccharidosis Type II" edited by the Endocrinology, Genetics and Metabolism Group of the Pediatric Branch of the Chinese Medical Association will be officially published in the Chinese Journal of Pediatrics, Volume 59, Issue 6, June 2021 The release of this consensus has filled the gap in standardized diagnosis and treatment of this disease
.

At this meeting, Professor Luo Xiaoping, the vice chairman of the Pediatrics Branch of the Chinese Medical Association, gave an in-depth interpretation of the consensus: "The Chinese Medical Association took the lead in formulating this expert consensus, which is based on clinical practice and borrowed from foreign related treatments, combined with domestic and foreign treatments.
Evidence-based research on the diagnosis and treatment of MPSII has clearly explained the clinical manifestations, differential diagnosis, treatment and genetic counseling of
MPSII.

The organ system damage caused by MPSII is almost irreversible.

Professor Fu Junfen, Executive Deputy Dean of the Children’s Hospital of Zhejiang University School of Medicine, shared: “The establishment of clinical diagnosis and treatment standards will greatly promote the diagnosis and treatment of clinicians, which is also a good thing for the majority of young and middle-aged rare disease experts working in the front line.
News
.

Taking MPSII as an example, the formulation of diagnosis and treatment specifications will more condense the cooperation of multidisciplinary teams, and enhance the diagnosis and treatment confidence of the young and middle-aged expert team.

New payment: Explore a multi-party payment system for rare diseases to improve drug affordability

For high-value rare disease drugs, high prices are the main barriers preventing many patients with rare diseases from taking drugs
.

In recent years, the government has explored the payment of rare diseases in various places, but under the premise of government-led payment, the patient's personal commitment is still a huge burden, requiring the intervention of the society to achieve the ultimate drug availability

Professor Xie Junming, member of the National Health Commission's Expert Committee on Diagnosis, Treatment and Protection of Rare Diseases, and appointed chairman of the Rare Disease Branch of the Zhejiang Medical Association, commented: "Patients with rare diseases have long faced a dilemma of having money without medicine, and medicine without money
.

Zhejiang.
In 2019, it was the first to introduce a special protection fund policy for rare diseases, and three rare disease drugs have been included, which reflects the government’s determination to lead the solution of rare disease protection
.
With China’s continuous improvement of the rare disease social security system, high-value rare disease drugs will be available in the future.
, We should build a government-led, multi-party co-payment and multi-level drug protection system for non-profit organizations, commercial insurance, pharmaceutical companies, and patients
.
Take Hai Ruisi® as an example, the drug has been successfully protected by Suhuibao, Zhouhuibao, and Huhui Included in the city’s customized commercial medical insurance under the guidance or guidance of many governments, such as China Insurance and Huijiabao, and jointly with the innovative payment project of “Rui Qi Xinsheng Patient Welfare”, multiple guarantees will effectively alleviate the burden of medication on patients and allow more patients to use them.
Can afford medicine
.
"

Lu Yijun, general manager of Beihai Kangcheng Pharmaceutical Co.
, Ltd.
, China, said: "Patient-centricity is the cornerstone of Beihai Kangcheng's development.
Our future business development will be based on the realization of this goal
.
The listing of Hai Ruisi® will bring the majority of MPSII patients.
Looking forward to it, we also sincerely hope that we can help more patients to use drugs
.
Therefore, while we are paying attention to the establishment of local rare disease drug protection mechanisms, we have been actively exploring multi-dimensional payment methods
.
At present, we are participating Urban inclusive insurance and the launch of innovative payment projects are only preliminary attempts on the road of multi-party payment
.
While developing and creating new drugs, we will continue to develop more innovative payment methods to improve the accessibility and affordability of innovative drugs , To help more patients to use and afford these drugs
.
"

New service: launching the care service system for patients with rare diseases

In response to the special needs of patients with rare diseases in terms of treatment and disease management, the conference also introduced the “CANCare Care for Rare Disease Patients”, established by the China Primary Health Care Foundation in cooperation with the Beijing National Health Research Institute and supported by Beihai Kangcheng.
Service system"
.
The service system will build service modules in terms of patient education, upgraded diagnosis and treatment, medication services, disease management and multi-party support, and provide care services throughout the life cycle for patients with rare diseases
.
Under this system, the free intravenous injection service map project for MPSII patients will also be officially put into use in the near future.
The project will revolve around the life radius of MPSII patients and lay the injection service network to facilitate patients to book injection services online at any time.
It is helpful for patients to carry out continuous standardized treatment, and at the same time reduces the treatment burden of patients
.

Ms.
Zheng Yu, Director of Beijing Zhengyu Mucopolysaccharide Rare Disease Care Center, shared: “In the future, patients with MPSII will no longer need to go abroad to use drugs.
This is great news
for our patients .
For most mucopolysaccharides For patients with storage disease, drugs are the key factor in solving their disease problems, but in order to achieve long-term standardized treatment, there are still many service pain points that need to be resolved
.
We look forward to the public's attention to rare diseases like MPSII that need to be confronted for life Patients, I also hope that more companies can provide more comprehensive care services around the actual needs of patients, help them smoothly walk through the entire process of diagnosis, treatment, payment to long-term disease management, and expand the length and breadth of life
.
"

About Beihai Kangcheng Pharmaceutical Co.
, Ltd.

Beihai Kangcheng Pharmaceutical Co.
, Ltd.
is an innovative biopharmaceutical company dedicated to accelerating the development and commercialization of innovative therapies for rare diseases and rare tumors in China and around the world to fill unmet medical needs
.

Beihai Kangcheng and WuXi Biologics have established a global partnership to jointly develop and commercialize patented therapies for rare genetic diseases
.
As a leader in the field of rare diseases in China, Beihai Kangcheng and GC Pharma of South Korea have signed an exclusive license agreement for Hunterase (Hailei®), an enzyme replacement therapy for Hunter syndrome, in Greater China.
The drug is now on the market in 12 countries
.
Beihai Kangcheng and LogicBio Therapeutics have reached a strategic cooperation and licensing agreement to develop, manufacture and commercialize gene therapy candidates for the treatment of Fabry disease and Pompe disease
.
Beihai Kangcheng also signed a cooperation agreement with the Horae Gene Therapy Center of the University of Massachusetts Medical School to research and develop gene therapies for the treatment of rare genetic diseases
.