2019-01-29| China

Weekly Top 5 in China (0127-0202)

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PD-1 Immunotherapy and Targeted Small Molecule Combination Therapy Clinical Trial Approved

On January 16, 2019, Kananji Medicine Technology (Shanghai) Co., Ltd., a wholly-owned subsidiary of Betta Pharmaceuticals Co., Ltd., received the National Medical Products Administration (NMPA) approval of the clinical trial of the monoclonal antibody Toripalimab (JS001) and new dug Vorolanib (CM082) combination treatment of previously untreated localized or metastatic mucosal melanoma.

Mucosal melanoma is a malignant tumor originating from the mucosa. It is highly prevalent in Asian, accounting for 22.6% of all melanomas, and is the second largest subtype of melanoma in Asian population. For advanced mucosal melanoma that cannot be radically resected, treatment is more difficult. In recent years, some breakthroughs have been made in the treatment of advanced mucinous melanoma, especially in the fields of individualized targeted therapy, immunotherapy and combination therapy.

Vorolanib is a multi-target receptor tyrosine kinase (RTKs) inhibitor against VEGFR and PDGFR targets, which inhibits neovascularization and tumor growth and overcomes the high toxic side effects common to similar targeted drugs.

Toripalimab is a recombinant humanized anti-programmed death-1(PD-1) monoclonal antibody addressing various malignant tumors. Combing Vorolanib and Toripalimab may modulate tumor microenvironment and potentiate the efficacy of checkpoint inhibitors.

Shanghai Pharmaceuticals Class 1 New Drug SPH3127 Tablet Formally Enters Phase II Clinical Study

Shanghai Pharmaceuticals and Beifang Herbs Supplier have recently conducted Phase II clinical trials of SPH3127 tablets, an antihypertensive drug. Preclinical pharmacological and toxicological studies have shown that the drug is significantly superior to similar products in terms of efficacy, bioavailability and medication safety range. Clinical Phase I studies have shown that the drug is safe in healthy subjects. Subjects in Phase II clinical studies were patients with mild to moderate essential hypertension who were intended to explore clinically safe and effective doses in this group of subjects. The drug was developed by Shanghai Pharmaceuticals and Japan’s Mitsubishi Tanabe Pharma.

The company has submitted patent applications for SPH3127 to 14 countries and has obtained 22 authorizations. On October 2018, Shanghai Pharmaceuticals acquired the right to develop and sell the drug in countries including the United States. China’s blood pressure lowering drug market has great demand and broad prospects. According to IQVIA, the total sales amount of blood pressure lowering drugs prescribed by Chinese hospitals in 2017 was 22.7 billion RMB.

Shanghai Pharmaceuticals Holding Co., Ltd.(SSE stock code 601607 and HKEx stock code 02607) covers pharmaceutical R&D, manufacturing, distribution and retailing. The business revenues was RMB 120.8 billion in 2016.

Alibaba and Suning Acquire China’s Leading Health Management Company

On January 15, Suning announced that it would acquire all the shares of iKang Guobin Healthcare Group through multi-party investment, including Yunfeng IK, Taobao China Holdings, Treasure Cottage Limited and other investors.

IKang Guobin is China’s leading health management company providing medical examination and medical services. Relying on its health care service center, a network of cooperative hospitals covering major cities across the country, and a strong customer service system, iKang Guobin provides individuals and groups with personalized healthcare, medical care, family doctors, chronic disease management, and health insurance service. IKang Guobin is the first medical examination company to go public in the US.

According to estimates, the current health check market has a scale of more than 150 billion RMB, and is expected to reach 240 billion RMB in 2020, and the industry growth rate is higher than the entire medical service industry. Behind the rapidly growing market, a large amount of commercial capital has entered.

China’s Anticancer Drugs First Recognized by FDA as the Breakthrough Therapy

On January 15, BeiGene announced that the US Food and Drug Administration (FDA) granted Zanubrutinib (BGB-3111) for the treatment of adult mantle cell lymphoma (MCL) patients who had previously received at least one treatment. This is the first time anti-cancer therapy developed in China obtained the FDA’s breakthrough therapy. This recognition marks an important step in the process of China’s innovative medicines going global.

Zanubrutinib is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) under development and is currently undergoing a wide range of key clinical trials worldwide as a potential monotherapy and in combination with other therapies to treat various B cell malignancies.

The FDA’s breakthrough therapy is designed to accelerate the development and review of new drugs for the treatment of serious or life-threatening diseases, and its preliminary clinical trials have shown that one or more clinically meaningful endpoints are compared to existing therapies. According to FDA guidelines, new drugs under development will receive a range of preferential treatments if they are approved for breakthrough therapy, including FDA reviewers carefully guiding the design of effective drug development programs, and policy and review resources with senior management involvement, as well as the qualifications for rolling reviews and priority reviews.

Currently, the National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) is reviewing the new drug application (NDA) for Zanubrutinib for the treatment of Refractory/Relapsed (R/R) MCL and R/R lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), both of which were included in the priority review.

Yan Xiaojun, senior vice president of BeiGene and head of global pharmaceutical affairs said, “We are pleased to learn that the FDA has awarded Zanubrutinib a breakthrough therapy. One of the characteristics of Zanubrutinib is the high selectivity of BTK, which is designed to maximize BTK occupancy and minimize off-target effects. More than 1,300 patients have been treated with Zanubrutinib worldwide; we are also conducting extensive clinical studies on it, including seven phase 3 or critical clinical trials worldwide or in China.”

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics.

Lenalidomide, the Multiple Myeloma Drug Approved by Chinese Authorities

Lenalidomide is the first recommended drug for National Comprehensive Cancer Network (NCCN) Multiple Myeloma Guide 2018. It is also the first-line treatment, second-line treatment, and the relapsed/refractory drug for the diagnosis and treatment of multiple myeloma in China in 2017.

Recently, Jiangsu Chia-tai Tianqing Pharmaceuticals received the approval for lenalidomide capsule by National Medical Products Administration. This marks the official approval of the multiple myeloma drug. As a new generation of immunomodulator, lenalidomide has immunomodulatory, anti-angiogenic and anti-tumor functions, it is widely used in the treatment of multiple myeloma, lymphoma, myelodysplastic syndrome, acute myeloid leukemia and other diseases.

In multiple myeloma cells, lenalidomide and dexamethasone synergistically inhibit cell proliferation and lead to tumor cell apoptosis. Multiple myeloma is the second most common hematological malignancy in the world. The lenalidomide original drug was approved for entry into China in 2013 and was included in the national medical insurance catalogue in 2017. In 2017, lenalidomide ranked first in the world’s best-selling anti-tumor drugs, becoming the “gold standard” drug for the treatment of multiple myeloma in the world. However, due to the high price of drugs, the drug is currently not fully used in China.

At present, the incidence of multiple myeloma in China is about 1/100,000-2/100,000, which has surpassed acute leukemia and become the second most malignant tumor in the blood system. The disease is mostly caused by middle-aged and elderly people, and the onset is concealed. Most patients are diagnosed at an advanced stage. As China’s population ages and the disease diagnosis technology is gradually improved, the number of patients will further increase.

Chia-tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ) (HKEx:02607) is the top 30 pharmaceutical company in China, a subsidiary of Sino Biopharmaceutical Ltd.



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