Huizheng (Shanghai) Pharma Secures Exclusive Promotion Rights in China for Three Novartis COPD Maintenance Therapies

Huahai Pharmaceutical announced on the 16th that its board of directors had approved on the 15th the matter concerning its sub-subsidiary, Huizheng (Shanghai)Pharmaceuticals[Company Name] Technology Co., Ltd. (hereinafter referred to as “Huizheng”) has signed the Exclusive Promotion Service Agreement with Beijing Novartis Pharma Co., Ltd. (hereinafter referred to as “Novartis”) and Sandoz (China) Pharmaceutical Co., Ltd. (hereinafter referred to as “Sandoz”) for three drugs indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. Huizheng will obtain, on a paid basis, the exclusive promotion rights for these three drugs within the China region.

Pursuant to the Agreement, Huizheng shall pay Novartis a non-creditable, non-refundable signing fee in the amount of RMB 200,000,000 (two hundred million Renminbi).

The three drugs under this agreement are indicated for the maintenance treatment of adult patients with chronic obstructive pulmonary disease (COPD). As original innovative medicines developed by Novartis, they have all officially received import approval in China. They are:

(1) Indacaterol Maleate Inhalation Powder, trade name (Onbrez);

(2) Indacaterol/glycopyrronium bromide inhalation powder capsules, brand name (Ultibro);

(3) Glycopyrronium bromide inhalation powder capsules, brand name (Seebri).

All three aforementioned products are next-generation, originator inhaled medications. Clinical guidelines recommend LAMA/LABA combination therapies as a substitute for the currently prevalent hormone-containing combination regimens in the treatment of COPD. This therapeutic approach covers all patient groups requiring long-term management (GOLD Groups B–D), thereby establishing a comprehensive product portfolio for COPD treatment:

(1) Indacaterol maleate is the world’s first next-generation ultra-long-acting β2-agonist (LABA). Compared with existing products on the market, it offers advantages in efficacy, safety, and cost-effectiveness, and is recommended by international guidelines as a first-line treatment for Group B patients.

(2) Glycopyrronium bromide is the second long-acting muscarinic antagonist (LAMA) globally. Compared with the first-generation tiotropium bromide, it offers advantages in terms of onset of action, reduction in exacerbation rates, and improvement in quality of life. International guidelines recommend it as a first-line treatment for patients in groups B–C.

(3) The indacaterol/glycopyrronium fixed-dose combination is the world’s first newly launched long-acting beta2-agonist (LABA) plus long-acting muscarinic antagonist (LAMA) product. Its efficacy is significantly superior to existing products on the market, making it an alternative to inhaled corticosteroid-containing combination therapies for the treatment of COPD. It is currently recommended as a first-line treatment for Group D patients in international guidelines.

Chronic obstructive pulmonary disease (COPD) is a common chronic condition characterized by airflow obstruction, manifesting as chronic bronchitis and/or emphysema, which can progress to cor pulmonale and respiratory failure. The number of COPD patients aged 40 years and older in China is projected to increase from 69 million in 2016 to 100 million in 2027. Currently, the diagnosis rate remains low; however, with heightened health awareness and improved medical standards, the number of diagnosed cases is expected to rise from 16.9 million in 2016 to 36 million in 2027.

Current management of COPD should prioritize prevention and early intervention. For patients in the stable phase, a comprehensive treatment regimen including bronchodilators, glucocorticoids, and expectorants is required, with LAMA/LABA therapy occupying a central role in treatment.

According to IMS statistics, the Chinese market for anti-asthma and COPD drugs was valued at RMB 11.043 billion in 2017, with sales of long-acting bronchodilators (including corticosteroids) reaching RMB 5.8 billion. The market growth for asthma and COPD exceeds that of the overall pharmaceutical market and other chronic diseases. Currently, the mainstay of asthma and COPD treatment in China is the combination of LABA and ICS. Among LAMAs, only tiotropium is marketed in China. The market share of LABAs is relatively small.

Source: Sina Medical News

Compiled by Zhang Hongli