Chinese pharmaceutical preparation technology challenges international patents – major breakthrough achieved by Baheal Pharmaceutical
Qingdao Baheal Pharmaceutical Ltd. recently announced that, its advanced generics preparation technology has achieved major breakthrough, and Nida, an osmotic-controlled metformin-based diabetes medicine has been approved by FDA to come into the market, which will bring benefits to patients with type-2 diabetes, particularly, those patients accompanied with obesity and hyperinsulinemia.
It is reported that, the first batch of Nida will soon be delivered to the United States market, and hopefully approved for the Chinese market within this year. It’s promising to become the first osmotic-controlled extended-release tablet containing metformin in China.
Upon release of this medicine, patients shall take medicine once a day only to maintain stable blood glucose, and yield the same curative effect of foreign original drugs at 1% of its price. It means that, Baheal Pharmaceutical has reached the internationally advanced level in the R&D, production and quality system of advanced solid extended- and controlled-release preparations, and entered the international advanced level of preparations.
Good news for hundreds of millions of patients with diabetes with price as 1% of original drugs
With the development of global economy and improvement of residents’ living standards, in recent years, the morbidity of diabetes has kept rising, and turned out to be a major issue threatening the health of global people. According to the latest data from International Diabetes Federation, in 2017, about 425 million people were living with diabetes worldwide, which will reach 629 million by 2045 with the continuous increase in the future.
Therein China, the country with most diabetes patients, is the home to one fourth diabetes patients worldwide, up to 114 million. In the meantime, the medical expenditure assumed by China for treating diabetes and its complication ranks to be the second on a global scale, and causes greater burden to individuals and social economy. In 2017, the total expenditure was RMB385.00 billion.
As proved by multiple authoritative institutions worldwide, metformin HCL serves as the preferred drug and first-line drug for the treatment of type-2 diabetes. Due to diversified factors like domestic preparation level, the dosage form selected by Chinese diabetes patients is substantially different from that by American diabetes patients. The American market is dominated by extended- and controlled-release dosage forms with market share up to 94%; in China, common immediate-release dosage form enjoys predominance, and the proportion of extended- and controlled-release dosage forms only around 22% with osmotic-controlled extended-release tablet containing metformin absent. The reason lies in that, very few Chinese pharmaceutical companies have grasped the controlled-release technology with high barriers, and advanced generics enjoying identical quality and curative effect with original drugs far less.
Nida, a bran-new hypoglycemic product with osmotic pump controlled-release technology adopted, has had abbreviated new drug applications to the US authorities, and distinguished itself from commonly used metformin-based products in China.
By report, metformin HCL (Nida) developed by Baheal Pharmaceutical applies the advanced and unique osmotic pump controlled-release technology, and thus guarantees the uniform release thereof in vivo, which makes blood concentration more stable, relieves gastrointestinal stimulation, toxic and side effect, reduces administration frequency of diabetes patients, and enhances the compliance of patients, a good news for quite a few type-2 diabetes patients.
?Compared with original drugs, Nida stays the same in terms of active ingredients, administration route, dosage form and dose, use condition and bioequivalence, and completely satisfies the provisions issued by FDA. It’s worth mentioning that, the future market price in China is possible only 1% of original drugs in the United States market.
The technical barrier of “osmotic pump” was conquered by Baheal Pharmaceutical for ten-year research and development with great concentration
To our knowledge, the oral dosage subject to osmotic pump controlled-release technology suffers given technical barriers, and sets higher requirements for preparation technology, preparation equipment, quality control and operators. In the industrialized mass production, particularly, it’s difficult in maintaining the within-run and between-run homogeneity. For worse, the production cost is also higher. In the past, this preparation technology was mastered by a very few pharmaceutical companies.
Osmotic pump preparation technology mainly includes single-chamber, double-chamber and multi-chamber osmotic pump, while Nida adopts the single-chamber osmotic pump technology with laser boring on both sides. Different from common tablets or matrix sustained-release tablets containing metformin, the once daily oral dose for patients is pressed into the tablet core wrapped with controlled-release coating membrance, with two drug release holes drilled by laser on both sides. As a result, relatively constant drug release dose in unit time can be achieved with a view of maintaining constant blood concentration, yielding longer duration of pesticide effect, simultaneously relieving the stimulation of gastrointestinal tracts, and reducing the administration frequency. In this regard, the administration frequency will decline from 3-2 times per day to once a day.
Thanks to the 10-year innovative research and development, Baheal Pharmaceutical eventually mastered osmotic pump technology, an advanced solid preparation technology, and had its 5 extended- and controled-release projects winning the support from National Major Scientific and Technological Project for “Significant New Drug Development” in the 13th Five-Year Plan period. Designed by NNE, a globally famous pharmaceutical design company, Baheal Pharmaceutical concentrates on the R&D, productions and sales of osmotic pump, pallet thin film coating and matrix sustained- and controlled-release preparations and other advanced solid preparation technologies, and has established a set of perfect R&D and quality management system. On the initial FDA identification, its factory passed verification with zero defect, which laid a solid foundation for the approval of Nida by FDA.
While submitting the ANDA (Abbreviated New Drug Application) to FDA for Nida, a metformin hydrochloride extended-release tablet, Baheal Pharmaceutical also confronted the patent challenge because manufacturers of original drugs had conducted special patent protection for their drugs, including administration method of “once a day” and time to peak of blood concentration. Upon 2-year patent litigation, Baheal Pharmaceutical finally broke through as a result of its exclusive and innovative osmotic pump controlled-release technology.
The dominant pattern of foreign enterprises may be altered, and Baheal Pharmaceutical has reached the innovation frontier.
So far, foreign enterprises always dominate the Chinese diabetes market. According to data disclosed at MENET.COM.CN, among the top ten enterprises rated as per the sales volume of chemicals and diabetes medication to public hospitals in key cities, there are 9 foreign pharmaceutical companies. With regard to the sales of melbine, the leading share is also occupied by foreign enterprises.
As the state has conducted evaluation of domestic generics in terms of quality and curative effect consistency, an increasing number of Chinese pharmaceutical companies has laid great stress on the improvement of R&D ability, process capability and quality management ability, and Chinese advanced preparation technology is promising to take on outburst in the coming years. With the approval of more drugs manufactured by domestic enterprises upon mastering high technology and conquering high barriers, the replacement of original extended- and controlled-release preparation products is imperative.
After Nida developed by Baheal Pharmaceutical delivered to the United States market, the pattern that the diabetes market is monopolized by internationally giant pharmaceutical companies may be changed. According to Lei Jifeng, company board member of the Company and once being Chairman of ISPE China, “as Chinese authorities encourage excellent generics pharmaceutical companies in China to participate in international competition, we will make active efforts to become the R&D and manufacturing platform of internationally advanced generics, to develop more advanced generics featuring identical quality and curative effect with original drugs, to facilitate the replacement of such original drugs as with expired domestic patent, and to deliver extended- and controlled-release preparations with identical curative effect yet proper price to domestic and foreign patients.”
Incubation of ecosphere: Baheal Pharmaceutical Group has incubated an international platform of advanced generics
Currently, the largest problem Chinese generics confront is the difference between generics and original drugs in quality and curative effect. Besides, drugs subject to large-scale industrial production shall have the consistency of curative effect further improved. To pursue the internationally advanced level, mature advanced generics pharmaceutical companies shall combine diversified factors like talents, technology, equipment and process, take technology and quality as driving force, and orient at the direction of technology and talents.
Under the guidance of national policies, Chinese generics pharmaceutical companies have quickened their pace of reform, while Baheal Pharmaceutical aims at facilitating and driving the internationalization of Chinese pharmaceutical preparation technology. Baheal Pharmaceutical shall have the R&D and production level of Chinese preparations keeping pace with the international one, endeavor to become the pioneer of advanced generics, realize the sales of same drugs in China and America as well as the collinear production, and empower Chinese people to have access to drugs with the same curative effect and quality of original drugs at a proper price, according to Lei Jifeng.
Baheal Pharmaceutical is an innovative enterprise incubated by Baheal Pharmaceutical Group within its financial service ecosphere. As a platform-based enterprise, Baheal Pharmaceutical Group shall promote the growth of innovative enterprises as an industry investor, and based on its profound industry experience, render vigorous support to invested enterprises in terms of domestic and foreign industry resources, capital, brand, marketing and management, so as to make innovative enterprises yield development and expansion in the ecosphere of Baheal. The successful incubation of Baheal Pharmaceutical may be attributed to correct direction, top-notch talents, advanced mechanism and sufficient resources.