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| Take a heavy dose of medicine! Research and development of osteoporosis is imminent |
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| Author：中國銘鉉 企劃部 Release Time：2017-9-6 15:43:55 Number Browse：868 |
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On September 6, a reporter from the medical network learned that the first parathyroid hormone (1-34) in the country developed by united self was approved for listing. Trapeptide is a blockbuster drug in the treatment of osteoporosis, with global sales of $1.5 billion in 2016. As the first domestic product to be approved in 2017, the drug will be checked through the strict 722 clinical data and will provide a new option for patients with osteoporosis in China.
China has the largest number of osteoporosis people in the world, with data showing that the number of osteoporosis patients in China is 90 million, and the number is expected to rise to 150 million by 2025. However, contrary to the huge market potential, our country, whether patients, doctors or enterprises, is far from understanding the value of the treatment of osteoporosis.
1 - there is not enough emphasis on disease
The clinical needs are unmet and the drug availability needs to be solved
From the point of mechanism, in addition to calcium and vitamin D based drugs, such as clinical treatment of osteoporosis can be divided into two categories: one kind is inhibit bone absorption of drugs, mainly including double phosphate (theory of phosphonic acid sodium, the azole phosphonic acid, etc.), calcitonin, selective estrogen receptor modulators, RANKL inhibitors, etc.; The other is to promote bone formation drugs, mainly parathyroid hormone (1-34) segments.
The current domestic market of osteoporosis treatment almost dominated by inhibiting bone resorption drugs, according to the m Intranet "China city public hospital chemical medicine terminal monitoring analysis system" (HDM) data, 2015 samples of the key cities for the domestic hospital osteoporosis drugs market is only 2.306 billion yuan, double phosphonic acid salts with about 30% of the share.
The vast majority of patients have not been clear diagnosis, even has a definitive diagnosis of patients are not treated, because the elderly often suffer from a variety of diseases, such as: high blood pressure, coronary heart disease, diabetes, and osteoporosis in before fracture often is in a state of can be neglected or ignored, such as once the hip or lower limb fracture, lying down his can't activities, the original organs such as heart, brain, kidney, lung diseases will increase and function has fallen sharply, serious consequences.
This stems from a lack of awareness of osteoporosis, Chinese are often get to the hospital after osteoporotic fracture osteoporosis diagnosis, at this time there has been a massive loss, bone disease has progress to a more serious stage, inhibit bone absorption of drugs can play a limited role. Tongji hospital affiliated tongji university endocrine metabolic disease research director et al pointed out that "inhibit bone absorption of drugs use is the best time to bone started quickly lost as in patients aged 60 or so commonly, osteoclast relatively more active period; When the bone loss is serious, it is urgent to promote bone formation to improve bone mass and improve bone microstructure.
The tenet, peptide is approved by FDA first applied in postmenopausal osteoporosis to promote bone formation of drugs, clinical studies have shown that special palmer peptide through its effect on promoting bone formation, not only can increase bone density, can significantly improve bone quality, effectively reduce the risk of bone fractures.
The telipopeptide, which was developed by the pharmaceutical company eli lilly, entered the Chinese market in 2011 and is the only one in the domestic market to promote bone formation. However, the cost of treatment for the drug is more than 6000 yuan per month, and the treatment cycle is less than 3 months, and more than 24 months. Most patients have difficulty in paying high treatment costs. In addition, doctors do not have sufficient prescription experience for promoting bone formation drugs, and a considerable number of doctors have only remained in the theoretical stage of the understanding of bone formation drugs. The market performance of tripeptides in China is a far cry from global markets.
In addition, osteoporosis patients are more than 60 years old, often with high blood pressure, diabetes and other common chronic diseases. Doctors and patients are dwarfed by the importance of osteoporosis treatment.
Therefore, it is particularly important for osteoporosis patients to provide affordable stimulative bone formation drugs, and more enterprises are involved in promoting bone formation drug advocacy. Reporter queries to, in addition to the peptide by the state of joint research and development of self similar medicine forthcoming, CST longda, suzhou golden union, and other enterprises in the research of products is also in different clinical stages, including individual companies have completed Ⅲ phase of clinical trials. It can be predicted that, with these products coming to market in the future, the accessibility of the bone-forming drugs will be greatly satisfied at home.
2 - release of market potential
Competition is heating up and domestic companies need to be strong
Have analysis, points out that in the field of osteoporosis, domestic enterprises listed for some varieties of generic weakness for many years, not overlooked by most drug firms tumor, diabetes, infections, etc.
But in interviews, a number of domestic companies are actually eyeing the osteoporosis market, and the layout of the relevant product lines is stirring. "As China enters an aging society, the number of osteoporosis patients will continue to increase, and the market size of osteoporosis drugs will no doubt grow larger and larger." Joint self tenet palmer peptide marketing product manager Liu Ting said, facing the embarrassing situation of osteoporosis field is prevalence, diagnosis and treatment, there is a huge gap between doctors and patients have insufficient understanding of the situation. "But it is also important to see that in recent years doctors and patients have gradually increased their focus on the treatment of diseases, and the potential for osteoporosis has been gradually released."
In fact, specific to the field of medicine, osteoporosis treatment drugs have the trend cluster to declare, the former two phosphates, after yesterday, including Pakistan yesterday he more drugs, varieties have attracted dozens of the above declaration.
In the field of biological medicine, due to the relatively high technical threshold, the platform is large, and the enterprises participating in the competition are not as fierce as the drug. Take triptapeptide as an example, it belongs to the hormone drugs, the dosage is very low, the quality control is very difficult, since 2003, the total number of enterprises that began to declare has only about ten. On the other hand, since 2015, CFDA has become more and more rigorous in the clinical data verification, and there is a significant proportion of those who stay in the clinical stage or withdraw the declaration.
"Early domestic biotechnology is not very mature, the platform threshold is relatively high, but more and more capital stepped in, now many small companies r&d progress very fast and could be more competitive in the future." Some in the industry are prejudged.
In addition to the competition between capital and technology, potential patent disputes deserve attention. According to the reporter, lilly has applied for patent protection of the patent and indications for the drug in the domestic market. Joint self to lilly this two patents in the challenge actively, eventually lilly patent is invalid, joint self only indications at a relatively low cost to obtain patent licenses, the two sides reached a settlement.
3 - development direction
A new drug or a new drug?
From global osteoporosis in product research, has the new mechanism is a handful of new drugs, have been many research institutions had high hopes of the fate of the single Romosozumab resistance for now is facing an uncertain future. Romosozumab activity by inhibiting bone sclerosis proteins has a dual function of promoting bone formation, reduce bone resorption, but the latest announcement shows that the FDA has refused to approve the drug market, and requires amgen/optimal than providing the drug data from two studies late.
Some in the industry speculate that a 30 per cent increase in cardiovascular risk may be the main reason for Romosozumab's rejection. Coincidentally, last year, Merck also abandoned its osteoporosis drug, histoproteinase K inhibitor odanacb, due to a 28% increase in the risk of stroke in the clinical trial LOFT.
Et al professor said, "from the Angle of clinical doctors, the efficacy and safety of the drug is carefully weighing, especially osteoporosis disease of this kind of give priority to with the elderly, security is especially important, when choosing drugs to fully weigh the patients benefit and risk, to consider the convenience of delivery."
In general, oral administration is more convenient for drugs than injections. In theory, patient compliance should be better, but effectiveness is also playing an important role.
Professor et al to Allen phosphonic acid and sodium and tenet peptide drug representatives of the two mechanisms, for example contrast, points out that Allen phosphonic acid sodium belong to oral dosage forms, but clinical applications, the patients compliance is not so good as imagination. Due to the drug gastrointestinal adverse reactions, and mostly elderly patients with osteoporosis, digestive function is weak, so many patients will often fall into "break medicine - became seriously ill take medicine -" cycle. Zoledronic acid is injected but still belongs to inhibitory bone absorption. Although tenet, by contrast, Mr Peptide need subcutaneous injection once a day, but for the condition of brittle fracture has occurred serious patients, it need to improve the quality of bone mass and improve bone, obvious benefit to patients can accept high frequency injection drug delivery methods, which has good compliance.
Professor et al, however, at the same time, said a daily way of injected is still not enough convenient for the patients, on the premise of guaranteed results, she is looking forward to the dosing interval longer cycle or are easier to implement ways of drug delivery.
It is reported that lilly cooperated with Zosano to try to exploit the new transdermal transmission technology of the latter, the new product of the parathyroid hormone, zp-pth. Another parathyroid hormone receptor Abaloparatide selective activation agent approved by the enterprise the Radius is the 3 m patent micro transdermal drug delivery system technology development Abaloparatide transdermal drug delivery dosage form, is currently in clinical trials.
It is understood that united ssell is actively exploring the convenience of enhancing the use of medicine. In the future, we will follow up the follow-up of the research and development of foreign micropin dosage forms.
conclusion
Osteoporosis is extremely harmful, and it is still relatively low in the market due to the lack of attention of doctors and patients. But as China enters an aging society, the problem of osteoporosis can't be avoided, and doctors' attention to osteoporosis is becoming more and more important. In the future, as more companies and products join, the market for osteoporosis treatment is expected to be large.
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