China's children's drug shortage is avoiding hundreds of billions of markets.
According to statistics, currently, there are only 60 kinds of children's drug formulations in more than 3500 pharmaceutical preparations in China, and 90% of them have no suitable children's dosage form. The lack of professional children's medicines, the doctor directly depending on the child's height, weight and other conditions, the adult medicine appropriate reduction directly to take children become a common phenomenon in many specialized children's hospital.
"As we commonly used drugs, only the beauty of age, cephalosporin g cuo is a professional children's medicine, the other is not, at the time of prescribing, parents may even ask us to open the expensive imported drugs, because domestic in pediatric medicine this piece are in short supply, research and development is far behind." Shanghai children's medical center surgeon Chen told reporters.
According to the recently Kang Zhi pharmaceutical (300086 SZ) disclosure of investor relations activities form, children in China medicine market in general belong to the state of "underserved", industry research data to predict the size of the market in 2015, our country children's drugs can reach 120.82 billion yuan.
On the other hand, doctors in many children's hospitals report that some of the professional children's medicines they used to be used are disappearing.
Lack of medicine, the market is promising, so why is the drug company unwilling to continue to produce children's medicine?
High cost and low yield.
"With the same type of medicine, children need to do more clinical trials, and every age group has to do it, so it's going to be much higher in this area than the generic drug." Dr. Chan told reporters.
The research and development of children's medicine is one of the most expensive, time-consuming and complicated areas in the research and development of all drugs. Even if the r&d is successful, it will be faced with market cultivation and promotion difficulties. For children of different ages, different dosage forms, specifications and tastes should be studied, which is costly and complicated. In addition, the special requirements of the children's medicine on taste and the way of taking the medicine increase the cost of the pharmaceutical enterprises.
The company has produced an effervescent tablet to treat a child's cold, but the drug is now hard to find in the market.
"Effervescent tablets are better than tablets, but the cost is much higher and the pricing is not dominant." He was an internal staff thank a gentleman to tell a reporter, because the children's medicine pricing principle is how much medicine effective component content as a benchmark, and children's medicine effective component content is far lower than the adult, the corresponding price will be lower than the adult medicine.
"In fact, the children's medicine in production equipment, quality control, technology, clinical validation is not less than the adult medicine, some aspects in even higher, but can't get compensation from the pricing." "Mr Xie added.
In this case, it is not difficult to understand that pharmaceutical companies choose to give up children's medicine.
"We the drug since 1999 is the national exclusive, but since a few years ago introduced new children's medicine national standards, our products becomes is not up to standard, is now closed." "Mr. Xie told reporters.
Mr Hsieh stated "substandard" refers to product packaging does not meet the new national standard, at present they are looking for compliance import packaging, the fastest is expected to half a year, the "old medicine" to return to the pharmacy.
The new strict rules and regulations that are not yet sound have become another major reason for drug companies' reluctance to touch children's medicines.
Exclusive right or solvable dilemma.
"As our enterprise production of a children's medicine, in the United States have legal protection, to meet a specific condition when the doctor can only we this kind of medicine, so our market in the United States can be guaranteed. But in China the drug is not protected. If only consider work, after more than 20 adult medicine dose adjustment can be used instead of our products, so if the doctor is not recommended, our medicine is of no advantage, we are now considering leaving China this part of the market." Bristol-myers, vice President of corporate affairs, li xin told reporters.
Specific situation described li xin is the FDA (us food drug administration) drug AD hoc "market monopoly" for children: due to the special pediatric dosage form drug with fewer sales, the FDA in the modernization act of 1997 and 2002 pediatric best drugs act increased the economic incentives. Especially in pediatric exclusive rights act in 1998 gave additional authorization, that simply by pharmaceutical companies listed special pediatric dosage form drug or provide pediatric dosage information, protracted can be patented six months of treatment, it is also known as "98 pediatric regulations".
"Because of the high risk, high cost and low returns, other factory is not willing to develop this kind of medicine or experiment, the research and development enterprise profit is secured, the enthusiasm of investment in children's medicine is also improved." Li xin added.
He described the situation got Shanghai pharma (601607. SH) some research and development of children's medicine experts agree, "as the FDA, it on children's drug dosage form has special provisions, than in the domestic market are more strict specification, this is medicine research and development enterprise incentive for children." One of the experts told reporters.