Behind the explosion of Lianhua Qingwen, will the same name and prescription drug usher in development opportunities?

Since the fourth version of the new crown pneumonia diagnosis and treatment plan, Lianhua Qingwen capsules (granules) have been included in the list of recommended medications.

Every round of epidemic outbreak, even Huaqingwen capsules (granules) will appear "one medicine is difficult to find" situation.

Since April 2020, the new anti-new indication of Yiling Pharmaceutical Lianhua Qingwen capsules has been approved, and by the first half of 2022, a cumulative sales record of 4.256 billion yuan has been set.

The explosive Lianhua Qingwen, the rising power of traditional Chinese medicine, does it mean that the same name and prescription medicine will usher in development opportunities?

Traditional Chinese medicines "named" by the new crown

Since the outbreak of the new crown pneumonia epidemic, in the early absence of specific drugs and vaccines, Chinese medicine experts have summarized the rules and experience of traditional Chinese medicine in the treatment of viral infectious diseases, deeply explored ancient classic formulas, combined with clinical practice, and formed a diagnosis and treatment plan for the treatment of new crown pneumonia and a "Chinese plan" combining traditional Chinese medicine and Western medicine.

A variety of traditional Chinese medicine products have played an important role in the "war" against the epidemic without gunsmoke:

• For example, Jinhua Qinggan granules, Lianhua Qingwen capsules, Xuebijing injection and lung cleansing detoxification soup, wet septic formula, Xuanlung septic prescription and other "three medicines and three prescriptions" with obvious curative effects.

• As well as Huo Xiang Zhengqi capsules (pills, water, oral liquid), Pian Zixi (lozenge), Suhe Xiang Pill, Angong Niuhuang Pill, Xiyanping Injection, Shengfang Injection, Shengmai Injection, Heat Poisoning Ning Injection, Sputum Heat Clear Injection, Brain Awakening Injection, Sammai Injection, Qingkailing (granules, injection) and other famous and excellent varieties.

Most varieties, after obtaining the "title" of the treatment of the new crown, have basically achieved "volume and price increase".

Lianhua Qingwen capsules (granules) are even more "ridden in the dust" in sales.

Many companies are envious of the traditional Chinese medicines that have already obtained the "title"; There are also many enterprises in the capital winter, accelerating their entry into the field of traditional Chinese medicine, hoping to get a piece of the pie.

Representative anti-new crown traditional Chinese medicine

Caused by Lianhua Qingwei

The "same name and same prescription" opportunity

Similar to the "bombshell" of chemical drugs and biological drugs, everyone pays close attention to their patent expiration dates in order to start the road of imitation.

Many chemical generic drugs and biosimilars have also achieved good market returns:

• Among chemical generic drugs, such as sildenafil tablets, tadalafil tablets, rivaroxaban tablets, dapoxetine hydrochloride tablets, moxifloxacin hydrochloride eye drops, pipeociclib capsules, sodium hyaluronate eye drops, urapidil hydrochloride injection, oseltamivir phosphate dry suspension, apramilast tablets, etc. once surpassed the original research.

• Among biosimilars, bevacizumab, adalimumab, trastuzumab, rituximab, denosumab and infliximab bloomed.

In the context of the general downturn in the market, the explosive Lianhua Qingwen naturally attracted many attention. The rest of the new crown "special Chinese medicine" has also received more attention.

Is it possible that these Chinese medicine "bombshells" can also be copied and made into "the same name and prescription medicine"?

Imagine that the same name and prescription drug of Lianhua Qingwen capsules (granules), if it can share one-tenth of the market share of Ling Pharmaceutical, it will also have a sales scale of hundreds of millions of yuan.

In addition, traditional Chinese medicine has always enjoyed a special status in the process of centralized procurement, and has also become a haven in the wave of national centralized procurement.

The State Food and Drug Administration has successively issued policies such as "Registration Classification and Application Materials Requirements for Traditional Chinese Medicines" and "Technical Guidelines for the Research of Drugs with the Same Name and Prescription Drugs (Draft for Comments)", which means that the registration restrictions of the same name and prescription drugs have been relaxed, which has added another fire to this outlet:

• The state encourages the research and development of the same name and prescription drugs to be guided by clinical value, and the clinical value of the marketed traditional Chinese medicine with the same name should be fully evaluated, and the clinical value should be supported by sufficient evidence.

• At the same time, the use of new technologies and methods is encouraged to improve the quality of drugs and avoid low-level duplication.

In the future, unless there is patent protection and confidential formula in the development of traditional Chinese medicine, there is a risk of imitation.

Especially for "exclusive varieties", the market will focus on these hot "exclusive varieties", because the meaning of "exclusive" has been greatly weakened or canceled to a certain extent.

How do companies make the same name and prescription medicine?

Standing on the cusp, how can pharmaceutical companies grasp the policy opportunities of the same name and prescription drugs?

First, according to the "Technical Guidelines for the Research of the Same Name and Prescription Drugs", the most important thing is to select the right reference drug. The generic variety must have better clinical value than the marketed control drug, and how to find advantages in terms of effectiveness, safety, quality controllability and other aspects is something that enterprises must think about.

Second, the same name and prescription drug should do a good job in pharmacoeconomic evaluation, including which cycle of the control drug is worth following up? Whether it is the introduction period, the growth period, the mature period or the decline period, you must think clearly. Otherwise, the products that spend a lot of money to make will not get the desired commercial return in the end.

Third, the quality evaluation of imitation products should be fully considered. Who is the unit that sets the quality standards? Is it the first product to market, or is it the best-selling product on the market? For exclusive products, if their quality standards and processes are not included in the Chinese Pharmacopoeia, it is difficult for generic drug manufacturers to obtain their process standards and quality. This means that the first batch of generic Chinese medicines are likely to be exclusive products that sell well among the varieties included in the Chinese Pharmacopoeia.

Fourth, the authentic characteristics of Chinese medicinal materials. In view of the complex composition of the medicinal parts of traditional Chinese medicines, there are many factors affecting the consistency of the quality of traditional Chinese medicines, unlike chemical generic drugs, as long as the raw and auxiliary packages and processes are solved, generic drugs can basically be consistent with reference preparations. For the imitation of traditional Chinese medicines, it is necessary to consider that the source of the medicinal materials is consistent with the reference drug, that is, the species and origin of the medicinal materials must be consistent in order to reduce the deviation.

For some reference preparations that have mastered local medicinal material resources, it is possible to continue to maintain the existing price advantage in the future collective procurement by mastering both the cost and the raw materials. This also means that Chinese medicines containing some unique medicinal herbs are difficult to imitate.

Fifth, bioequivalence research is a difficult point, the most important thing is that the standards of reference preparations have not yet been determined, and bioequivalence research has no guidelines in Europe, the United States and Japan to refer to. Enterprises must fully study and judge.

In the future, is it possible that the drug with the same name and prescription will become another major window for traditional Chinese medicine? Let's wait and see.