The pattern of improved new drug application has changed!

With the intensified competition of generic drugs and the in-depth homogenization of innovative drug research and development, improved new drug projects have gradually received attentio.

The declaration is the least, and the "1+2" is combined

Declare the hottest, avoid swarming

As for the CRO team, Yueyang Pharmaceutical has developed 16 products on its sustained and controlled release platform, including sustained-release tablets (briracetam, vildagliptin, metformin (including 24h), compound acetaminophen, lacosamide, sacu batrix valsartan sodium, vildagliptin), controlled-release tablets (amlodipine besylate, felodipine, loxoprofen sodium), dual-release tablets (pirfenidone, ramelteon) and Multi-release tablets (apixaban, apremilast, ibuprofen, compound ibuprofen, tofacitinib citrate), but no products have been reported for production ye.

Hengrui has also developed 16 products, and the declared products involve many different dosage forms, including injections (HR17020, HR18034, HR19024, irinotecan hydrochloride liposome), tablets (abiraterone acetate (Ⅰ), HR091506), capsules Tablets (HR19042, HRG2010), sustained-release tablets (ivabradine hydrogen sulfate), sustained-release capsules (ticagrelor), patches (HR19003), inhalants (HRG2010), eye drops (SHR8028 eye drops) , Oral dissolving film (HR17020), gel (HR20005), nasal spray (HR19024.
It can be seen that long-acting injection is the main dosage form of Hengru.
Abiraterone acetate tablets (I), irinotecan hydrochloride liposome injection, dexmedetomidine hydrochloride nasal spray and tadalafil oral dissolving film have been reported for production, but no products have been approved ye.

Lipin Pharmaceutical, which not only undertakes CRO business but also has the attributes of a pharmaceutical company, mainly develops oral dissolving membranes (aripiprazole, tadalafil, donepezil hydrochloride) and buccal membranes (palonosetron hydrochloride, doxepin hydrochloride) ), currently only aripiprazole oral dissolving film is reported for productio.

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[Project consideration] The industry often complains, and the topic of the improved new drug discussion is often: long-acting injections cannot escape risperidone, paclitaxel, aripiprazole, et.
, sustained and controlled release preparations are inseparable from nifedipine, piperipipr Ketone Controlled Release Tablet.
Judging from the recent hot spots, the projects of atropine eye drops, short-acting anesthetics to long-acting, and paclitaxel injections (excluding allergic excipients) have been overheated, and new projects should be cautiou.

New compound preparations (category 3)

The heat is rising rapidly, and the policy is pending

Category 3 refers to new compound preparations containing known active ingredients with clear clinical advantage.

In the past three years, the proportion of Category 3 declarations in the overall declarations of improved new drugs has also increased, reaching 10% in the first seven months of 2022.

Hengrui is the company with the most applications in category 3, and has declared HR18042 tablets, HRG2005 inhalers, and Henggliflozin metformin sustained-release tablets (I) and (II.

Fixed-dose compound preparations for lowering blood pressure, lowering blood lipids, lowering hyperglycemia, and anti-platelet are research and development hotspot.
For example, metformin sustained-release tablets (I) and (II) mentioned above, Lepu's ticagrelor aspirin capsules, ezetimibe bupitavastatin calcium tablets, Xinlitai's allisartan medoxomil and amlodipine tablets, aliza Tanzyl indapamide sustained-release tablets, empagliflozin, sitagliptin, and metformin sustained-release tablets of Yueyang Pharmaceutical.

[Project consideration] The guiding principles for improved new drugs for fixed-dose compound preparations have not been published, and the clinical practice of related compound preparations still needs to be further improve.

New indications (category 4)

Once crowded, now colder

Category 4 refers to formulations containing a known active ingredient for a new indicatio.
In the past three years, the number of 4 applications in the proportion of improved new drugs has been declinin.
In the first seven months of 2022, the proportion will reach 35.
Category 4 is mainly for new indications, which are more related to the success rate of clinical trials, and have little correlation with the technological improvement of preparation.
This article does not carry out detailed analysi.

How to do improved new drugs? The main difficulty lies in: how to obtain medical insurance payment and clinical approval after research and development, and also face the competition of homogenization project.
It is expected that companies with strong accumulation of generic drug technology are more likely to make achievements in the field of improved new drug.