南宫NG28

Service background

Allergic conjunctivitis is caused by hypersensitivity of the conjunctiva to allergens, mainly manifested as type I and type IV hypersensitivity reactions. At present, our country lacks large-sample epidemiological data. In the United States, 40% of people suffer from this disease, but only 10% seek medical treatment. In Japan, 15% to 20% of people have a history of allergic conjunctivitis. More than 90% of patients in the United States suffer from seasonal allergic conjunctivitis, while in China, perennial and seasonal allergic conjunctivitis account for 74%.

In addition, the market size of ophthalmic drugs in China has grown from $1.8 billion USD in 2015 to $2.6 billion USD in 2019, with a compound annual growth rate of 9.3%. The size of China's ophthalmic drug market is only a small fraction of that of the United States (about 18%), indicating that there is a huge gap in China's ophthalmic drug medical needs.

Technology transfer of olopatadine hydrochloride eye drops

1. Product overview

Generic name: olopatadine
Indications: allergic conjunctivitis
Dosage form: multiple doses 0.2% specification
Usage and dosage: once a day
Marketing status: Launched in China in 2022
Patent status: no patent restrictions
Registration category: new 4 categories

2. Therapeutic status and future trends

Antihistamine and mast cell stabilizer dual action drug: As the first choice of basic drugs, this type of drug can stabilize the mast cell membrane and antagonize histamine at the same time, and has a good control effect on both acute and intermittent inflammatory reactions, and is well tolerated.

Glucocorticoid drugs: Topical use on eyes can effectively inhibit immune cell activation and inflammatory mediator release, and are suitable for severe or recurrent allergic conjunctivitis, but the use time should not be too long, and attention should be paid to monitoring the risk of complications.

Immunosuppressants: Such as Cyclosporine A and Tacrolimus, topical use on eyes can inhibit a variety of inflammatory mediators, and are suitable for severe allergic conjunctivitis, especially for patients who are intolerant to glucocorticoids. There is a lack of long-term safety data in the clinic, and the condition needs to be closely observed and the medication should be adjusted when used.

3. The popularity and progress of R&D
11 companies have approved the 0.1% specification; 3 companies have been approved for the 0.2% specification; Production verification has been completed and the stability is 3 months.

Our advantages

Use once a day, more convenient than 0.1% Olopatadine eye drops; One of the best drugs for allergic conjunctivitis, the market is growing rapidly; Currently, only the original research is on the market, and the generic has not yet been approved for domestic listing;
Price floor

Service process