[Transfer] Battle of Ophthalmology Innovation Pharmaceuticals

[Transfer] Battle of Ophthalmology Innovation Pharmaceuticals

Source: Archimedes Biotech

There are consumer attributes, and there are hundreds of millions of applicable people. The ophthalmology track comes with diamond halo. The limitation of corneal shaping mirrors is expected to relax and the Internet hospital Atto may be limited, and they have all risen to hot spots in the pharmaceutical industry. Behind these hustle and bustle, a heavy innovation incident is happening in the field of ophthalmology.

On June 21, Ou Kangwei announced that the First-in-Class Innovation Eye Medicine OT-401 (fluorine easily vitreous implanted) was approved by the State Drug Administration, filling the gap in the field in the field of globe in the field of uveitis in China It is expected to become a large single product with an annual sales of more than 1.5 billion yuan.

OT-401 is also the first drug in the history of Chinese medicine to be approved for listing with real world data.

From capital driving to innovation -driven, Ou Kangwei has completed the thrilling jump. It is the company with the largest number of innovative eye medicines currently conducted in the III clinical trial in CDE registration. In 2021, R & D investment is 455 million yuan. The total investment is 1.77 times.

The war of innovative eye medicine faucet has not yet settled.

Oukang Vision Pipeline fully covered the main eye anterior and rear diseases

Eyes are one of the most complicated organs in structure, and the pathological mechanism is unclear. In the past, drugs were mostly used to relieve symptoms. With the advancement of basic research, ophthalmology has entered the era of innovative drugs, and its wide and urgent clinical needs are met. The number of domestic ophthalmic patients far exceeds the United States, reaching 1 billion, but the market size of ophthalmology is less than one -five in the United States. According to FROST & SULLIVAN, the domestic eye drug market size is $ 4.3 billion this year, and in 2030 to $ 16.9 billion, with a compound annual growth rate of 18.7%, which is enough to support the high growth of head companies.

Clinical needs of ophthalmology are concentrated in myopia (170 million adolescent children), dry eye (210 million), wetting older macular degeneration (more than 5 million), and chronic vesicitis (1.44 million).

Esmitis is a horrible disease. Symptoms are painful, jealous, light, floating objects in front of the eyes, and decreased vision. Each inflammation will cause irreversible damage to the tissue in the eyes. The blindness rate of not intervention in patients reaches 25.3%, and the average age of blindness is 34 years.

The chronic non -infectious uveitis that affects the germs of the eye has urgent demand for rigid therapy, but the domestic standard treatment plan has a long -term vacancy. OT-401 is approved by OT-401 to improve this dilemma, becoming the first and only sustainable stability to release fluoride in the eyes, which is used to treat chronic non-infectious uveitis FIRST-in-CLASS drugs. Low -dose eye administration, one injection can improve the vision for 3 years (continuously released drugs for 36 months).

Oukang Weiwan is also the first domestic company to be approved by new drugs based on real world data.

On December 21, 2020, OT-401 entered the first batch of pilot lists of drug clinical world data applications in Hainan Provincial Pharmaceutical Supervision Bureau. In March 2021, based on the results of the real world data, Ou Kang visited CDE to submit an NDA application and was officially accepted in April. In December 2021, CFDI completed the on -site inspection. On June 16, 2022, OT-401 was approved by the State Drug Administration for listing. Every link, efficient and fast.

In the real-world diagnosis and treatment environment in China, OT-401 fluorine easily can significantly reduce the recurrence rate of patients with vesselitis, significantly improve vision, and implant OT-401 fluoro-relaxed systemic systemic drugs, local hormones in the eye, decreased significantly, macular edema edema Obviously relieve. The entire follow -up period is good, and no serious adverse incidents have not occurred.

Compared with Docuel and Eljian's Retisrt and Ozurdex, the OT401 has the advantages of simpler implants, longer medicinal duration, and better treatment effects. Extra bio-product ARVN001 (Qu Annai Decel vein neat injection suspension) entered the domestic phase III clinical research. The indication was secondary macular edema of the uveitis, and there was no direct competitive relationship with OT-401. VVN461, which is used to treat non -infectious uveitis, is entering the domestic phase I clinical trial.

OT-401 is expected to maintain an exclusive advantage for a long time. According to Oriental Securities calculations, the sales of the United States benchmarking in the United States, OT401 is expected to bring 1.5 billion market sales after listing. According to the calculation of Xingzi Medicine, 1.44 million patients with chronic non-infectious uveitis in China in 2020, conservatively estimated peak penetration rates of 3%-5%, OT-401 market space is 2.6-4.3 billion yuan.

Three major diamond markets, who are the main owners in China? Ophthalmology Hospital has a giant El Eye Department, with a revenue of 15 billion yuan in 2021. There are 174 domestic hospitals and 118 outpatient department. Ophthalmology equipment takes Aibo Medical as a potential leader and has a growth direction as an overseas giant Elkon+Studa Surgery. Ophthalmology is still in the early days of green development.

Xingqi Eye medicine has just exceeded 1 billion yuan in 2021, and the volume is still small. The advantage is that the awareness of marketization is strong. The leading layout of cyclolar droplets and low concentrations of Atto eye drops. stamina. There are two subsequent improved new drugs. He Kemosh's suspension eye liquid (immune rejection reactions after corneal transplantation) and voltolemidazole eye fluid (fungal keratitis) are in the clinical research stage, and they are not heavy varieties. In the field of eye underground disease treatment drugs with a difficult research and development, the layout lags weak. Only two drugs SQ-21127 (the treatment of new blood vessel-related diseases) and SQ-129 (the treatment of macular edema of the bottom of the eye) are in the preclinical research stage. Oukang Vision Pipeline has expanded to 23 drugs assets to achieve full coverage of the main eye front and rear diseases. Seven drugs have entered Phase III clinical trials. It is currently the most innovative pharmaceutical company in domestic ophthalmology drugs entering the number of clinical trials in stage III, including 3 eye underlying drugs.

After OT-401, Oukang Vision also has a number of potential items.

Nearly myopia delay: Low-concentration Atropine OT-101 is an index of Oukang Vision's self-developed product, which is different from Xingqi Eye Medicine Competition. First, the phase III clinical trial of OT-101 has become the first III multi-center clinical trial (MRCT) in the world's first III centered clinical trial (MRCT), including low-concentration Atropine and its analogy. The second is OT-101 launched a real world research in Boao, Hainan last October. Third, OT-101 uses an exclusive design of an innovative and closed split device to solve the problem of stability of low-concentration Atropine solution, so as to ensure that it provides sufficiently effective Atropine during the product shelf life. Comfort, thereby improving the compliance of medication.

Dry eye: Class 1 new drug OT-202 is a new molecular entity independently developed by Oukang Vision. By inhibiting the new mechanism of SYK kinase activity, to achieve anti-inflammatory effects to treat dry eyes, it is one of the few new target innovations in China. medicine. Phase I clinical trials have completed the first subject to enter the group.

Mattoptopathy: Ou Kang Weiwan is the only company that has achieved full coverage of macular lesions with the largest potential of business potential. There are three drugs in research. The in-eye injection of VEGF drug OT-702 (Abercip Biomedy) is expected to complete all the subjects who complete the phase III clinical trial at the end of this year to treat the degeneration of moisture and elderly, and the top three clinical progress in China. In 2021, Abercip Original Pharmaceuticals' markets outside the United States reached 3.6 billion US dollars, and there was no domestic anti -VEGF ophthalmidic drug and biological similar drug in China. OT-703 (fluorine easily vitreous implanted) entered the domestic phase III clinical trial this month and used to treat diabetic macular edema (DME). It is the only cortic steroid internal implants approved by the FDA for 3 years to treat DME.

Ou Kangwei holds the bank's balance and cash of 1.785 billion yuan. With the listing of OT-401, the hematopoietic capacity has greatly increased, the Suzhou plant is completed, and the annual production capacity is up to 455 million doses. It is one of the most certain 18A companies in commercialization.

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