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Eddy Pharmaceutical (688488) Institutional Research and Investor Q&A Selection (202109)

Q&A:

First, please introduce the core technical advantages of Eddy Pharmaceutical's main product, human protein?

Since its inception, the company has been based on the field of human protein, the original "human protein online adsorption technology", on the basis of ensuring product activity, impurity control on the basis of developing a clean production process system for human protein products, overcome the environmental pollution, large-scale collection and purification of technical problems, break through the bottleneck of human protein raw material collection; by giving technical guidance to human protein raw material suppliers, establishing a long-term stable relationship with the first-line collection points, becoming the leading domestic can be large-scale downstream usstatin, The production base of eurecolin preparation manufacturers supplying crude products has built a double barrier between adsorption technology and resource channels.

The company has opened up the whole process of production process from crude products to APIs and preparations, and also has corresponding core technologies in the separation and purification of APIs and preparation processes. On the basis of mastering the core technology of human protein and consolidating its dominant position, the company actively extends the industrial chain of human protein, expands to downstream preparation varieties, carries out research on the development of relevant new indications, and builds a human protein product research and development pipeline around the field of anti-inflammatory and stroke. At present, human proteins in the pipeline include the research and development of new indications for usstatin preparations, the optimization of euremiclin preparations, and the research and development of a new class of drugs hemagglutinins. The company intends to become a leading human protein product development and production enterprise in China through the implementation of the integration of raw material preparations. With the advancement of R&D and commercialization process, the company's whole industry chain layout of human protein business will gradually take shape.

Second, your company's anti-AIDS drugs ACC007, ACC008 and the mainstream products in the market, Beitovy, Jiefukang, Suimeikai, Derenavir, Duckwave, Twick, Truvada, etc., is there an advantage in the efficacy of the product?

Aibond ® is the first oral domestic class 1 new drug in the field of anti-HIV, according to the results of phase III clinical research trials, as a representative drug of the third generation of non-nucleoside reverse transcriptase inhibitors, compared with the control group efaviren (the first generation of non-nucleoside reverse transcriptase inhibitors), Aibond ® has a unique product advantage, and it is expected to achieve a rapid upgrade of the domestic mainstream treatment plan after listing, and the specific advantages are as follows: First, excellent safety: Aibond ®Phase III clinical data show that Can significantly reduce drug side effects;

Second, excellent effectiveness: Ebond ® half-life is about 26 hours, only need to take the drug once a day, its inhibitory level is equivalent to the first-line drug efaviren, and it is effective for high and low viral load;

Third, there are few drug interactions: Aibond ® is metabolized by the CYP2C19 pathway, and clinically does not cause obvious drug interactions based on metabolic inhibition. Bitovir, Jiefukang, Suimeikai, Derenavir, Duckwave, Twick, Truvada are mostly products approved for marketing in recent years, and the effectiveness of drugs has been greatly improved, including Abond ® and ACC008, these products can achieve effective inhibition of the virus in terms of efficacy, and the difference of products is mainly reflected in the safety and convenience of taking. At present, the mainstream treatment schemes in the field of anti-HIV are all "cocktail" therapy with 2 backbone drugs and 1 core drug, and the backbone drugs are all nucleoside drugs, such as Dakwa and Truvada. Core drugs can be divided into first-line and second-line, first-line core drugs have non-nucleoside reverse transcriptase inhibitors and integrase inhibitors, and Abond ® is the first-line core drug. Derenavir is generally transliterated as darunavir is more common, the drug is a protease inhibitor, is a second-line core drug, while beetylvir, Jiefukang, Sumetkai and other drugs are integrase inhibitors as the core drug compound preparation.

ACC008 is based on Ebond ®, combined with lamivudine and tenofovir 2 nucleoside reverse transcriptase inhibitors developed in China's first three-in-one single-tablet compound innovative drug preparation, HIV patients only need to take 1 tablet a day, no need to take other anti-AIDS drugs, help reduce the burden of medication, increase compliance, reduce the occurrence of drug resistance. ACC008's combination regimen and drug selection are in line with international trends, and if approved for marketing, it will provide domestic patients with new options that are synchronized with the world.

3. How big is the future market for usstatin and euremiclin preparations?

According to the IMSHealth & Quintiles research report, under neutral conditions, the market size of usltadine preparations will be about 5 billion yuan by 2027, and surgical drugs and sepsis patients are the main boosters. At present, only Temp Biochemical exclusively produces and sells usstatin preparations in China, and the main indication is pancreatitis, so the product still has a large blank market to be developed, and the potential is huge. In the Indian market, overseas affiliates invested by Eddy Pharmaceuticals have brought usstatin preparations to market. In the first half of 2021, the intensification of the epidemic in India increased the demand for urastatin preparations in the local market. At the same time, with its safety and efficacy, usltadine preparations have gained a high degree of recognition in the Indian market.

Eurekelin is ideal for the full treatment of ischemic stroke, and is recommended in the guidelines to reach the same level as butanphthalide; compared with competitors, eurekelin has a clear mechanism of action and a longer time window for administration, so the future growth trend is more clear. As per capita disposable income increases and Medicare coverage expands, more and more patients will have the ability to pay for Eurekelin, which, according to the IMSHealth & Quintiles study, is about $2.8 billion by 2027 under a neutral scenario. Fourth, what will be the company's layout in the field of anti-virus in the future? Will it create a long-acting injection R&D pipeline? The company is committed to building a complete anti-HIV drug research and development pipeline to meet the differentiated drug needs of domestic and foreign markets, and deeply develops a new anti-AIDS drug pipeline around the core unilateral drug Albert ®, and the products currently under research include ACC008 and ACC018. ACC008 is based on Ebond ®, combined with lamivudine and tenofovir 2 nucleoside reverse transcriptase inhibitors of the three-in-one single-piece compound innovative drug preparation, at present, the new drug market application for HIV-1 patients has been accepted by the State Food and Drug Administration, the preparation of on-site verification of drug registration is advancing; the Phase III clinical research plan for HIV-1 treated patients has passed the ethical review of Beijing Ditan Hospital, and the relevant clinical trial work has been officially carried out ACC018 is a new compound preparation of the company's benchmarking international advanced products, based on Ebond ®, combined with lamivudine and propofol tenofovir, and is now actively carrying out preclinical pharmaceutical research. At the same time, for the treatment of different stages of the HIV virus life cycle, the company has also accelerated the research and development progress of the integrase inhibitor ACC017.

Long-acting treatment is an important direction for future anti-HIV treatment, and foreign leading companies such as Gilead and GSK are laying out the research and development of long-acting treatments. The development of long-acting treatments is challenging to overcome many technical difficulties. From the perspective of the popularity of Anti-HIV drugs in China, we believe that the development of a more efficient and safer oral compound preparation of 1 tablet per day at this stage is more in line with the market demand for domestic drugs and more in line with China's national conditions, and the company's current layout and research and development of ACC008, ACC018 and integrase inhibitor ACC017 are also based on this consideration. In the future, with the gradual maturity and enrichment of the company's anti-HIV drug pipeline, some drugs should have the potential to develop long-term treatment.

Attached: Event Information Form

Investor Relations Activity Category

√ target research □ analyst meetings □ media interviews □ performance briefings □ press conferences □ roadshows □ on-site visits □ others

Participating organization name

Jinshifuying (Beijing) Investment Co., Ltd., Golden Meadow Investment LLC

Time

September 2021

The name of the receptionist of the listed company

Wang Guangrong (Deputy General Manager, Secretary of the Board of Directors), Lin Menghan (Investment Director), Zhou Weixuan (Securities Representative)

List of attachments

not

date

October 1, 2021

(This article was completed by the Securities Times e company writing robot "Kuaishou Xiaoe".) )

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