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1. For the indication of allergic asthma, if FB825 passes Phase II and III human trials and obtains the drug permit license in the future, will this drug permit license and sales rights belong to Oneness Biotech or LEO Pharma?
2. The Phase II trials of FB825 allergic asthma were all enrolled in Taiwan, while the trials of FB825 AD were mostly enrolled in the United States. Does that mean AD is mainly licensed in the United States and this drug of allergic asthma is mainly sold in Asia and China?
1. Microbio (Shanghai) is responsible for the Phase IIa clinical trial of FB825 allergic asthma, and the subsequent clinical trials, development of new indications and acquisition of drug permit license, etc., are the responsibilities of our partners. Drug permit license and sales rights also belong to the partners, but they need to pay the milestone payment and royalty according to the contract.
2. Both of them will focus on the global market, but were tested in different regions. Even if Phase II is completed in Taiwan, Phase IIb or Phase III trials can still be continued in the United States as long as they comply with the regulations.
Newspapers reported that the research team of Genomic Research Center, Academia Sinica purified and separated the antibodies generated by transgenetic mice vaccinated for 2 doses of monoglycosylated vaccine, found a super antibody, called “m31A7”, with higher affinity than all the monoclonal antibodies on the market, and known from the structure of the super antibody that it can pass all currently known virus mutation variation loci, with stronger binding force with SARS-CoV-2 RBD, which is more than one hundred times better than the current common single strain antibody. If it is put into the clinical treatment in the future, it will be a powerful tool for the treatment of patients.
1. If the m31A7 super antibody is successfully developed and marketed in the future, will it be competitive with SNS812?
2. Does Oneness Biotech intend to seek the authorization for clinical trials from Genomic Research Center?
1. Foreign literature has proved that 80% of the novel coronavirus virus mutations occur in the spike protein of the virus. Antibody is a drug that neutralizes the spike protein. Therefore, even if an antibody that can neutralize the current key mutant strains is found through artificial screening, as long as it is an antibody, it will encounter the challenge of high variation of spike protein. SNS812 selected the gene regions that were not mutated from SARS to SARS-COV2 and had a relatively low chance of being affected by viral mutations.
2. The development of new antibody drugs takes a long time and there is no such authorization plan now.
Here are some of my questions regarding the “nucleic acid-based drug for coronavirus” under the cooperation of your company and Microbio (Shanghai) Co., Ltd.:
1. Which target does the “nucleic acid-based drug for coronavirus” meets, “Best in class”, “First in class”, or “Unmet medical need”?
2. Is the “nucleic acid-based drug for coronavirus” referring to SNS812?
3. Cytotoxicity test, acute toxicity test, and animal testing have been conducted for the “nucleic acid-based drugs for coronavirus” in January. What is the progress so far?
4. What is the marketability of the “nucleic acid-based drug for coronavirus”? Will it still maintain its value after the pandemic is over?
1. SNS812 is the first in class nucleic acid-based drug for coronavirus. It is developed to meet the unmet medical needs for the treatment against coronavirus.
3. During the first animal challenge study completed in February this year, it was observed that SNS812 has successfully improved the symptoms of the infected mice. In the past two months, the R&D team has conducted a variety of modifications and formulation tests to help the delivery of drugs in the body and improve the efficiency of drug absorption. The animal challenge study is scheduled to be conducted again in May. If there is experiment data sufficient enough to support the entry of human subject research, preparations for the entry of the drug into Investigational New Drug (IND) will be officially launched.
4. Clinical studies have shown that the variability of coronavirus will ultimately lead to the development of flu. In the future, coronavirus drugs may resemble Tamiflu® with long-term and seasonal demand. At the same time, virus strains resistant to multiple vaccines have emerged one after another. The B1.617 variant, which accounts for 60% of the total number of infections in India, is a vaccine-resistant virus strain. Since the mechanism of SNS812 is different from vaccines, the virus is not easy to develop resistance to this drug, which is also the value of SNS812.
Will Fespixon be sold by the company or sold by Microbio on behalf of the company in the market of Taiwan? Or will it be licensed in accordance with the original plan?
1. Since there is little incentive for the international pharmaceutical company to access the market in Taiwan, the value of “Fespixon” is not only in the drug permit license acquired in Taiwan but also the value generated thereafter, which include (1) New DFU drugs that went through rigorous scientific tests and met relevant laws and regulations (with new drug review in Taiwan meeting international standards); (2) International markets where Taiwan CPP can be launched for sale (3) Continuous extension of international marketing test; and (4) Exclusivity of the new drug “Fespixon” in the global market.
2. At present, Oneness Biotech has activated: (1) priority plan for launching new drug globally; (2) Phase III clinical trial, Fast Track Designation, and the quick access to the US market, an advanced country with the largest market demand for DFU treatment; (3) Simultaneously applying to the advanced countries for the new formulation of medical devices and diversified marketing channels; (4) Initiating several clinical trials in cooperation with the clinical physicians to expand indications and submit papers to the international journals.
3. Since negotiation relies heavily on the strength of the negotiators, Oneness Biotech couldn’t randomly sign licensing agreements with any international pharmaceutical companies with the use of drug permit licenses acquired in Taiwan alone (just because we wouldn’t, doesn’t mean we couldn’t). Oneness Biotech is also fully capable of selling new “Fespixon” drugs in Taiwan, even better than the Taiwan branch of an international pharmaceutical company (it doesn’t necessarily sell by ourselves). What Oneness Biotech should do right now is to accelerate the development of our strength, increase the global value of “Fespixon”, and then negotiating over international licensing.
4. In order to protect the shareholder’s equity of Oneness Biotech, we will not disclose any matters related to the negotiation of licensing, neither will we respond to similar questions about licensing in the future.
Greetings to Oneness Biotech! I am a shareholder and a layman of biotechnology. Here are some of my questions about the international licensing fee (not specifically to Oneness Biotech):
1.What are the main considerations for international pharma companies to negotiate the amount of licensing fee?
2.Assuming that the licensing party manufactures the drugs on its own, will it affect the amount of the licensing fee?
1.The main considerations include international competition, the action of mechanism, the term of patent, and the market size of the licensee, of which the market size of the licensee has the greatest impact.
2.If the drug is manufactured by the licensing party, it will generate manufacturing benefits for the licensing party but will have little effect on the amount of licensing fee.