BIOCURE TECHNOLOGY INC.

Administration’s Dialogue & Evaluation

As at September 30, 2021

INTRODUCTION

The next administration’s dialogue and evaluation (“MD&A”) is a evaluate of operations, present monetary place and outlook for the Firm and is carried out by administration utilizing the knowledge obtainable as at November 29, 2021. Now we have ready this MD&A close to Nationwide Instrument 51-102F1 of the Canadian Securities Directors. This MD&A needs to be learn together with the Firm’s audited consolidated monetary statements for the yr ended December 31, 2020 (“Annual Monetary Statements”) and the unaudited consolidated monetary statements for the 9 months ended September 30, 2021 and the associated notes thereto. The Firm’s Annual Monetary Statements are ready in accordance with Worldwide Monetary Reporting Requirements (“IFRS”). All quantities are expressed in Canadian {dollars} until in any other case indicated. The data contained herein isn’t an alternative choice to detailed investigation or evaluation on any explicit problem. The data supplied on this doc isn’t meant to be a complete evaluate of all issues and developments in regards to the Firm.

As used on this MD&A and until in any other case indicated, the phrases “we”, “us”, “our”, “Firm”, and “CURE” confer with Biocure Expertise Inc. Until in any other case specified, all greenback quantities are expressed in Canadian {dollars}. This MD&A incorporates sure data forward-looking statements. Ahead-looking statements might also be made within the Firm’s different reviews filed with or furnished to the Canadian securities commissions. Ahead-looking statements are topic to dangers and uncertainties that might trigger precise outcomes to vary materially from such statements. The phrases “goal,” “anticipate,” “imagine,” “proceed,” “might,” “count on,” “intend,” “possible”, “might,” “optimistic,” “plan,” “potential”, “predict”, “ought to,” “would,” and different comparable expressions are meant to establish forward-looking statements. These statements are usually not ensures of future efficiency, and subsequently you shouldn’t put undue reliance upon them. The fabric assumptions supporting these forward-looking statements embrace, amongst different issues the Firm’s means to:

  • receive any needed financing on acceptable phrases;
  • preserve tempo with fast modifications in shopper calls for;
  • depend on third get together producers;
  • handle enlargement successfully;
  • implement its mental property rights;
  • launch extra product strains;
  • retain its expert personnel;
  • handle present tax and regulatory regimes;
  • handle the fluctuation in international forex change charges and rates of interest; and
  • comply with basic financial and monetary market situations.

A few of the components that will trigger precise outcomes to vary materially from these indicated in these statements are discovered within the part “Danger Elements” on this MD&A.

The forward-looking statements contained on this MD&A replicate our views and assumptions solely as of the date of this MD&A. The Firm undertakes no obligation to replace or revise any forward-looking statements after the date on which the assertion is made, besides as required by relevant legal guidelines, together with the securities legal guidelines of Canada.

OUR BUSINESS

Biocure Expertise Inc. (the “Firm”) was included beneath the Enterprise Company Act (British Columbia) on August 24, 2007. The Firm is engaged in a mineral exploration property challenge by a restricted partnership. The Firm can be engaged in growing and commercializing a number of biopharmaceutical applied sciences regarding makes use of of recombinant and ranibizumab. The Firm’s head workplace is situated at Suite 300, 1055 West Hastings Avenue, Vancouver, BC, Canada.

On November 24, 2017, the Firm acquired 100% of the issued and excellent widespread and most popular shares of BiocurePharm Company (“BP Korea”), in change for the widespread shares of the Firm (the “Transaction”).

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BiocurePharm Company (the “Firm” or “Biocure”), a personal company, was included on August 29, 2005 beneath the legal guidelines of the Republic of Korea. The Firm was established to develop and commercialize a number of Biosimilars and biopharmaceutical applied sciences for manufacturing of biopharmaceuticals in Korea and oversea international locations. The Firm’s registered and head workplace is situated at S-202, Pai Chai College Daedeok Campus, 11-3 Techno 1- ro, Yuseong-gu, Daejeon, Republic of Korea.

Established in 2005, Biocure is a biopharmaceutical firm centered on growing biosimilars based mostly on Recombinant Protein Expertise, Cell Tradition Expertise, Protein Purification Expertise, and Bio-processing Expertise. Biosimilar is outlined in Wikipedia as follows: “A biosimilar (often known as follow-on biologic or subsequent entry biologic) is a biologic medical product which is nearly an an identical copy of an authentic product that’s manufactured by a distinct firm. Biosimilars are formally accredited variations of authentic “innovator” merchandise and will be manufactured when the unique patent expires.”

Biocure has developed expertise to provide three biosimilars reminiscent of Interferon-β, Ranibizumab and Filgrastim. Biocure is totally able to proceed with preclinical and scientific checks for these three merchandise each time funds can be found.

Even after the scientific check is finished and merchandise are accredited, one of many greatest difficulties and dangers to a biopharmaceutical firm is gaining a business manufacturing facility. Presently, the Firm has entry to a third-party Good Manufacturing Follow facility (“GMP facility”) in Korea to attenuate upfront capital necessities in addition to funding dangers for the commercialization of its merchandise.

Korean authorities believes the biopharmaceutical trade will drive the nation’s development for the subsequent era. As a part of its initiatives, Korean authorities and Daejeon municipality authorities have invested 25 billion South Korean Wons (“KRW”) in complete, 12 billion for the Fermentation & Purification course of and 13 billion for the Fill & End course of, to construct a GMP facility in 2011 to assist venturous biopharmaceutical firms, who lack funds to materialize business productions. The GMP facility is provided with full strains of the Fermentation & Purification course of and the Fill & End Packaging course of.

The GMP facility has ample capability to commercially manufacture and bundle biopharmaceuticals based mostly on recombinant micro organism, Interferon-β, Ranibizumab, Filgrastim, and Recombinant development issue. For instance, Biocure might produce Interferon-β at this facility by 4.8 million vials per yr. The world consumption of Interferon-β is estimated about 20 million vials a yr, so the manufacturing from this facility might cowl about 24% of world consumption.

Biocure has a proper to make use of this GMP facility at any time on a long-term lease or on a payment foundation. For the reason that GMP facility is a state-runnon-profit group, the phrases and situations are very beneficial to Biocure.

The dangers to provide and market biosimilars are time and value till preclinical check, scientific check, product approval and registration course of are full. With a view to mitigate these dangers, Biocure is in dialogue with events within the international locations, who’re in critical want for biosimilars that Biocure has expertise to provide. These international locations have many sufferers affected by illnesses that may very well be handled by Biocure’s merchandise, however authentic merchandise from multinational pharmaceutical corporations are too costly for these sufferers to entry as a result of excessive pricing coverage with a patent. Biosimilars might resolve such issues and be obtainable at far more reasonably priced costs.

Biocure is providing one-stop answer to these international locations, i.e. Collaboration on the implementation of preclinical and scientific check, expertise switch to provide biosimilar, GMP facility design & manufacturing tools choice, total high quality management course of for the ultimate merchandise and so forth. By this scheme, Biocure might mitigate dangers considerably to enter into new markets with its biosimilar expertise. Working with native companions in these international locations might considerably cut back monetary and advertising dangers. As well as, Biocure ought to be capable to get a expertise switch payment in addition to a license payment or royalty from the companions upon business manufacturing

Biocure doesn’t have a constructive money move and deal with the scientific trial for CAR T Cell Remedy in Korea to expedite the primary commercialization of its merchandise.

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PRODUCT PORTFOLIO

1. Interferons- β

Interferons (“IFNs”) are a bunch of signaling proteins made and launched by host cells in response to the presence of a number of pathogens, reminiscent of viruses, micro organism, parasites, and likewise tumor cells. In a typical situation, a virus-infected cell will launch interferons inflicting close by cells to intensify their anti-viral defenses. IFNs belong to the big class of proteins referred to as cytokines, molecules used for communication between cells to set off the protecting defenses of the immune system that assist eradicate pathogens. Interferons are named for his or her means to “intrude” with viral replication by defending cells from virus infections. IFNs even have varied different features: activate immune cells, reminiscent of pure killer cells and macrophages; improve host defenses by up-regulatingantigen presentation by advantage of accelerating the expression of main histocompatibility complicated (MHC) antigens. Sure signs of infections, reminiscent of fever, muscle ache and “flu-like signs”, are additionally brought on by the manufacturing of IFNs and different cytokines. Greater than twenty distinct IFN genes and proteins have been recognized in animals, together with people. They’re sometimes divided amongst three lessons: Kind I IFN, Kind II IFN, and Kind III IFN. IFNs belonging to all three lessons are necessary for preventing viral infections and for the regulation of the immune system.

The IFN-β proteins are produced in recombinant micro organism and animal cell. They’ve antiviral exercise that’s concerned primarily in innate immune response. Two sorts of IFN-β have been described, IFN-β1(IFNB1) and IFN-β3(IFNB3). IFN-β1 is used as a remedy for a number of sclerosis because it reduces the relapse fee. IFN-β1 isn’t an acceptable remedy for sufferers with progressive, non-relapsing types of a number of sclerosis.

The originator of Interferon beta was Schering AG (Berlex in North America), now part of Bayer HealthCare, and the patent expired in 2010. Presently, EMD Serono Canada Inc., Bayer HealthCare, and Biogen are manufacturing Interferon beta.

The overall world market measurement of a number of sclerosis is price 24.8 billion USD by 2024 (Supply:https://www.thepharmaletter.com/article/multiple-sclerosis-therapeutics-market-to-be-worth-24-8-billion-by-2024) and Interferon-β in 2015 was U$6.3 billion USD (Supply: http://www.researchandmarkets.com/reviews/2221752/interferon_market_forecast_to_2015.pdf).

Dr. Sang Mok Lee, the CEO of Biocure, accomplished a preclinical check for this product earlier in 2001 earlier than he established Biocure, however he couldn’t full a scientific check attributable to a small variety of sufferers in Korea at the moment. Biocure accomplished one other preclinical check in 2008, however once more couldn’t advance to a scientific check attributable to lack of funds.

Biocure has accomplished with a preclinical check once more in Korea in 2019 , as Interferon-beta shall be the primary one to be commercialized out of Biocure’s product portfolio. . Since Korea doesn’t have a ample variety of sufferers for a scientific check, Biocure will submit the applying to Korea FDA for the implementation of scientific check in different international locations with extra sufferers. Upon the consent from Korea FDA, Biocure plans to hold out a scientific check in Europe or Canada, topic to fund availability. . The estimated price of preclinical and scientific check could be KRW 3 Billion, however it could actually fluctuate relying on the principles and regulation of authorities in every nation. The fee estimation is beneath progress.

As soon as scientific check out of the country is full, Biocure shall be capable to receive a product registration from Korea FDA with such scientific check outcomes. An approval from Korea FDA will enable Biocure to begin business manufacturing in Korea and export to different international locations. With a view to market this product to different international locations reminiscent of Europe or Canada , an analogous product registration procedures needs to be taken with native authorities. Nonetheless, it might be a lot faster and simpler with an approval from Korea FDA. As an alternative of a full scale of scientific check outcomes, a Bridge Check or a Racial Distinction Check may very well be acceptable to acquire a product registration.

Biocure plans to generate income by manufacturing Interferon-beta on the GMP facility in Korea and exporting to abroad the place merchandise are registered. The last word plan of Biocure is constructing an area GMP facility in these international locations by the Joint Enterprise with dependable native companions who’re keen to finance the development of GMP Facility. Then, Biocure might safe a secure money move from expertise switch charges, royalties and dividends.

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2. Ranibizumab

Ranibizumab is used for treating macular degeneration. It’s also used to deal with a sort of eye downside referred to as macular edema. Ranibizumab (commerce title Lucentis amongst others) is a monoclonal antibody fragment (Fab) created from the identical father or mother mouse antibody as bevacizumab. It’s an anti-angiogenicthat has been accredited to deal with the “moist” kind of age-relatedmacular degeneration (AMD, additionally ARMD), a typical type of age-relatedvision loss.

Its effectiveness is much like that of bevacizumab. Its charges of unwanted effects additionally seem comparable. Nonetheless, ranibizumab sometimes prices $2,000 a dose, whereas the equal dose of bevacizumab sometimes prices $50.

Ranibizumab was developed by Genentech and is marketed in the US by Genentech and elsewhere by Novartis, beneath the model title Lucentis, and the patent expired in 2017. The overall market measurement of Lucentis is estimated US$4.3 billion in 2013.

The variety of sufferers who want Ranibizumab in Korea is on the rise and its annual development fee is 38%, the world’s highest. (Supply: Statistic Bureau,MIC;Ministry of Well being, Labour and Welfare, United Nations) The common market value is thought to be US$1,200 per vial. (Supply: https://www.medicine.com/price-guide/lucentis)Due to its excessive value, Medical Service Plan or Nationwide Well being Insurance coverage Program has a restrict to cowl the fee for the wanted sufferers and only a few sufferers obtain advantages for this drugs.

When Biocure manufactures this product on the GMP facility in Korea, the anticipated promoting value may very well be diminished to lower than 50% of the present market value, if required. The value competitiveness of a biosimilar towards the unique product is usually very excessive. For the reason that Korean marketplace for this product is rising quick, its business manufacturing in Korea might deliver the Firm good money flows and a excessive likelihood to enter into the overseasmarket.

3. Filgrastim

Filgrastim is used to deal with neutropenia, an absence of sure white blood cells brought on by most cancers, bone marrow transplant, chemotherapy, or by different situations. It’s a kind of anti-cancer remedy which performs an necessary function for restoration of immunity for most cancers sufferers.

The unique product developer was Amgen, USA and its patent expired in 2013. Due to this fact, many biosimilar producers exist all through the world already.

With the completion of product growth, Biocure can begin preclinical checks at any time. However the Firm is evaluating a proper timing to begin attributable to its precedence towards different merchandise of the Firm, contemplating of restricted fund availability and monetary constraints.

The Firm plans to begin a preclinical and scientific check in Korea first and collaborate with native events in different international locations, whoever the Firm might enter into an settlement with first.

When Biocure discusses about biosimilar expertise switch or GMP facility JV, Filgrastim is included within the goal product portfolio for native manufacturing.

4. CAR T Cell Remedy

The Firm by its wholly owned subsidiary BiocurePharm Company (“Biocure Korea”) has entered right into a joint R&D settlement with Pharos Vaccine Inc. dated November 30, 2017 for the aim of finishing up analysis and growth actions regarding the commercialization of anti-CD19CAR-T (Chimeric Antigen Receptor T Cell) and for the pursuit of pre-clinical and scientific trials.

In August 2017, Novartis Prescription drugs Corp. was the primary firm to acquire FDA approval for gene immune- remedy in the US with its product “Kymriah”, which is for utilization in remedy of pediatric and younger grownup sufferers with a type of acute lymphoblastic leukemia. Kymriah is a CAR-T cell remedy product. In October 2017, Gilead Sciences Inc. obtained FDA approval for its lymphoma product “Yescarta” one other CAR-T cell remedy product used to deal with grownup sufferers with sure sorts of non-Hodgkin lymphoma.

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The marketplace for CAR-T Cell therapies is predicted to develop steadily until 2028 by 53.9% of annual development fee and attain U$8.3 Billion in worth. (Supply: Coherent Market Perception, CAR-T Cell Remedy Market, 2017. 2)

Chimeric Antigen Receptor modified T cell immunotherapy, so referred to as, CAR-T Cell Remedy, is among the best and superior remedies for Acute Lymphoblastic Leukemia (ALL). Particular antigen receptor of CART cell is made by use of virus vector after extracting T cell from affected person bloods, and re-infuse to affected person. Throughout the affected person’s physique, the CAR-T cells have the potential to acknowledge the most cancers cells and different cells expressing a selected antigen and fix to them, which can provoke direct cell dying.

Relapsed and refractory acute lymphoblastic leukemia (ALL) stays to be a major reason behind most cancers related morbidity and mortality for kids and adults. CAR-T cell remedy, as one of the promising focused immunotherapies, has drawn intensive consideration and resulted in a number of purposes. Biocure Korea have established pre-clinical and scientific designs of 2nd era CAR-T cell immunotherapy in 2017: customary protocol for conditioning and infusion, higher management of problems, and mixture with different therapeutic choices and and many others. On July 5, 2018, the Firm’s wholly owned subsidiary, BiocurePharm Corp. (BP Korea), has began conducting a preclinical trial of its CAR-T cell. On October 16, 2018, the Firm launched profitable outcomes of the preclinical trial of its CAR-T cell. Achievements have made by the Firm updated are together with, however not restricted to, Medical trial protocol, Development of grasp cell financial institution, Institution of producing course of, Stability check, Institution of high quality management, Specification and Assay. GMP documentation, Validation of producing course of, Validation of High quality management and high quality assurance, CMC assay for scientific trial samples, documentation for scientific trial applicant and so forth.

It’s anticipated to assist a variety of leukemia sufferers. In keeping with the NIH, greater than 340,000 folks within the U.S. suffered from leukemia in 2015. World CAR-T Cell therapeutics market was $72 million in 2017. Within the subsequent 11 years (from 2017~2028), the annual development fee will steadily improve to 53.9%. (Coherent Market Insights, CAR-T Cell remedy market (2017.2)) CAR-T Cell therapeutics is predicted to generate enormous income alternatives in business.

The Firm is in a center of Investigational New Drug (IND) utility course of with Korean FDA and count on to begin scientific trials in Korea inside the first quarter of 2021. Two main hospitals in Seoul, Korea shall be the place for scientific trial.

5. Foot-and-mouth Illness (FMD) Vaccine

Pharos Vaccine Inc. has succeeded in growing a complicated recombinant vaccine utilizing E. coli as a substitute of manufacturing the vaccine by present cell tradition. Pharos Vaccine has the flexibility to fabricate personalized vaccines that match foot-and-mouth illness virus sorts. It makes use of Escherichia coli for manufacturing and its manufacturing price is far lower than that of cell tradition, subsequently it might be capable to produce the big portions inside a shorter interval at far more reasonably priced value.

Pharos Vaccine Inc. doesn’t have ample sources to fabricate any merchandise at business scale regardless of its personal progressive expertise. Pharos primarily focuses on analysis & growth and doesn’t have any advertising expertise or sources within the worldwide market. Due to this fact, Biocure and Pharos have agreed to cooperate to enter into abroad markets by Biocure’s worldwide enterprise experience and Biocure’s accessibility to a GMP facility for biosimilars.

Pharos Vaccine Inc. has developed Foot-and-Mouth Illness (FMD) vaccine in 2015 and Biocure has a license settlement with Pharos to provide and market FMD vaccine to Korea and abroad, besides China for 10- years from the product registration date.

The Korean Foot-and-Mouth Illness (FMD) vaccine market is price about KRW60 billion a yr. Merial, a UK based mostly multinational pharmaceutical firm, gives bulk vaccine to 6 native animal vaccine producers in Korea. The six native producers repack the vaccines beneath their very own manufacturers and ship them to the Korean Public Procurement Providers.

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