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- 2026-03-17 23:19:11
- Company
- Novartis Korea appoints Byungjae Yoo as new head
- by Eo, Yun-Ho Sep 15, 2021 06:11am
- Byungjae Yoo, new General Manger of Novartis Korea Byungjae Yoo, the former Managing Director of Johnson & Johnson Medical North Asia, has been appointed as the new head to lead Novartis Korea. The company had recently announced through an internal notice that Yoo will be officially appointed as its General Manager from October 1st. This will be the second time since the company's establishment that the Korean subsidiary will be managed by a Korean leader. After completing his MBA at Harvard Business School, the newly appointed General Manager Yoo had joined J&J in 2006 through the company’s International Recruitment & Development Program. Since then, Yoo had held various roles in the company, including ones in North America’s Endovascular team, DePuy UK, and DePuy Australia. In Korea, he had served in the Cardiovascular Care Business Unit across North Asia and then appointed the Managing Director of Johnson & Johnson North Asia to oversee Korea, Taiwan, and Hong Kong. Although Novartis has been operating its oncology and pharmaceutical division independently as separate divisions, with reimbursement discussions for the CAR-T therapy ‘Kymriah (tisagenlecleucel)’ and SMA treatment ‘Zolgensma’ in progress, on what synergy will the appointed new head bring remains to be seen. Since its establishment in 1997 and the first president Frans Hompe, the company had mostly appointed foreign heads to lead the Korean subsidiary, including Jean-Luc Scalabre in 1998, Peter Maag in 2003, Andrin Oswald in 2006, Peter Jager in 2008, Brian Galdsden in 2014, and most recently, Joshi Venugopal. The only Korean national that had been appointed until now was Hak-sun Moon in 2015.
- Company
- Pharma companies fail to suspend renegotiations for CAs
- by Chon, Seung-Hyun Sep 15, 2021 06:11am
- Once again, the suspension of execution for the second negotiation order to retrieve reimbursement that was paid for choline alfoscerate (cholinergic agent) that was filed by pharmaceutical companies was dismissed. In other words, the companies have failed to suspend the execution of both the first and second negotiation order to retrieve reimbursement. According to industry sources on the 14th, the 9th Administrative Branch of the Seoul High Court dismissed the appeal to suspend execution of the order for renegotiations on choline alfoscerate products that was filed by 26 companies including Chong Kun Dang on the 8th. The suit was filed for the second negotiation order that was issued by the government to negotiate the terms for retrieving the reimbursement paid for choline alfoscerate drugs. At the end of last year, the Ministry of Health and Welfare ordered the National Health Insurance Service to make insurance retrieval agreements on choline alfoscerate drugs. The order was to reach agreements with the companies that ‘If the clinical trial fails, the full amount of health insurance prescriptions, from the date the clinical trial design submission was submitted to the MFDS to the date of indication removal, should be returned to the NHIS,.’ After the companies refused to negotiate, the MOHW again ordered renegotiations in June last year. Upon order, two groups consisting of 26 companies including Daewoong Bio and 26 companies including Chong Kun Dang filed for the cancellation and suspension of execution of renegotiations. In July, the suspension of execution filed by Daewoong Bio and others was dismissed, and the suspension of execution of negotiations filed by Chong Kun Dang and others was also dismissed. Chong Kun Dang and others again re-appealed but the case was again dismissed. As a result, all pharmaceutical companies that requested suspension of executions failed to suspend renegotiations for reimbursement retrieval. Prior to the second try, the companies had filed administrative suits and suspension of execution for the first renegotiation order as well. At that time, two groups consisting of 28 companies including Daewoong Bio and 28 companies including Chong Kun Dang separately filed their cases, but both cases were dismissed by the Supreme Court. The suspension of execution filed by Chong Kun Dang, etc. was first dismissed in January, then again dismissed at the appeal hearing in May. Chong Kun Dang and others filed for a reappeal, and but this was again dismissed last month. The suspension of execution filed by Daewoong Bio and others was dismissed at the first and second trial and then dismissed again by the Supreme Court in July without hearing as discontinuance of a trial. Meanwhile, the companies have also reached an agreement with the NHIS to negotiate for the retrieval of reimbursement. Recently, the NHIS had reached an oral agreement for negotiations with companies to retrieve the reimbursement paid for choline alfoscerate drugs. The NHIS and the companies agreed that the companies will back 20% of the health insurance prescriptions amount paid from the date of submission of the clinical trial design to the MFDS to the date of indication removal if the clinical trial on choline alfoscerate drugs fail and its indication is deleted. However, despite reaching such agreements, the companies are continuing with litigations to defer negotiations. The companies have filed all-round lawsuits, including suits for cancellation and suspension of execution to block negotiations, but none were dropped since.
- Company
- Who is the winner of the domestic toxin in the US market?
- by Nho, Byung Chul Sep 14, 2021 05:55am
- As Medy Tox received the rights of the improved botulinum toxin candidate MT10109L from AbbVie on the 8th, competition in the U.S. market for domestic Toxin companies is expected to intensify. The size of the US botulinum toxin market is about 2 trillion won, the largest sales in the world. For Korean companies, the United States is an essential country to expand global sales. Currently, Daewoong's Nabota (Jubo) is the only domestic product that is officially distributed. Hugel also submitted an application for an item license for Letybo 50 and 100 units to the U.S. Food and Drug Administration (FDA) in April this year, making it visible to enter the U.S. market directly through Hugel America. Hugel and Daewoong are entering the U.S. market. On the 8th, Medy Tox rights return and license contract for the neurotoxin candidate MT10109L signed with Allergan was terminated. With the contract signed in 2013, Allergan (AbbVie) will transfer all rights, including clinical data conducted by Allergan, to Medy Tox. Shinhan Financial Investment announced on the 9th that Medy Tox is likely to proceed with its own licensing process, and that it is also possible to sell botulinum toxin products by Medy Tox through Evolution. In fact, Medy Tox is currently the largest shareholder with a 13.7% stake in Evolus. Daewoong said in a statement on the 10th, "The possibility of selling Evolus in a report issued by Shinhan Financial Investment on the 9th is clearly false," adding, "Evolus can never handle competitors other than Nabota under a botulinum toxin exclusive license contract with Daewoong." All of these are disclosed in the disclosure data." In July, USPTO PTAB sided with Galderma, a Swiss pharmaceutical company, in 2019 regarding the long lasting effect of new botulinum toxin formulations patent registered in the U.S. by Medy Tox in 2018. Medy Tox said in a statement at the time, "The results of the first trial on Galderma's patent objection have been released, and we are considering applying for a review to maintain the patent." It has nothing to do with the production or sale of our products developed with the technology, he said. However, in the same month, Revance Therapheutics, a U.S. botulinum toxin company, also raised the issue of Patent No. 9480731, which includes the long lasting effect of new botulinum toxin formulations, to USPTO PTAB. An official from the pharmaceutical industry said, "Repeated lawsuits related to text between domestic companies in the global market, including Korea, can only provide opportunities to competing multinational companies. In particular, this method should be avoided to prevent negative perceptions of Korean healthcare companies in the global market."
- Company
- Pharmaceutical companies lost the impurity valsartan lawsuit
- by Kim, Jin-Gu Sep 14, 2021 05:55am
- The government won a lawsuit filed by the government and the pharmaceutical industry over the cost-responsibility issue of follow-up measures for impurity drugs. On the 9th, the Civil Affairs Division 21 of the Seoul Central District Court sided with the NHIS in a lawsuit filed by Daewon Pharmaceutical and 35 other companies against the NHIS. Pharmaceutical companies participating in the lawsuit must pay each reimbursement claimed by the NHIS unless they appeal separately. In addition, pharmaceutical companies must pay for the litigation. The case originated when the NHIS claimed reimbursement from 69 pharmaceutical companies in October 2019. The total amount of compensation was 2.03 billion won. The plan is to return health insurance finances paid as follow-up measures during the 2018 Valsartan crisis from pharmaceutical companies. The NHIS was working on exchanging impurity drugs prescribed to existing patients with new drugs. Pharmaceutical companies that protested the NHIS measure filed a lawsuit. Pharmaceutical companies claimed that unexpected impurities have become newly recognized with the development of science, and that it is excessive to pay indemnity as they were manufactured in a legitimate process. The lawsuit drew keen attention from the pharmaceutical industry in that impurities were detected in Ranitidine, Metformin, Losartan, and Irbesartan after the Valsartan crisis. This is because the outcome of the lawsuit is likely to determine the responsibility for the impurity crisis in the future.
- Company
- K-mRNA Consortium support group to gain momentum
- by Nho, Byung Chul Sep 13, 2021 05:57am
- The research and development move of the K-mRNA Consortium formed to develop the next-generation COVID-19 vaccine is expected to gain further momentum. The consortium consisting of Hanmi, ST Pharm, GC Pharma and KIMCo announced on the 9th that Dong-A ST, a major pharmaceutical company in the development and production of specialized drugs in Korea, and E-Cell, a company specializing in bio-original materials, participated in the consortium. Since the launch of the consortium in June, the progress of the project has accelerated, and material companies and others seem to be joining as partners. Dong-A ST is one of the representative pharmaceutical R&D companies in the domestic pharmaceutical bio industry, and will actively support the consortium's future application for approval of mRNA vaccines, clinical development, and licensing based on its rich experience and capabilities. E-Cell is Korea's first leading bio-materials, parts, and equipment company that developed disposable bio-processing equipment and consumables such as disposable cell culture devices and disposable mixer bags. At the time of launch, the consortium, which announced that it would expand additional participation from raw and subsidiary materials companies, universities, and research institutes, plans to open the door to companies that can play a role in the rapid implementation of the successful model of the entire cycle. Currently, the consortium is developing the COVID-19 mRNA vaccine candidate STP2104 with the aim of entering phase 1 clinical trial within the year and commercializing it following conditional permission in the first half of next year. The consortium is managing its schedule without a hitch, such as regularly sharing information and consulting with the MFDS every month for rapid clinical implementation. In addition, it is preparing to establish a production system of 100 million doses of mRNA vaccine, which is the national vaccination volume, by the end of 2022. In addition, a separate COVID-19 vaccine is being developed to respond to the delta mutation virus. In this regard, ST Pharm, which is in charge of the consortium's clinical part, is conducting a preclinical efficacy evaluation after selecting an additional mRNA vaccine candidate, STP2130.
- Company
- Pharma companies speed up delivery of urology combo drugs
- by Kim, Jin-Gu Sep 13, 2021 05:56am
- Korean pharmaceutical companies have been rushing to develop combination treatments for various urologic diseases, such as those for prostatic hypertrophy+erectile dysfunction or benign prostatic hyperplasia+overactive bladder. Many patients with urogenital disorders suffer various conditions at once, including enlarged prostate, erectile dysfunction, overactive bladder, etc. The market size for the single-therapy agents that treat each separate condition is considerable. With no other combination therapy than Hanmi’s ‘Gugutams’ authorized in Korea, the industry’s interest in the combo drug market has been rising. Pic of Hanmi Pharm As of the 13th, the only drug approved as a combination therapy for hypertrophy+erectile dysfunction in Korea by the Ministry of Food and Drug Safety is Hanmi Pharmaceutical's ‘Gugutams.’ Gugutams is a combination of the prostate treatment ‘tamsulosin’ and erectile dysfunction treatment ‘tadalafil.’ At the time of its release in 2016, Gugutam’s performance did not meet expectations, due to low awareness of the urogenital disease in general. However, with increased awareness, the product became a steady seller, reaching ₩2.1 billion in sales last year. On this, Dongkook Pharmaceutical and Yuyu Pharma have jumped in to compete in the combination treatment market for benign prostatic hyperplasia+erectile dysfunction that combines tadalafil with ‘dutasteride,’ which is another ingredient used for benign prostatic hyperplasia. No combination treatment has yet been approved for this combination in Korea. Dongkook Pharmaceutical has started Phase III clinical trials on its dutasteride+tadalfil combo, ‘DKF-313,’ earlier this month at the Seoul Asan Medical Center. The company expects the Phase III trials to be complete by the end of next year. Yuyu Pharma is also developing a combination therapy using the same two ingredients. The company received approval for the Phase III trial in 2018, however, before starting the Phase III trial, a need to change the formulation was raised, and the company decided to start over from Phase I. Also, the development of combination treatments for benign prostatic hyperplasia+overactive bladder is actively underway. KyungDong Pharm and Dongkoo Bio&Pharma are competing to develop the combo treatment. In March this year, KyungDong Pharm received approval to start Phase III trials for its ‘KDF1905,’ which combines the benign prostatic treatment tamsulosin with overactive bladder treatment ‘mirabegron.’ Dongkoo Bio&Pharma had also previously received approval for the Phase III trial of its tamsulosin+mirabegron combination in January last year. Ildong Pharmaceutical and Jeil Pharmaceutical had also developed combinations using tamsulosin and another overactive bladder treatment ‘solifenacin.’ The two companies have completed Phase III trials for their combinations. However, Ildong Pharmaceutical decided to discontinue the development of its drug last year. Jeil Pharmaceutical had not applied for the marketing authorization of its drug for over 2 years since the completion of its Phase III trial. Also, CTC Bio’s development of its combination treatment for premature ejaculation+ erectile dysfunction is in its final stages. It is a combination of the premature ejaculation treatment ‘clomipramine’ and the erectile dysfunction treatment sildenafil. The company plans to apply for marketing authorization of its combination drug after completing its Phase III trial within this year.
- Company
- Jardiance marks new milestone in heart failure treatment
- by Whang, byung-woo Sep 13, 2021 05:55am
- With the SGLT-2 inhibitor, Jardiance (empagliflozin), proving its efficacy in heart failure with preserved ejection fraction (HFpEF), on how it will affect the domestic prescription market for heart failure is gaining attention. As another SGLT-2 inhibitor, Forxiga (dapagliflozin), was the first to receive approval for heart failure with reduced ejection fraction (HFrEF) indication, whether Jardiance’s study results could become the solid blow that could overturn the drugs' positions is gaining industry interest. The competition among SGLT-2is that are expanding their indications from their existing diabetes indications to heart failure as well as chronic diseases is also a special point of interest. The full results of the EMPEROR-Preserved clinical trial that demonstrated Jardiance’s effect on heart failure were presented recently at the ESC Congress 2021. The study showed a 21% reduction in the relative risk of cardiovascular death or hospitalization using Jardiance in HFpEF patients with or without diabetes compared to placebo, meeting its composite primary outcome. Also, in the analysis of its major secondary endpoint, Jardiance reduced the relative risk of first and recurrent heart failure hospitalization by 27%, and significantly delayed kidney function decline. On this, Jung-Woo Son, Professor of Cardiology at Wonju Severance Hospital, said, “It is encouraging that a treatment had been able to meet its primary outcome in HFpEF, in the midst of all other trials failing development for the condition. The outcomes with regards to cardiovascular deaths were a little disappointing, but the results showed enough benefit in other areas.” Dong-Ju Choi, President of the Korean Society of Heart Failure who participated as the head coordinator in the trial, stressed that the study reflected Korea’s heart failure treatment environment as 13 Korean medical institutions participated in EMPEROR-Preserved trial. With such strengths, the sentiment in the field is that there is no reason not to prescribe Jardiance after its approval as the clinical benefits are clear. However, how the prescription patterns will change will need to be observed in comparison to Forxiga, which was approved for HFrEF. A cardiology professor from a tertiary hospital in Korea who requested animosity said, “The good performance shown by Forxiga and Jardiance, has even raised discussions on their class effect. Since we have already been using Forxiga for HFrEF, doctors will be preferring Forxiga for the time being, however, there is a possibility that Jardiance will attract attention due to its versatility.” In particular, the professor predicted prescription of Jardiance would increase for patients whose diagnosis between HFrEF and HFpEF is unclear. He said, “There are heart failure patients who belong in the range between HFrEF and HFpEF, and Jardiance will have an advantage in preoccupying this market as it has presented results for both HFrEF and HFpEF. However, I know Forxiga is also conducting studies to cover the relevant areas, so on how the results will be remain to be seen.” As such, the majority of the HCPs in Korea are positive about the performance and expandability of SGLT-2is in heart failure. Therefore, the only barrier is in the drugs' progress in receiving approval and reimbursement. Forxiga is currently approved for HFrEF but is not reimbursed yet. And Jardiance is aiming to gain approval for its HFpEF indication based on its EMPEROR-Reduced trial within this year. Some industry experts have cautiously anticipated that the two drugs may be concurrently approved for reimbursement after Jardiance is approved for its HFpEF indication. Also, Boehringer Ingelheim and Lilly plan to submit the HFpEF results from their clinical trial to regulatory authorities within the year, but considering the domestic situation in which approval for drugs is processed only after FDA approval, it is unclear whether the drug will immediately be approved for prescriptions. Another variable that exists is Entresto. Novartis has applied for approval to expand the drug’s indication to the HFpEF indication.
- Company
- Key 3 mRNA vaccine techs are not Moderna's nor Pfizer's
- by Kim, Jin-Gu Sep 10, 2021 05:58am
- The three key technologies required for developing mRNA vaccines were revealed. These are technologies related to antigen optimization, mRNA syntehsis·modification, and manufacture of lipid nanoparticles (LNP) that correspond to steps 1, 2, and 4 of the 5-step vaccine manufacturing process. The explanation was that a biopharmaceutical company aiming to develop COVID-19 vaccines or anticancer treatments using mRNA must secure the technologies mentioned above. Even Pfizer and Modera, which produce the mRNA COVID-19 vaccines, are said to have secured patents related to the abovementioned technology through a licensing agreement. On the 8th, the Korean Intellectual Property Office (KIPO) published an ‘mRNA Vaccine Patent Analysis Report' and introduced the key technologies required for the production of mRNA vaccines. According to the report, a total of 691 mRNA vaccine-related patent applications have been filed globally. Moderna had filed for the most with 211, followed by CureVac’s 108, TranslateBio’s 67, Pfizer·BioNTech’s 60, and GSK’s 25 applications. However, the report showed that the core patent required for the production of mRNA vaccines is not owned by Pfizer nor Moderna. mRNA vaccines are produced in five steps: ▲antigen optimization ▲mRNA synthesis and modification ▲ Separation & Purification ▲LNP production ▲formulation. Among these, technologies for antigen optimization, mRNA synthesis and modification, and LNP production are the key technologies required for vaccine production. Map of COVID-19 mRNA vaccine technology relationships between companies (Source: KIPO) The technology for antigen optimization is owned by the US National Institute of Health (NIH). NIH had applied for 3 patents on ‘COVID-19 spike protein antigens,’ and one of the three has been registered in the US. Companies that develop mRNA COVID-19 vaccines like Pfizer·BioNTech, Sanofi, and GSK have signed licensing agreements with the NIH for the relevant patent. It is not confirmed whether Moderna, which had jointly developed a COVID-19 vaccine with NIH, had signed a licensing agreement for the said patent. In mRNA syntehsis·modification, patents on the ‘modified nucleic acid’ is key. Cellscript owns the patent on ‘the method reducing immunogenicity using pseudouridine.’ The patent, which had previously been owned by the University of Pennsylvania, was transferred to Cellscript. Moderna and BioNTech secured the technology through a licensing agreement with Cellscript. Two companies have the key technology related to lipid nanoparticles as patents- ‘Arbutus’ and ‘Acuitas.’ Arbutus owns multiple patents on “lipid-nucleic acid particle composition containing cationic lipids,’ and Acuitas owns multiple patents related to ‘lipid-nucleic acid particles containing cationic lipids and PEG-Lipid.’ Both play a vital role in the manufacturing of lipid nanoparticles. Pfizer·BioNTech had signed a license agreement with both companies to secure the technology. On the other hand, Moderna only signed a license agreement with Acuitas Therapeutics and is in a patent dispute with Arbutus in the US and Europe with regards to the technology. KIPO said, “Korean pharmaceutical companies and research institutions wishing to develop mRNA vaccines would need to acquire or evade the license of these patents. However, only 17% of the 691 patents related to mRNA are registered in Korea, therefore, Korean mRNA vaccine developers are less likely to get embroiled in patent dispute compared to those in the US or Europe.”
- Company
- Medytox’s American dream falters with returned botox rights
- by Kim, Jin-Gu Sep 09, 2021 05:55am
- Medytox’s plans to overcome the license revocation in Korea by entering the US market, have come to a halt with AbbVie, which had been conducting global trials for the new botulinum toxin candidate 'MT10109L,’ returning its rights to Medytox. ◆A technology export agreement worth up to ₩400 billion was returned in 8 years On the 8th, Medytox announced that AbbVie has returned the rights concerning MT10109L, an improved botulinum toxin candidate, to its company. The right was returned in 8 years since the technology export. Medytox had signed a licensing-out agreement for its botulinum toxin candidate in 2013 to Allergan (now AbbVie) and handed over the global development and sales right of its product in all countries around the world than Korea and Japan. The agreement including the signing fee and milestone was worth $362 million (₩390 billion) The returned rights by themselves are not bad news to Medytox, as the company has no obligations to return the $100 million (₩120 billion) that it received during the term of the contract. The company had received $65 million upon signing the agreement, and an additional $35 million milestone. company However, the returned rights could be a serious blow considering Medytox’s current circumstances. Medotx’s 6 botulinum toxin products are all on the verge of license revocations. The Ministry of Food and Drug Safety had ordered the disposition to suspend sales and cancel licenses of Medytoxin 50·100·150·200, as well as Coretox, and Innotox. The court accepted Medytox’s request to suspend the execution of the administrative order, however, the MFDS’s disposition served as a major negative factor on Medytox. Medytox earned ₩140.8 billion last year, which was a 32% decrease from the previous year. To Medytox, MT10109L was the key substance that could save the company from the looming crisis. The plan was for MT10109L to enter the US market through AbbVie to overcome the crisis of license revocation in Korea. In addition, the company had planned to use the FDA approval as momentum to receive authorization for MT10109L as a new product. Until earlier this year, the plan seemed to be in smooth progress. AbbVie had started 4 global Phase III trials on a total of 1,308 subjects in December 2018. The trials were completed in March this year. The industry had expected AbbVie to submit a Biologics License Application (BLA) to the US FDA within this year. However, contrary to industry belief, AbbVie suddenly returned its rights to Medytox., putting a stop to Medytox’s plans to enter the US market. ◆Why did AbbVie return the rights after completing Phase III trials? The industry has been speculating on two reasons as to why the company had returned the rights to MT10109L after completing Phase III trials. One is the possibility of trial failure. The results of the Phase III trial may not have been satisfactory, which led to the return of rights of MT10109L to Medytox. The other is the poor relationship it has with Daewoong Pharmaceuticals. In May, Daewoong Pharmaceuticals had submitted an investigation request into MT10109L claiming that its data has been manipulated. Its argument was that MT10109L is the same product as the Innotox that was revoked in Korea, and that Innotox’s data was found to be manipulated during the MFDS investigation. On this, Medytox had refuted the claim, saying that MT10109L is a new botulinum toxin formulation and a clearly different product from Innotox. Innotox is a domestically sold pharmaceutical that complies with the MFDS regulations, however, MT10109L is a product designed for approval in the US and Europe, and is manufactured and produced in compliance with the regulations in those countries. An industry official said, “AbbVie may have determined MT10109L the same substance as Innotox. And even if the company decided the two were not the same, the FDA’s move to launch an investigation into the drug may have been a burden.” Medytox plans to soon decide whether to apply for authorization of the retrieved MT10109L in the US. A company official explained that although the rights were returned from AbbVie, the possibility of applying for approval remains as the development of the product has not been aborted. An official from Medytox said, “We have received the full clinical data from Abbvie. We will be reviewing entry into the global market while conducting data analysis. We have not decided whether to directly apply for approval or seek a new partner. It’s all being reviewed internally.”
- Company
- Genome & Co acquires US firm to enter CDMO business
- by An, Kyung-Jin Sep 09, 2021 05:55am
- The KOSDAQ listed Genome & Company has acquired a manufacturing facility in the US to enter the microbiome contract development and manufacturing organization (CDMO) business. Through the acquire, the company aims to rise to a leader in both R&D and production in the microbiome market, a field with high growth potential. On the 8th, Genome & Company announced that it had acquired 966,502 shares of List Labs in the US in cash. This is equivalent to 27.17% of the company’s net worth. To internalize the production of microbiome treatment and diversify the company’s business, Genome & Company acquired 60% of List Lab’s shares and became the major shareholder of List Labs Genome & Company is a biotech company that specializes in new drug development. It was listed on KOSDAQ in December last year. The company has been using microbiomes to develop immunotherapy drugs for cancer and treatment for autism, as well as new antibody therapies. List Lab is a specialized CDMO business with 43 years of history. It owns a 2498m² sized FDA cGMP certified facility in San Jose, California that produces consigned microbiomes and biotoxins. The company had accrued an average of $9.7 million in sales annually. The company’s operation of 7 independent manufacturing spaces within the facility was positively reviewed as it allows separate production of aerobic and anaerobic microbiome-based drugs. List Labs’ manufacturing facility (Source: Genome & Company) Genome & Company’s management held an online discussion session to explain the company’s mid-to-long term vision regarding its entry into the new business area. By incorporating List Labs as the company’s subsidiary, the company aims to internalize the production of its self-developed microbiome pipeline and more stably operate clinical trials. Even after acquiring the management rights, the management said that List Lab will maintain its independent operations but expand new production facilities to increase the size of the business. The company plans to become a global microbiome CDMO leader by expanding its business area from the existing model that focused on early-phase clinical trials to late-phase clinical trials and consignment production for commercial use. The company also mentioned that it is considering listing Lists Lab on NASDAQ or other markets after the global CDMO business is in place. Microbiomes refer to a community of microorganisms. With increasing interest and attempts to affect the creation of the microbial environment for use in rare disease and cancer treatment, the microbiome industry has emerged into a blue ocean in the field of new drug development. Genome & Company expects the demand for production capacity to rise steadily in line with the continued rapid growth of the microbiome treatment market. According to the Ministry of Food and Drug Safety data, 204 microbiome treatments are currently being developed worldwide. The market size is expected to increase approximately 167 times, from $56.3 million(₩62.4 billion) in 2018 to $9.38 billion (₩10.87 trillion) in 2024. Jisoo Pae, CEO of Genome & Company who attended the session said, “Success of a microbiome-based new drug development depends on its prompt release and market preoccupation. I believe securing a CDMO will become an important factor for success in the microbiome market," He also expressed his expectations that the company’s entry into the microbiome CDMO business will add a new profit model to the company, increasing the speed of new drug development, and ultimately push the company up to a ‘first-mover’ in the global microbiome industry. Genome & Company’s microbiome CDMO project plan (Source: Genome & Company) The management had stressed that the ₩30 billion paid out in the acquisition process was 100% self-funded. The company does not plan to receive investment from external institutional investors nor intend to issue new shares. Pae emphasized, “The few media reports that Genome & Company plans to make paid-in capital increases because of the acquisition are not true. However, we may need to attract investment to expand the factory in the U.S. However, we will be attracting investments around List Labs and the U.S. subsidiary, therefore the HQ’s equity will not be affected or diluted in any way.”
