[제약 바이오 이모저모] Ministry of Food and Drug Safety initiated the procedure for canceling Medytox Botox Innotox

[이데일리 노희준 기자] This is the news that attracted attention in the pharmaceutical and bio industry for one week (December 21st-December 24th).

△ The Ministry of Food and Drug Safety stops manufacturing, selling, and using Medytox Botox Innotox

The Ministry of Food and Drug Safety announced on the 22nd that it would temporarily suspend the manufacture, sale, and use of Innotox, a liquid botulinum toxin product manufactured by Medytox, and initiate administrative disposition procedures such as cancellation of product permission. This disposition is based on the results of the prosecution’s investigation into the suspicion of manipulation of documents for permission submission by Innotox, which was reported to the National Rights Commission as a public interest report. The prosecution recently confirmed the violation of forged safety test data in the course of Meditox’s drug product permission and change permission, and prosecuted it for obstructing the execution of public affairs by hierarchies under Article 137 of the Penal Code.

On the 23rd, Medytox apologized to customers and shareholders for the provisional order to suspend manufacture, sale, and use of Innotox by the Ministry of Food and Drug Safety. In addition, on the 23rd, it immediately filed a lawsuit for suspension of execution and cancellation. If even Innotox is canceled, all three products (Meditoxin, Inotox, Coretox) owned by Medytox will be subject to cancellation. Medytox has filed a lawsuit for cancellation of Meditoxin and Innotox, and continues to sell its products by leading the court to suspend execution.

△ Daewoong Pharmaceutical “Corona treatment, main endpoint is not statistically significant”

In phase 2a of this clinical trial, which is developing’Hoystar tablet’, an existing chronic pancreatitis treatment, as a treatment for COVID-19, it failed to secure the statistical significance of the main endpoint. Daewoong Pharmaceutical announced on the 23rd the results of the phase 2a clinical topline on the effects of Hoystar tablets on the treatment of Corona 19. The top line is rough data that can determine the success or failure of a clinical trial. Daewoong Pharmaceutical said, “The time taken until the virus negative prevalence, the main evaluation variable, was not statistically significant, but the rate at which the virus was removed tended to be faster in the Hoystar group than in the placebo group.”

△ The Ministry of Food and Drug Safety begins preliminary review of Janssen’s Corona 19 vaccine

The Ministry of Food and Drug Safety announced on the 22nd that Janssen (Johnson & Johnson) had applied for a preliminary review before applying for a COVID-19 vaccine. Janssen submitted nonclinical, quality data on the vaccine. This vaccine is one of the vaccines announced by the government. Accordingly, the’Virus Vector Vaccine Team’, which is an exclusive license review team of the Ministry of Food and Drug Safety, will carefully review the toxicity, pharmacological and quality data of the vaccine in advance. The Ministry of Food and Drug Safety is operating the Viral Vector Vaccine Team and Nucleic Acid Vaccine Team, which are exclusively licensed teams in preparation for domestic approval applications for Corona 19 vaccine.

△ Medipost transfers cell culture platform technology to LG Chem

Announced on the 23rd that it has signed a technology transfer contract for its high-efficiency cell culture platform technology (MLSC) that can be applied as a raw material cell for gene cell therapy products. The two companies decided to not disclose the size of the contract. Under this contract, Medipost decided to hand over the license to LG Chem for product development and commercialization using related technologies such as high-efficiency mesenchymal stem cells and MLSC, a high-efficiency cell culture platform technology. LG Chem will use Medipost’s underlying technology to develop an innovative gene cell therapy pipeline that combines its gene technology.

△Korea-US technology transfer spectrum “Next year Pogiotinib, FDA application for approval”

Spectrum, a US pharmaceutical company that has transferred the technology from the US, plans to apply for an item license from the US Food and Drug Administration (FDA) next year for the new drug candidate’Pogiotinib’, a new drug candidate in Hamang. Spectrum is on the 22nd (local time). Hanmi Pharm said on the 23rd that they agreed to submit new drug marketing licenses at a preliminary meeting based on clinical results for cohort (group) 2 of HER2 exon (Exon20) mutant-positive non-small cell lung cancer (NSCLC) patients. The (objective response rate) was 27.8% and the total ORR range was 18.9~38.2% (95% confidence interval), reaching the minimum effective value (17%).

△ Jinwon Life Sciences promotes clinical trials for oral treatment for Corona 19

Jinwon Life Sciences said on the 24th that it will promote the domestic clinical development of GLS-1027, an oral treatment for COVID-19, which has been approved for phase 2 clinical trials by the US Food and Drug Administration (FDA). An official of the company said, “It is an oral low-molecular drug that suppresses cytokines, a substance that induces inflammation,” and “GLS-1027, which has the effect of preventing serious lung diseases caused by Corona 19, can be expected to play a role as a preemptive treatment.” The company is currently preparing to apply for a phase 2 clinical trial plan by the Ministry of Food and Drug Safety of GLS-1027.

△Genexine transfers the technology of’GX-P1′, an immunosuppressant, to Turret Capital in the US

Genexine announced on the 24th that it has signed a technology transfer contract for’GX-P1′, a single fusion immunosuppressant for PD-L1, with Turret Capital, a US bio-specialized investment company. With this contract, Genexine will receive 1 million shares of common stock equivalent to 5% of the total issued shares of Egret Therapeutics as a down payment. Separately, up to $200 million (200 billion won) as a sales milestone from commercialization, and up to $1.5 billion (1.7 trillion won) in the case of sub-license contracts are paid. GX-P1 is currently undergoing phase 1 clinical trials for indications such as stroke, endometriosis, and premature birth.

△JW Pharmaceutical’s’Rivaro’ expands to 31 countries with diabetes safety certification

Announced on the 22nd that the number of countries accrediting the safety of diabetes for hyperlipidemia drug Rivaro increased from 21 to 31. The additional confirmed countries are Singapore, Malaysia, Lebanon, Saudi Arabia, Bahrain, Jordan, Kuwait, Oman, Qatar, and the United Arab Emirates. With the addition of 10 countries in East Asia and the Middle East this time, a total of 31 countries can insert the phrase’no signs of diabetes risk’ in Rivaro’s Medicines Manual (SmPC).

△ICM transfers technology to LG Chem as a new drug candidate for degenerative arthritis

On the 22nd, ICM, a bio-venture specializing in gene therapy products, announced on the 22 that it has signed a contract to transfer the technology of’ICM-203′, a new drug candidate for degenerative arthritis treatment. ICM-203 is a gene therapy candidate that can be applied to a number of indications, such as the treatment of degenerative arthritis, using a non-pathogenic virus adeno-associated virus (AAV) as a vehicle. Phase 1 clinical trials in Australia and the United States are ahead.

△MedFacto promotes 100 billion won for orphan drug clinical funding

A biomarker (biomarker)-based innovative new drug development company announced on the 24th that it will issue convertible preferred stocks (CPS) and privately funded convertible bonds (CB) for the purpose of securing funds for clinical trials for approval of rare and intractable diseases of Baektoseotip, an anticancer drug candidate. . The amount of financing is about 100 billion won, with 30 billion won as convertible preferred stocks allocated to third parties and 70 billion won in convertible bonds in the form of private equity. The company plans to use the secured funds for clinical trials for approval of rare and intractable diseases.

△Alteogen, applied for IND for finished product of recombinant human hyaluronidase

It announced on the 24th that it has submitted a clinical trial protocol (IND) to the Ministry of Food and Drug Safety for approval as a finished product Tergase for new recombinant human hyaluronidase (ALT-B4) used as a pain reliever. The finished hyaluronidase product has the effect of relieving pain and swelling, so it is a product used with a filler in dermatology and plastic surgery. Previously, animal-derived hyaluronidase lyophilized injections and liquid injections have been used.