▲Andong L House, a vaccine plant in SK Biosciences (Photo courtesy of SK Biosciences)

◇Samsung Bioepis, Brazil ‘Ontruzant’ Sale = Samsung Bioepis announced on October 10 that it has launched the sale of the breast cancer drug Ontruzant in Brazil, the largest pharmaceutical market in Latin America. The Productive Development Partnership (PDP) agreement with the Brazilian Ministry of Health is a partnership with local pharmaceutical companies and state-owned research institutes to sell products. Trastuzumab’s biosimilar products were the first to enter the Brazilian government-led public market through a PDP contract.

Currently, the number of breast cancer patients in Brazil is about 67,000, an increasing trend every year. Until now, the only trastozumab-containing medicine supplied with PDP in Brazil was herceptin, the original drug. The total trastozumab ingredient drug market in the public market sector is estimated to be around 100 billion won.

◇Itc Reveals Preliminary Ruling on Nabota Dispute = U.S. International Trade Commission (ITC) has released a preliminary ruling on meditox and Daewoong Pharmaceuticals disputes over the source of botulinum toxin strains. Meditox said in a preliminary ruling that Daewoong Pharmaceutical sought to develop “Nabota” by stealing meditox botulinum strains and manufacturing processes, resulting in a 10-year import ban. In the decision, the ITC magistrate judge determined that the strain of Meditox and the strain of Daewoong Pharmaceuticals shared six unique SNP (single base polymorphism) characteristic DNA fingerprints, this fact supports the conclusion that the strain used by Daewoong Pharmaceuticals is obtained from a strain of Meditox.

In this regard, Daewoong Pharmaceutical argued that “preliminary judgments are the extremes of bias and distortion,” and that “ITC administrative judges made unfair and biased decisions that were far from substantive truths, on the side of Ellergan, for the protection of U.S. industry.” Daewoong Pharmaceutical submitted an appeal to the ITC last month.

◇Samsung Biologics announced on November 11 that it will build the world’s largest biopharmaceutical manufacturing plant based on a single plant in Songdo, Incheon. The fourth plant, which can produce 256,000 liters, has an area of approximately 240,000 square meters and is 1.5 times the size of the Sangam World Cup stadium. When completed, the 620,000 liter production base will be completed in the Songdo First Complex of Samsung Biologics, which occupies approximately 30% of the global consignment production (CMO) market. 1.74 trillion won will be invested.

The company will begin groundbreaking in the second half of this year and begin partial production at the end of 2022. In addition, we are in consultation with the Incheon Economic Free Zone Agency to secure an additional 100,000 square meters of land in Songdo, Incheon, for the construction of songdo second complex and open innovation R&D center.

◇Celltrion, Corona 19 Diagnostic Kit 2 U.S. Launch = Celltrion launched corona 19 diagnostic kit product developed in collaboration with domestic diagnostic kit specialists on the U.S. market from 12 th. In cooperation with BBB, a diagnostic device company, its own Corona 19 antibody- develops “Sampinute”, an antigen POCT product that incorporates antigen technology, and sells it locally after an emergency application from the U.S. Food and Drug Administration (FDA). Corona 19 antibody rapid diagnostic kit (RDT) DiaTrust (DiaTrust) developed with diagnostic kit specialist Humasis also applied for FDA emergency use approval and begins sales in the United States.

Celltrion believes that antibody RDT can play a complementary role with antigen POCT, and plans to actively promote the sale of diatrust in the form of a package bundled with Sampinet to maximize product ability. Currently, in cooperation with humasis to develop improved antibodies RDT and antigen RDT of higher sensitivity.

◇Non-preservation, non-narcotic analgesic u.S. clinical phase 3 discontinuation = Non-preservation of new drug development bio-drug companies specializing in pain and central nervous system diseases announced on 13 March that it will discontinue the U.S. clinical phase 3b of thumb gun film for the non-narcotic analgesic “OPIANGERIN” (VVZ-149). Corona19’s rapid re-proliferation across the United States has dramatically reduced the number of patients available for recruitment, making this decision in terms of risk management. If the patient registration schedule is delayed and slow clinical progress is slow, as well as the quality of the clinical data will suffer a significant loss in terms of cost to the clinical progress, because it can cause problems in the safety of clinical participants.

The Company plans to focus the company’s capabilities on the period during which clinical phase 3 is discontinued in the United States, such as △Technology transfer acceleration △Opirangerin injection syringe domestic clinical phase 3 progress △Clinical pharmacopoeia trial progress △Neuropathic pain drug VVZ-2471.

◇SK Biosciences, NovaBacks Corona 19 Vaccine Consignment Development and Production = SK Biosciences signed a contract with U.S. biotechnology company NovaBacks and Corona 19 vaccine candidate NVX-CoV2373 to develop and produce antigens, as well as a contract for consignment development and production (CDMO) with global supply, including Korea. The CDMO agreement aims to produce and supply the antigen manufacturing technology of Corona 19 vaccine candidate NVX-CoV2373 globally from SK Biosciences to develop additional processes and then produce it at The Andong Vaccine Plant L House.

NVX-CoV2373 is a vaccine candidate made in the form of nanoparticles after expressing the corona 19 spike protein transformed into a recombinant technology in insect cells. We are currently planning to enter phase 3 in October as soon as we reach phase 2 clinical. SK Biosciences with synthetic antigen technology and cell culture production method applied to NVX-CoV2373 at the same time, according to the contract, the process development and raw liquid production of NVX-CoV2373 at the vaccine plant L house in Andong, North Gyeonggi province from this month.

◇High BioLab, Microbioohme psoriasis treatment clinical phase 2 FDA approval = GobioLab has received final approval from the U.S. FDA for clinical phase 2 trial plan (IND) of “KBLP-001” which is being developed as a microbiome-based psoriasis treatment, it said on 14 Th. The trial will be conducted in the United States and Australia for the purpose of exploring the safety and effectiveness of KBLP-001 and the appropriate dosage of the drug for patients with moderate psoriasis.

KBLP-001 is a pipeline that is developing new drugs for the treatment of immune skin diseases has been confirmed to alleviate skin immune hypersensitivity in cell experiments and experimental animal models. GobioLab completed the clinical trial earlier this year, after receiving a clinical phase 1 trial in Australia in September and starting dosing in October of that year. Through this, it has yielded excellent results in safety and totheability evaluation.

◇Celltrion, September Prolia Biosimilar Clinical Phase 1 Initiation = Celltrion announced on 14 July that it is launching the biosimilar “CT-P41” clinical phase 1 of the osteoporosis drug “Prolia” (sungclear denosumap). The company plans to begin clinical phase 1 in September and enter phase 3 of ct-P41 in the first half of next year, preparing to commercialize it in February 2025 when Prolia’s U.S. patent for the substance expires.

Prolia is used as an antibody biopharmaceutical of amgen, a multinational pharmaceutical company, as a bone loss treatment for osteoporosis and cancer patients. Amgen’s 2019 business results showed sales of KRW 3.2trillion.

◇Daewoong Pharmaceutical ‘PexuPrazan’ enters Brazil = Daewoong Pharmaceutical announced on 14 July that it has signed an export agreement with Ems (EMS), brazil’s no.1 pharmaceutical company, for the treatment of gastroesophageal reflux disease. The size of the export contract is approximately US$73 million (approximately KRW 86 billion), including technical fees. In addition to the Mexican contract at the beginning of the year, Daewoong Pharmaceutical struck a $123 million contract with PexuPrazan in Central and South America alone.

Daewoong Pharmaceutical plans to quickly expand its market share in Brazil by combining product competitiveness with brazil’s best sales, development and marketing capabilities. P-CAB (Potassium-Competitive Acid Blocker) formulation having a mechanism to reversibably block the proton pump secreting gastric acid from the stomach wall, as a new drug for gastroesophageal reflux disease developed by Daewoong Pharmaceutical itself.



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