InflaRx will provide access to specific clinical, manufacturing and regulatory documents for vilobelimab to facilitate regulatory submission of STS in China.
STS plans to apply for regulatory approval in China for its proprietary anti-C5a antibody BDB-001 for the treatment of COVID-19, based on STS-licensed InflaRx technology.
InflaRx to receive 10% royalty on net sales of BDB-001 for treatment of COVID-19 in China
STS makes an additional $2.5 million investment in InflaRx at a price of $5.00 per share
InflaRx makes an additional US$7.5 million investment in InflaRx with option to request STS
JENA, Germany, December 21, 2022 (GLOBE NEWSWIRE) — InflaRx NV (Nasdaq: IFRX) (the “Company” or “InflaRx”) is a clinical-stage company developing anti-inflammatory therapeutics that target the complement system. A biopharmaceutical company. Today, the Company amended its existing co-development agreement with Staidson (Beijing) BioPharmaceuticals Co., Ltd. (together with its affiliates, “STS”) to announce that STS is in the process of seeking regulatory approval of its proprietary drug candidate BDB-001. announced to support in China. Under an amendment to an existing co-development agreement, InflaRx will receive a 10% royalty on net sales of his BDB-001 for the treatment of his COVID-19 in China. InflaRx has reviewed his InflaRx clinical, manufacturing, and regulatory documentation for vilobelimab to support and expedite the regulatory filing of BDB-001 for the treatment of Chinese patients with critically ill COVID-19. We have granted STS an exclusive license for use in part in China. Medical Products Administration (NMPA).
Under an existing co-development agreement, BDB-001, an anti-C5a antibody derived from the same cell line as viloberimab, is being developed by STS for the treatment of severe COVID-19 and other inflammatory diseases in China. increase. The existing joint development agreement includes an exclusive license limited to development and commercialization within China and was granted to STS by InflaRx in 2015. STS now plans to apply for regulatory approval in China for he BDB-001 for the treatment of COVID. -19.
In connection with the amendment to the joint development agreement, InflaRx also announced today that it has entered into a share purchase agreement with Staidson Hong Kong Investment Company Limited, an affiliate of Staidson (Beijing) BioPharmaceuticals Co., Ltd. He will purchase additional shares of InflaRx common stock at a price of US$5.00 per share for a total of US$2.5 million. The Stock Purchase Agreement also includes an option for STS to purchase additional common stock for an aggregate amount of US$7.5 million at his InflaRx discretion. Such subsequent purchase options will expire on the 12-month anniversary of STS obtaining regulatory approval of BDB-001 in China. Any such subsequent investment will be made at the higher of US$5.00 per share or a 20% premium to the weighted average share price for the fifteen (15) trading days preceding the closing date of such subsequent investment.
“Given the recent sharp increase in COVID-19 cases in China and the potential benefits of our anti-C5a technology, STS is pleased to advance BDB-001 for the treatment of COVID-19 in China. Professor Niels C. Riedemann, CEO and Founder of InflaRx, said: “In addition, STS’s investment in InflaRx will allow us to launch several of our proprietary vilobelimab products. We will further strengthen our near-term and long-term financial position as we move forward in the indications of
InflaRx’s first-in-class monoclonal anti-human complement factor C5a antibody, vilobelimab, has been approved by the U.S. Food and Drug Administration for Emergency Use Authorization for the treatment of critically ill, intubated, ventilator-bound COVID-19 patients. Submitted to the Drug Administration (FDA). InflaRx retains all rights to vilobelimab. Biroberimab is also in clinical development for the treatment of various indications such as pyoderma gangrenosum and cutaneous squamous cell carcinoma.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any common stock or other securities, nor does any such offer, solicitation or otherwise violate the securities laws of any state or other jurisdiction. It is illegal to sell before registration or qualification under
About InflaRx NV:
InflaRx (Nasdaq: IFRX) will apply its proprietary anti-C5a and C5aR technologies to discover and develop potent and specific first-in-class or best-in-class inhibitors of known complement activators A focused clinical-stage biopharmaceutical company. As its receptors known as C5a and C5aR. Complement C5a and its receptor C5aR are potent inflammatory mediators involved in the progression of various autoimmune and other inflammatory diseases. InflaRx was founded in his 2007 and the group has offices and subsidiaries in Jena and Munich, Germany, and Ann Arbor, Michigan, USA. For more information, please visit www.inflarx.de.
COVID-19-related research on vilobelimab was funded in part by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work rests with his InflaRx.
About Staidson (Beijing) Biopharmaceuticals Co., Ltd.:
STS (SZSE: 300204) is an innovative biopharmaceutical company specializing in the research and development, manufacturing and marketing of pharmaceuticals. STS is a high-tech enterprise with a complete system of R&D, production and marketing. STS was founded in 2002 and listed on the Shenzhen Stock Exchange in 2011. STS is engaged in the research, development, manufacturing and marketing of therapeutics with unmet clinical need, including protein medicines (including therapeutic monoclonal antibody medicines) and gene/cell therapies. drugs and chemicals.
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This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements and often include statements such as “may,” “will,” “should,” “expect,” “plan.” ”, “expect”, “may”, etc. “intend,” “target,” “plan,” “believe,” “estimate,” “predict,” “could,” or “continue,” and similar expressions. Forward-looking statements appear in many places throughout this release and include, among other things, statements regarding our (or STS, as the case may be) intentions, beliefs, projections, prospects, analyses, and current expectations regarding: There are cases. Expectations regarding the impact of the joint development agreement and potential additional investments under the investment agreement. our (or STS, as the case may be) ongoing and planned preclinical development and clinical trials; exchange. The impact of the COVID-19 pandemic on your company. Timing and ability to initiate and conduct clinical trials. potential outcomes from current or potential future collaborations; the ability to submit regulatory applications, obtain active guidance from regulatory authorities, and obtain and maintain regulatory approval for product candidates; the location of that intellectual property; Ability to develop commercial capabilities. expectations regarding clinical trial data; decisions regarding our strategic direction; operating results, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategy; the industries in which we operate; trends that may affect the industry or our business; Risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and our actual results, performance or achievements, either expressed or implied. It involves other important factors that could cause future results, performance or achievements to differ materially. By forward-looking statements. Given these risks, uncertainties and other factors, undue reliance should not be placed on these forward-looking statements. law.