Oregovomab

Recently, the United States has announced the first 10 drug prices after negotiations under the Inflation Reduction Act (IRA). Among these drugs, the price reduction for at least 9 of them is at least 50%. Among them, the reduction in the price of diabetes treatment drugs is particularly significant: Merck's Januvia price was reduced by 79%, from $527 per month to $113; Novo Nordisk's Fiasp, a treatment drug for type 1 diabetes, was reduced by 76%, from $495 per month to $119; AstraZeneca's Farxiga (dapagliflozin) was reduced by 68%. The First List of Drug Prices Negotiated under the US IRA Act Drug Name Original Price (Monthly) Negotiated Price (Monthly) Reduction Rate Januvia 527 113 0.79 Fiasp 495 119 0.76 Farxiga (Dapagliflozin) - - 0.68   According to a research report, the implementation of the first round of drug negotiations under the US IRA Act has resulted in price reductions ranging from 38% to 79% for the covered drugs. However, due to the fact that these drugs generally have a high list price and high rebate business model, it is expected that the negotiated price reduction will have a net impact on the actual product price of around 10% to 20%. Currently, these negotiated prices only apply to Medicare patients and not to patients with commercial insurance, thus having a limited short-term financial impact on the originator pharmaceutical companies.   From a long-term perspective, the IRA negotiated price reduction may lead to a shorter peak return period for individual products, prompting pharmaceutical companies to be more inclined to develop drugs with broad indications as their initial indications. Considering the long R&D cycle, in the case of a shortened peak return period, large pharmaceutical companies may accelerate their acquisition and merger activities. Based on this, the research report maintains its "outperform" rating for the domestic innovative pharmaceutical industry and recommends actively following companies that have overseas commercialization or licensing potential.   Analysis of the Impact of the First Round of Drug Negotiations under the US IRA Act Reduction in Drug Prices Impact of Net Price for Actual Products Target User Short-Term Financial Impact 38%-79% 10%-20% Medicare Patient Limited   In fact, in recent years, the internationalization process of China's innovative drugs has been accelerating. For example, on August 9, Merck & Co., a multinational pharmaceutical company, announced that it plans to acquire CN201, a dual antibody drug in development by Tongrun Biotech, for up to $1.3 billion in total transaction value, which is intended for the treatment of cancer and autoimmune diseases.   On June 14, Yasen Pharmaceuticals announced that it will license Orebactin (trade name: Nerivac) to Takeda, according to the agreement, Yasen Pharmaceuticals will receive a $100 million option payment, and is eligible to receive up to $1.2 billion in option exercise fees and additional potential milestone payments, as well as double-digit percentage royalties based on annual sales. According to industry statistics, in 2023, a total of 156 drugs were licensed out overseas, with a total transaction value of $35 billion, of which 78 projects belong to domestic enterprises going global.   Entering 2024, the number of outbound licensing transactions is still growing. Just in the first half of this year, the pharmaceutical industry has seen more than 30 outbound License-out authorizations, involving small molecules, monoclonal antibodies, and other categories. On the commercialization front, by the end of 2023, a total of six innovative drugs developed in China had been approved for the US market, and the number of approvals has shown an upward trend, with the number of approvals from 2019 to 2023 being 1, 2, and 3.   The Process of China's Innovative Pharmaceuticals Industry Going Global and Its Collaboration Event Involved Companies Transaction Amount Remarks Merck Acquires Tongrun Bio's Bispecific Antibody New Drug CN201 Merck, Tongrun Bio $1.3 Billion For the treatment of cancer and autoimmune diseases Ascentage Pharma Licenses Oregovomab to Takeda Ascentage Pharma, Takeda Up to $1.3 Billion Includes option payments, royalties and milestone payments Outbound Licensing of Chinese Drugs Domestic Companies $35 Billion 2023 data, 78 projects are outbound projects of domestic companies Innovative Drugs Listed in the US Market by China - - Number of approvals from 2019 to 2023 is 1, 2, 3 respectively   The report indicates that collaborating to expand overseas markets is an ideal choice for Chinese pharmaceutical companies. For the internationalization of innovative drugs, the following factors should be given priority: the potential peak sales of the drug, innovative drugs with a larger number of patients in the target indications are likely to have higher peak sales; drugs with a smaller patient base even if approved, the elasticity of performance and market capitalization is relatively limited; the clinical efficacy and the order of marketing authorization, drugs with the potential of being the best-in-class or me-better are expected to capture a higher market share, and drugs with earlier marketing authorization have certain first-mover advantages; the strength of overseas partners, considering that the dominant force in global innovative drug commercialization is still traditional pharmaceutical giants, drugs licensed to these leading companies are expected to have higher peak sales. Companies worth paying attention to include Yifan Pharmaceutical, Maiwei Biotech, and Hengrui Pharmaceutical.

Quest PharmaTech announced that a pivotal study of CanariaBio’s oregovomab in front-line ovarian cancer failed to hit its ​​progression-free survival (PFS) goal at an interim futility analysis. The Phase III FLORA-5 trial is investigating oregovomab with a standard six-cycle chemotherapy regimen in 615 newly diagnosed patients with advanced epithelial ovarian, fallopian tube or peritoneal carcinoma, focusing on both adjuvant and neoadjuvant cohorts. Along with the primary endpoint of PFS in the two cohorts, secondary goals include overall survival (OS).Hopes pinned on OSQuest noted that while the data safety monitoring board recommended that the study be halted, follow-up should continue as “there is a possibility of significant efficacy” in OS. The company added that it is in talks with the trial’s sponsor, CanariaBio, around continued support of the clinical programme for the CA-125-directed monoclonal antibody.CanariaBio gained oregovomab after OncoQuest, in which Quest holds a 42.5% stake, sold rights to another Korean-based company.The decision to stop the study is likely to put a dampener on CanariaBio’s global plans for oregovomab, including a string of recent licensing deals to market the drug in Australia, New Zealand, and select Southeast Asian countries with Specialised Therapeutics, and in the Middle East and North Africa region with Hikma Pharmaceuticals.