According to multiple sources in the industry, from October 16 to 18, the National Medical Insurance Administration conducted pre-negotiations with companies that passed expert reviews. As in last year, “pre-negotiations” give companies ample opportunities for communication. Before the formal negotiations, the National Medical Insurance Administration specially organized experts and companies that intend to participate in the negotiations to fully communicate around the payment standard calculations for the intended negotiated products. The medical insurance party and the enterprise party first go through a round of “pre-negotiations” before the formal negotiations, which can facilitate the enterprise party to more fully understand the negotiation rules, and when the formal negotiations are held, the results will be relatively ideal. Previously, the National Medical Insurance Administration had organized fund calculations and pharmacoeconomic calculations in Xiaotangshan, Beijing. On September 19, the National Medical Insurance Administration held an on-site communication meeting for companies to negotiate/bid in Beijing. ...
P-glycoprotein (P-gp) belongs to the ATP Binding Cassette (ABC) protein family and is an ATP dependent transmembrane efflux transporter. It is mainly encoded by the multidrug resistance gene (MDR1), also known as ABCB1 gene, in the human body. P-gp is related to multidrug resistance and drug drug interactions (DDIs). Drug regulatory authorities in the United States, Europe, and China have successively issued guidance principles, listing transporter mediated DDI research as an important indicator for evaluating the safety and efficacy of new drugs. It is also explicitly stated that in vitro studies should be conducted to evaluate whether the investigational drug is a substrate, inhibitor, or inducer of P-gp, providing reference for in vivo studies. Based on the above requirements, IPHASE/Huizhi and Yuanji have successfully constructed SLC transporter cells, including OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, and MATE2-K. In addition, they have also successfully constructed the first P-gp transporter membrane vesicle ...
Original Time Biopharmaceutical Editor October 14, 2024 09:20 Shanghai The weight loss drug concept stock Zealand has suffered another setback, as its new drug Dasiglucagon, which was launched to treat congenital hyperinsulinemia (CHI) in children, has once again been rejected by the FDA. Last December, Dasiglucagon was rejected by the FDA for the first time due to the discovery of defects in a third-party contract manufacturing factory. Zealand pointed out that the main reason for Dasiglucagon’s second rejection was that the FDA failed to complete the re inspection of third-party production factories, resulting in the approval process being put on hold. The FDA did not raise any concerns about the effectiveness or safety of Dasiglucagon. Dasiglucagon is a glucagon receptor (GCGR) agonist that acts to release stored glycogen from the liver into the bloodstream. Hypoglycemia is one of the most common acute complications of diabetes, and patients who have the ...
Recently, InnoCare announced that the Phase II clinical study of ICP-488, a novel self-developed tyrosine kinase 2 (TYK2) inhibitor, in the treatment of moderate to severe plaque psoriasis, met the primary endpoint. In patients treated for 12 weeks, ICP-488 demonstrated superior efficacy and safety. ICP-488 met multiple efficacy endpoints in the once-in-a-day 6 mg and once-daily 9 mg dose groups, including Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100 (PASI score improvement from baseline ≥75%, ≥90%, and ≥100%), and static Clinician’s Global Assessment (sPGA) 0/1 (i.e., complete or basic clearance of lesions). The response rate of PASI 75 was 77.3% and 78.6%, respectively, in the once-daily 6 mg and 9 mg dose groups, compared with 11.6% in the placebo group (p<0.0001). The response rate of PASI 90 in the two dose groups reached 36.4% and 50.0%, respectively, compared with 0% in the placebo group (p<0.0001); The response ...
Source: 21st Century Business Herald Has the cow arrived? The A-share market is booming, don’t miss the opportunity, open an account and layout now>> Recently, there has been a frequent wave of business development (BD) cooperation transactions between Chinese and foreign pharmaceutical companies. On October 9th, Baiaotai announced that it has reached an authorization license, production, supply, and commercialization agreement with Gedeon Richter Plc. for BAT2206 (ustekinumab) injection solution. According to the agreement, Baiaotai will license the exclusive commercial rights of the injection in the EU, UK, Switzerland, Australia, and other European markets to Gedeon Richter Plc for a fee. The amount involved in this transaction includes a down payment of $8.5 million, milestone payments up to a cumulative total of $101.5 million, and revenue sharing based on a double-digit percentage of net sales. In addition to Baiaotai, several Chinese pharmaceutical companies have also recently received positive news regarding BD ...
October 11, 2024 09:03 Source: 21st Century Business Herald Has the cow arrived? The A-share market is booming, don’t miss the opportunity, open an account and layout now>> Recently, there has been a frequent wave of business development (BD) cooperation transactions between Chinese and foreign pharmaceutical companies. On October 9th, Baiaotai announced that it has reached an authorization license, production, supply, and commercialization agreement with Gedeon Richter Plc. for BAT2206 (ustekinumab) injection solution. According to the agreement, Baiaotai will license the exclusive commercial rights of the injection in the EU, UK, Switzerland, Australia, and other European markets to Gedeon Richter Plc for a fee. The amount involved in this transaction includes a down payment of $8.5 million, milestone payments up to a cumulative total of $101.5 million, and revenue sharing based on a double-digit percentage of net sales. In addition to Baiaotai, several Chinese pharmaceutical companies have also recently received ...
On August 5, Hong Kong-listed innovative pharmaceutical company Jiahe Biologics (06998.HK) announced that the group entered into a licensing agreement and equity agreement with TRC2004, Inc. on August 2. Pursuant to the License Agreement, the Group has agreed, among other things, to grant TRC2004 an exclusive global license (excluding Mainland China, Hong Kong, Macau and Taiwan) to develop, use, manufacture, commercialize and otherwise exploit GB261. According to the terms of the license agreement and equity agreement, as consideration for the license, the Group will receive a considerable amount of equity in TRC2004, an down payment of tens of millions of US dollars, milestone payments of up to US$443 million, and a single-digit to double-digit share of net sales. percentage tiered royalties. CD3/CD20 inhibitor potential stocks. GB261 is a new type of differentiated CD20/CD3 bispecific T cell engager (TCE) and the first T cell engager (T-cell Engager) that binds to CD3 ...
ARCH Venture Partners, an American biotech investment institution, announced the completion of over $3 billion in ARCH Venture Fund XIII fundraising, aimed at supporting the establishment and development of early-stage biotech companies. The 13th fund was established following the 12th fund of $2.975 billion announced in June 2022. “After 38 years, ARCH’s investment philosophy remains the same: we bet on great science and great teams to build breakthrough companies,” said Robert Nelsen, co-founder and managing director of ARCH. “We believe that artificial intelligence and new data-driven insights into biology will help build a more preventive, curative and equitable healthcare system.” “ARCH has a long history of identifying the top forward-looking trends in life science R&D and individuals who drive truly groundbreaking scientific hypotheses,” said Keith Crandell, co-founder and managing director of ARCH. “We are very excited about the pace of innovation and efforts to understand diseases at a deeper level.” ...
On October 7, AstraZeneca and CSPC Pharmaceutical Group signed an exclusive licensing agreement, and AstraZeneca will obtain CSPC Pharmaceutical Group’s preclinical candidate small molecule drug YS2302018. The transaction amount hit a new high. According to the agreement, CSPC Pharmaceutical Group will receive an advance payment of US$100 million and is entitled to receive potential development milestone payments of up to US$370 million and potential sales milestone payments of up to US$1.55 billion, as well as tiered sales commissions calculated based on the annual net sales of the product (the total transaction amount exceeds RMB 10 billion at the current exchange rate). YS2302018 is a preclinical innovative small molecule lipoprotein (a) (Lp(a)) inhibitor used to develop new lipid-lowering therapies, as well as monotherapy or combination therapy for a variety of cardiovascular diseases, including in combination with the oral small molecule PCSK9 inhibitor AZD0780. Lpa is an important target in the field ...
Recently, well-known industry media Endpoint News released the “Biopharma’s Most Exciting Startups in 2024” list, which includes 11 biotechnology companies. These emerging research fields include gene editing, immunotherapy, antibody conjugated drugs (ADCs), weight loss therapy, and multiple other directions. This article will introduce these 11 rising stars (listed in no particular order) to readers, based on this ranking and official information from various companies. Lifordi Immunotherapies is a biotechnology company dedicated to developing ADC therapies for the treatment of autoimmune and inflammatory diseases. Lifordi was founded in 2023 and has secured $70 million in Series A funding from ARCH Venture Partners, 5AM Ventures, and Atlas Venture, with the goal of advancing the main candidate drug LFD-200 into clinical trials and obtaining preliminary data by the end of 2025. Lifordi’s main ADC therapy LFD-200 targets myeloid cells and lymphocytes by targeting highly internalized cell surface facial mask proteins. This therapy has ...
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