LeaderMed Health Group Ltd.

May 12 (Reuters) - Zealand Pharma (ZELA.CO) and partner Boehringer Ingelheim on Wednesday announced positive trial data for their weight-loss treatment and joined the race for a share of a global obesity drug market that is expected to touch $100 billion within a decade. More than half a dozen companies are developing weight-loss therapies similar to Novo Nordisk's (NOVOb.CO) Wegovy, with Eli Lilly and Co's (LLY.N) tirzepatide widely expected to be the next to hit the market. The following is a list of companies targeting the next big blockbuster opportunity: Novo Nordisk's (NOVOb.CO) weekly injection Wegovy was approved in 2021. It works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that triggers the feeling of fullness in the body after eating. The company also had an older product Saxenda, approved in 2014, but Wegovy is considered safer and more effective. Novo said last week it would have to halve the supply of starter doses of Wegovy in the U.S. to cope with high demand. Eli Lilly (LLY.N) said last month its diabetes treatment Mounjaro helped people with type 2 diabetes who were also obese or overweight to lose nearly 16% of their body weight in a large trial. The drug, also known as tirzepatide, is expected to receive a U.S. approval for weight loss later this year. Tirzepatide activates the body's receptors for gastric inhibitory polypeptide (GIP) and GLP-1, which are natural hormones and found in areas of the brain important for appetite regulation. Pfizer Inc (PFE.N) and Japanese partner Sosei Heptares' (4565.T) experimental oral GLP-1 drug, PF-07081532, is being tested in a mid-stage trial to treat type 2 diabetes and obesity. The company said it plans to enroll some patients in its late-stage trial who have already used Wegovy or Mounjaro to show they can effectively switch to Pfizer's oral alternative. Amgen Inc's (AMGN.O) experimental obesity drug, AMG133, showed promising durability trends in an early-stage trial late last year. The drug candidate showed mean weight loss of 14.5% after 12 weeks of treatment at the highest monthly dose. It has a dual mechanism which targets GLP-1 and GIP. The company said it plans a larger mid-stage study this year. Altimmune Inc (ALT.O) in March said its experimental obesity drug, pemvidutide , helped reduce weight by over 10% on average in a mid-stage trial. However, the drug candidate also showed safety concerns with patients experiencing nausea and vomiting of mild and moderate severity. Pemvidutide is a dual action drug that targets GLP-1 and also imitates another gut hormone called glucagon, which helps burn more fat when exercising and prevents the harmful build-up of fat in the liver. Viking Therapeutics Inc's (VKTX.O) experimental obesity drug, VK2735, showed up to 6% reduction in mean weight in an early-stage study. The company plans to test higher doses of the drug over a longer treatment window in a mid-stage trial and expects results from an early-stage extension study to evaluate oral doses by the middle of the year. VK2735 is also a dual action drug that targets both GLP-1 and GIP receptors. Denmark's Zealand Pharma (ZELA.CO) and Boehringer Ingelheim's experimental obesity treatment achieved up to 14.9% weight loss in a mid-stage trial on Wednesday. The drug candidate, BI 456906, also targets GLP-1 and GIP receptors. OPKO HEALTH Opko Health (OPK.O) has completed a mid-stage trial of its obesity drug, pegapamodutide, that it expects will have fewer side effects. The current GLP-1 drugs can cause nausea and vomiting. China's LeaderMed has agreed to develop and sell Opko's compound in the country. The company is also in talks with larger drugmakers in Western countries for a partnership. Our Standards: The Thomson Reuters Trust Principles.

MIAMI, Nov. 08, 2022 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended September 30, 2022. Business highlights for the third quarter of 2022 and subsequent weeks include the following: Pfizer’s NGENLA® (somatrogon) launched in Japan, Germany and other global markets; Pfizer seeking pricing approvals in additional European countries and continuing to work with FDA to obtain approval in the U.S. NGENLA treats pediatric patients with decreased growth due to insufficient growth hormone and reduces the injection frequency from once daily to once weekly. NGENLA is the first once weekly product approved for the treatment of pediatric growth hormone deficiency in Japan, Canada, Australia, Taiwan, UAE and Brazil. Its European Union marketing authorization is valid in all EU Member States as well as Iceland, Norway and Liechtenstein. In Australia, NGENLA is now offered through the Pharmaceutical Benefits Scheme, Australia’s national drug subsidy program. ModeX Therapeutics, Inc. (ModeX) progresses proprietary immunotherapy pipeline. ModeX continues to advance its pipeline of antiviral and immune-oncology products utilizing its next generation multispecific antibodies. In addition, ModeX is pursuing potential licensing and collaboration arrangements with strategic partners for certain of its early stage pipeline candidates. Innovation and cost cutting efforts continue at BioReference Laboratories (BRL). BRL continues significant cost reduction and business rationalization efforts following the decline of COVID testing volume. These efforts have resulted in a reduction of more than $100 million in annualized costs to date. Furthermore, BRL is exploring other revenue sources to work toward returning BRL to profitability. Third Quarter Financial Results Pharmaceuticals: Revenue in the third quarter of 2022 decreased to $32.4 million from $36.9 million in the third quarter of 2021, driven by foreign currency exchange and lower sales of RAYALDEE. During the third quarter of 2022, OPKO received gross profit share and royalty payments from Pfizer related to sales of NGENLA. We expect these payments to increase as Pfizer receives additional pricing approvals and launches the product in other geographies. Revenue from sales of RAYALDEE in the third quarter of 2022 was $6.9 million compared with $8.5 million in the prior-year period; however, we also began to receive royalty payments from sales of RAYALDEE by CSL Vifor in Germany and Switzerland during the third quarter of 2022. We expect these payments to increase as CSL Vifor launches RAYALDEE in additional territories throughout Europe. There were several significant events that positively impacted third quarter 2021 results, and should be considered when comparing those results to 2022. Revenue from the transfer of intellectual property was $4.5 million in the third quarter of 2022 compared with $8.8 million in the 2021 period. The third quarter of 2021 also included $4.9 million related to an exclusive license agreement with CAMP4 Therapeutics Corp. and $1.0 million due to the joint venture with LeaderMed Health Group Ltd. Total costs and expenses were $65.2 million in the third quarter of 2022 compared with $17.0 million in the prior-year period, which included a $31.5 million gain on the sale of OPKO’s fill-finish manufacturing facility in Ireland to Horizon Therapeutics. In addition, the increase in total costs and expenses in the third quarter of 2022 was primarily attributable to higher amortization expenses related to the reclassification of NGENLA’s in-process research and development upon its approval in Europe and Japan, higher employee expenses associated with the ModeX acquisition and higher research and development costs for somatrogon, partially offset by foreign currency exchange. The operating loss of $28.3 million in the third quarter of 2022 compared to operating income of $28.6 million in the third quarter of 2021 reflects these events. Diagnostics: Revenue from services in the third quarter of 2022 was $142.8 million compared with $340.1 million in the prior-year period, the decrease primarily due to lower COVID-19 testing volume. BRL processed approximately 0.2 million COVID-19 PCR tests in the third quarter of 2022 versus 2.2 million tests in the third quarter of 2021. Total costs and expenses were $192.3 million in the third quarter of 2022 compared with $320.5 million in the third quarter of 2021, resulting in an operating loss of $49.5 million compared with operating income of $19.7 million in the 2021 period. BRL continues to implement significant cost-reduction initiatives and scaled back digital health investments as it looks to return to profitability following the buildup and then decline of COVID-related testing. The third quarter of 2022 included $5.1 million in severance costs as the company reduced employee costs on an annualized basis by over $46 million. Consolidated: Consolidated total revenues for the third quarter of 2022 were $179.7 million compared with $385.8 million for the comparable period of 2021. Operating loss for the third quarter of 2022 was $87.8 million compared with operating income of $37.8 million for the 2021 quarter. Net loss for the third quarter of 2022 was $86.1 million, or $0.11 per share, compared with net income of $28.7 million, or $0.04 per diluted share, for the 2021 quarter. Net loss for the third quarter of 2022 included a non-cash expense of $30.6 million due to a decrease in the fair value of OPKO’s Sema4 investment, while the comparable quarter of 2021 included a $31.5 million gain on the sale of the facility in Ireland. Cash and cash equivalents: Cash and cash equivalents were $180.8 million as of September 30, 2022. Conference Call and Webcast Information OPKO’s senior management will provide a business update, discuss third quarter financial results and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call using this link. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (833) 630-0584 (U.S.) or (412) 317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here. A telephone replay will be available until November 15, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 5757952. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit . Cautionary Statement Regarding Forward Looking Statements This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, the risk of downturns and a changing regulatory landscape in the highly competitive healthcare industry, whether our products will launch in all the territories in which they have been approved for sale, the timing of such launches, the ability to get beneficial pricing approvals, whether RAYALDEE prescriptions will increase, our product development efforts and the expected benefits of our products, whether the relationship with our business partners will be successful, whether our business partners will be able to commercialize our products and successfully utilize our technologies, our ability to market and sell any of our products in development, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relationship with our commercial partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. Contacts: LHA Investor Relations Yvonne Briggs, 310-691-7100 ybriggs@lhai.com or Bruce Voss, 310-691-7100 bvoss@lhai.com —Tables to Follow— OPKO Health, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in millions) Unaudited As of September 30, 2022 December 31, 2021 Assets: Cash and cash equivalents $ 180.8 $ 134.7 Assets held for sale 0.0 315.0 Other current assets 233.2 373.3 Total current assets 414.0 823.0 In-process research and development and goodwill 768.5 1,110.8 Other assets 1,042.3 465.9 Total Assets $ 2,224.8 $ 2,399.7 Liabilities and Equity: Accounts payable $ 49.8 $ 82.0 Accrued expenses 112.0 193.5 Current portion of convertible notes 70.6 0.0 Liabilities associated with assets held for sale 0.0 28.2 Other current liabilities 34.8 26.3 Total current liabilities 267.2 330.0 Long term portion of convertible notes 141.8 187.9 Deferred tax liabilities 135.1 148.5 Other long-term liabilities, principally contract liabilities, leases, contingent consideration and lines of credit 51.6 48.2 Total Liabilities 595.7 714.6 Equity 1,629.1 1,685.1 Total Liabilities and Equity $ 2,224.8 $ 2,399.7 OPKO Health, Inc. and Subsidiaries Condensed Consolidated Statements of Operations (in millions, except share and per share data) Unaudited For the three months ended September 30, For the nine months ended September 30, 2022 2021 2022 2021 Revenues Revenue from services $ 142.8 $ 340.1 $ 616.3 $ 1,244.3 Revenue from products 32.4 36.9 104.9 106.5 Revenue from transfer of intellectual property and other 4.5 8.8 97.7 22.6 Total revenues 179.7 385.8 818.9 1,373.4 Costs and expenses Cost of revenues 148.4 244.0 586.7 900.4 Selling, general and administrative 79.7 105.1 298.7 330.6 Research and development 18.8 18.3 54.4 55.8 Contingent consideration (0.8 ) (0.5 ) (0.7 ) (1.6 ) Amortization of intangible assets 21.4 12.6 66.2 37.8 Gain on sale of assets 0.0 (31.5 ) (15.4 ) (31.5 ) Total costs and expenses 267.5 348.0 989.9 1,291.5 Operating income (loss) (87.8 ) 37.8 (171.0 ) 81.9 Other expense, net (38.6 ) (6.4 ) (118.3 ) (30.1 ) Income (loss) before income taxes and investment losses (126.4 ) 31.4 (289.3 ) 51.8 Income tax benefit (provision) 40.3 (2.7 ) 46.5 (8.0 ) Income (loss) before investment losses (86.1 ) 28.7 (242.8 ) 43.8 Loss from investments in investees (0.0 ) (0.0 ) (0.4 ) (0.2 ) Net income (loss) $ (86.1 ) $ 28.7 $ (243.2 ) $ 43.6 Income (loss) per share, basic and diluted $ (0.11 ) $ 0.04 $ (0.34 ) $ 0.07 Weighted average common shares outstanding, basic and diluted 750,396,263 651,843,074 708,121,980 646,710,240

昨日（9月5日），信达生物披露mazdutide (研发代号：IBI362，LY3305677) 在中国肥胖受试者中的II期临床研究高剂量 (9.0 mg) 队列完成首例受试者给药。Mazdutidemazdutide是一种胃泌酸调节素（OXM），是哺乳动物OXM的合成肽类似物，其脂肪酰基部分可以延长半衰期，PK特性适合每周一次给药。由于OXM是胰高血糖素样肽-1受体(GLP1R)和胰高血糖素受体(GCGR)的双重激动剂，OXM的厌食和促进能量消耗作用分别是通过激活GLP-1受体和胰高血糖素受体介导的。当外源性给药时，OXM可以改善葡萄糖耐量并导致体重减轻，使GLP-1和胰高血糖素受体双激动剂成为T2D和/或肥胖患者有希望的治疗选择。在小鼠的临床前试验中，mazdutide改善了血糖控制，降低了Gcgr敲除(KO)和Glp1r KO设置下小鼠下的体重，并增加了能量消耗。一项针对健康受试者的首次人体单剂量升高研究和一项针对中国超重和肥胖成年人的多次剂量爬坡研究表明，mazdutide具有良好的安全性和耐受性，与I期试验中的其他肠促胰岛素相似，具有一定减肥效果和多种代谢益处。而II期临床也在逐步展开。此外，值得关注的同类型竞品也在我国布局。OPK88003（TT401 ，LY2944876）OPK88003是一种胃泌酸调节素（oxyntomodulin）的类似物，每周给药，活性不均匀，最初由Transition Therapeutics和礼来联合开发，随后Transition Therapeutics被以色列公司OPKO Health, Inc.收购，OPKO公司随后获得了OPK88003的开发权。而收购之后OPKO公司自身的胃泌酸调节素候选产品MOD-6031似乎未有下文。目前，OPK88003已经在招募了420名二型糖尿病患者的II期临床试验中进行了研究。与目前批准的长效药物艾塞那肽相比，接受最高剂量OPK88003(胃泌酸调节素)每周一次的受试者表现出统计学显著的体重减轻。与艾塞那肽相似，OPK88003也降低了糖化血红蛋白(HbA1c或A1c ),糖化血红蛋白是糖代谢的标志。OPKO Health于2018年3月启动了OPK88003的2b期剂量递增临床试验研究，以优化将增加糖尿病患者体重减轻和降低HbA1c的给药方案，该研究于2019年完成。最近的给药方案研究显示，与二甲双胍相比，体重减轻(5.4千克)、HbA1c (1.4)和血脂水平均有所改善。在之前的2期研究中，与GLP-1肠促胰岛素治疗相比，OPK-88003治疗可以更显著地降低甘油三酯和总胆固醇。去年，OPKO公司宣布与领康集团（LeaderMed Group）成立合资企业，在中国和其他亚洲地区开发、生产和商业化胃泌酸调节素OPK88003和VIIa因子-CTP。根据协议条款，OPKO授予合资公司独家开发、制造和商业化OPK88003和因子VIIa-CTP(一种正在开发的用于治疗血友病的新型长效凝血因子)的权利，以换取合资公司47%的所有权。LeaderMed将负责为合资企业的运营、开发和商业化努力提供资金。OPKO保留在所有其他地区对胃泌酸调节素和VIIa因子CTP的全部权利。小编总结考虑到我国是目前世界上最大的肥胖市场，NASH，二型糖尿病等疾病伴生出现，未得到满足的肥胖药物市场具有巨大潜力。尽管许多GLP-1受体激动剂已经在国内上市，但也面临半衰期较短，给药次数不均一等临床应用问题。双激动剂的开发目前仍然需要证明比GLP-1受体激动剂的疗效，且减少相关副作用。参考来源：Tham, L. S. et al. A first-in-human single ascending dose study of oxyntomodulin analog ly3305677 in healthy subjects.Diabetes10.2337/db21-106-OR (2021).Jiang H, Pang S, Zhang Y, Yu T, Liu M, Deng H, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L, Yang W. A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes. Nat Commun. 2022 Jun 24;13(1):3613. doi: 10.1038/s41467-022-31328-x. PMID: 35750681; PMCID: PMC9232612.Pocai A. Action and therapeutic potential of oxyntomodulin. Mol Metab. 2013 Dec 14;3(3):241-51. doi: 10.1016/j.molmet.2013.12.001. PMID: 24749050; PMCID: PMC3986661.近期热门视频更多精彩视频，尽在佰傲谷视频号，欢迎关注~本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀ 点亮在看，传递信息♥