ChinaBio® Today http://www.aprdic.com ChinaBio® Today is the most widely-read source for China life science news and analysis. From our offices in Shanghai and California, we provide daily news, commentary and analysis on public and private China life science companies and industry events, as well as global issues affecting the China life science industry. China to Ban Export of Cutting-Edge Cell Technologies http://www.aprdic.com/articles/china-bans-cell-tech <p>China is planning to prohibit any export from biotech companies engaged in certain cutting-edge sectors -- cell cloning and gene editing technology for human use along with restrictions on the export of CRISPR gene editing technology and synthetic biology technology. Officially, the ban is in limbo during a public comment phase, though the edict will probably not change significantly. The proposed China export ban follows the 2022 US law that supported semiconductor chip manufacturing in the US and restricted export of the most powerful chips to China. More details....<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-07T11:56:00-00:00 Results from InnoCare’s BTK Lymphoma Trial Published in Hematology Journal http://www.aprdic.com/articles/results-innocares-btk <p>Beijing InnoCare&nbsp; reported the American Journal of Hematology published very positive results from a Phase II trial of its BTK inhibitor orelabrutinib. The China study enrolled 80 patients with relapsed/refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. The overall response rate was 92.5% and the complete response was 21.3%. Orelabrutinib was approved in China for three lymphoma/leukemia indications in 2020. One year ago, InnoCare out-licensed the ex-China rights for use of the drug as a MS therapy to Biogen in a deal with potential value of $937 million. More details....</p> <p>Stock Symbols:&nbsp;(HK: 09969; SHA: 688428)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-07T11:43:00-00:00 Zhimeng Biopharma Out-Licenses TLR8 Agonist, an HBV Therapy, to GSK http://www.aprdic.com/articles/zhimeng-out-licenses-gsk <p>Shanghai Zhimeng Biopharma signed an agreement to out-license global rights for its TLR8 agonist to GlaxoSmithKline as an HBV treatment. Zhimeng is currently conducting a US Phase I trial of CB06, and GSK will acquire the rights &ndash; including development, manufacturing and commercialization -- if the candidate posts successful results. CB06 is a potential candidate for combination with GSK&rsquo;s bepirovirsen, an antisense oligonucleotide that targets all HBV messenger RNAs to decrease virus load. GSK hopes to offer a virtual cure for HBV.&nbsp;The financial details of the agreement were not disclosed. More details....<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-06T14:13:00-00:00 JiXing Buys Global Rights for Hypertension Candidate from PhaseBio http://www.aprdic.com/articles/ji-xing-hypertension-phasebio <p>Shanghai JiXing Pharma bought global rights to a preclinical hypertension asset from PhaseBio Pharmaceuticals, a Philadelphia area company currently in bankruptcy. PB6440 is a next-gen selective aldosterone synthase inhibitor. In preclinical tests, the candidate inhibited aldosterone synthase but did not interfere with a homologous enzyme that is key to cortisol synthesis. JiXing brings novel drugs to China patients who have serious unmet medical needs. Terms of the agreement were not disclosed. More details....<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-06T14:02:00-00:00 Week in Review: Structure Stages $161 Million US IPO for AI/Structure-based Drug Development http://www.aprdic.com/articles/wir-structure-161-million-ipo <p><b><i>Deals and Financings</i></b></p> <ul> <li>Structure Therapeutics, a Shanghai-San Francisco company, completed a $161 million NASDAQ IPO to apply AI/structure technology to develop oral small molecule candidates for chronic metabolic and pulmonary diseases;</li> <li>CS Pharmaceuticals of London entered a $336 million agreement with South Korea&rsquo;s Daewoong for China rights to an Idiopathic Pulmonary Fibrosis therapy;</li> <li>NeuShen Therapeutics, a Shanghai-Boston CNS biotech, formed a three-year Research Agreement with UMass Chan Medical School to develop a gene therapy for ALS;</li> <li>Shanghai CARsgen formed a collaboration to test a combination of its Claudin18.2 mAb and Roche&rsquo;s PD-L1 checkpoint inhibitor in gastric cancer patients;</li> <li>Hangzhou AnHeart will use two assays developed by Palo Alto&rsquo;s Guardant Health as companion diagnostics to its ROS1 inhibitor;</li> </ul> <p><b><i>Trials and Approvals</i></b></p> <ul> <li>Wuhan&rsquo;s Nervtex announced China approval of its AI system that analyzes motor symptoms for clinical decision support of Parkinson's disease patients;</li> <li>Beijing Help Therapeutics was approved to start China clinical trials of a universal allogeneic iPS cell-derived cardiomyocyte therapy for ischemic heart failure;</li> <li>Gracell Biotech, a Shanghai cell therapy company, was approved to start a US Phase Ib/II trial of its lead candidate in relapsed/refractory multiple myeloma;</li> <li>HuidaGene Therapeutics of Shanghai and New Jersey was cleared to start a US Phase I trial of a CRISPR-based medicine for patients with inherited retinal dystrophies.</li> </ul> <p>Stock Symbols: (NSDQ: GPCR) (HK: 2171) (NSDQ: GH) (NSDQ: GRCL)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-04T10:42:00-00:00 Structure Stages Expanded $161 Million IPO for Novel Small Molecules http://www.aprdic.com/articles/structure-161-million-ipo <p>Structure Therapeutics raised $161 million in a successful US IPO to support development of its oral therapeutics portfolio aimed at chronic metabolic and pulmonary diseases. The company, formerly known as ShouTi, uses advanced computational and structure-based technology for R&amp;D of its products, which are designed to overcome limitations of current biologic and peptide drugs. Schr&ouml;dinger, a&nbsp;New York City&nbsp;company that uses advanced molecule simulations to discover drugs, is a co-founder of Structure. The IPO priced at the top of its range and traded 73% higher. Structure is based in Shanghai and San Francisco. More details....</p> <p>Stock Symbol:&nbsp;(NSDQ: GPCR)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-03T10:58:00-00:00 Gracell Biotech to Start US Trial of Dual-Targeting CAR-T Therapy for Myeloma http://www.aprdic.com/articles/gracell-trial-car-t <p>Gracell Biotech, a Shanghai cell therapy company, was approved to start a US Phase Ib/II trial of its lead candidate in patients with relapsed/refractory multiple myeloma (RRMM). GC012F is an autologous CAR-T therapeutic candidate that targets B cell maturation antigen (BCMA) and CD19. It is produced on Gracell's proprietary FasTCAR next-day manufacturing platform. In long-term investigator-initiated studies, GC012F showed a 100% minimal residual disease (MRD) negativity rate in all RRMM patients. More details....</p> <p>Stock Symbol:&nbsp;(NSDQ: GRCL)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-03T10:50:00-00:00 AnHeart to Use Guardant’s Assays for NSCLC Trials of ROS1 Inhibitor http://www.aprdic.com/articles/anheart-use-guardants-assays-nsclc-trials-ros1 <p>Hangzhou AnHeart Therapeutics, a precision medicine company, formed a collaboration to use two assays developed by Palo Alto&rsquo;s Guardant Health as companion diagnostics to its ROS1 inhibitor. AnHeart is conducting a global Phase II trial of taletrectinib in the US and EU. The trial is aimed at non-small cell lung cancer patients who are ROS1 positive &ndash; about 2% of the NSCLC population. Patients will be screened by Guardant360&reg;&nbsp;CDx, an approved circulating blood DNA test, and the tissue-based Guardant360&nbsp;TissueNext&trade; assay. In mid-2021, AnHeart out-licensed China rights for the ROS1 candidate to Innovent for $189 million in upfront and milestone payments. More details....</p> <p>Stock Symbol:&nbsp;(NSDQ: GH)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-02T10:43:00-00:00 NeuShen and UMass Partner To Develop Gene Therapy for ALS http://www.aprdic.com/articles/neushen-umass-als <p>NeuShen Therapeutics, a Shanghai-Boston CNS biotech, announced a three-year Sponsored Research Agreement with UMass Chan Medical School to develop a gene therapy for amyotrophic lateral sclerosis (ALS). NeuShen is developing CNS therapies using its dual AAV-based gene and small molecule platforms. The program will be under the direction of Dr. Guangping Gao, PhD, a well-known gene therapy researcher who has played an important role in discovering and characterizing a new family of adeno-associated virus (AAV) serotypes, which has advanced gene therapy research for currently untreatable human diseases. More details....<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-01T11:21:00-00:00 Nervtex AI Device Approved in China to Diagnose Parkinson’s http://www.aprdic.com/articles/nervtex-ai-parkinsons <p>Wuhan&rsquo;s Nervtex announced China approval of its artificial intelligence-based system that analyzes the motor symptoms of Parkinson's disease. The MoDAS (Movement Dysfunction Assessment Software) device is a First-in-Class product. Using a smart phone to record a patient&rsquo;s movement, the MoDAS device provides doctors with objective and quantitative information for clinical decision support. Nervtex says the device is the first video-based AI-powered medical device that is able to assess movement disorders. More details....<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-02-01T11:07:00-00:00 CS Pharma Acquires China Rights to Fibrosis Drug in $336 Million Agreement http://www.aprdic.com/articles/cspharma-fibrosis-336-million <p>CS Pharmaceuticals, a London company with offices in&nbsp;Beijing&nbsp;and&nbsp;Shanghai, entered a $336 million agreement for greater China rights to a PRS inhibitor, Bersiporocin, for Idiopathic Pulmonary Fibrosis (IPF) from South Korea&rsquo;s Daewoong. Daewoong will receive&nbsp;$76 million&nbsp;in upfront and development milestone payments, plus double-digit royalties on sales. CS, a company that brings rare disease and ophthalmology products to China, may extend the indication for Bersiporocin to other respiratory and fibrotic conditions. More details....<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-31T11:18:00-00:00 CARsgen to Test Claudin18.2 mAb with Roche’s PD-L1 for Gastric Cancer http://www.aprdic.com/articles/carsgen-roche-claudin182 <p>Shanghai CARsgen Therapeutics and Roche formed a collaboration to test a combination of CARsgen&rsquo;s Claudin18.2-targeting mAb and Roche&rsquo;s atezolizumab, a PD-L1 checkpoint inhibitor, in patients with gastric cancer. Most of CARgen&rsquo;s focus is on CAR-T candidates (including a Claudin18.2 CAR-T), but it is also developing a single mAb candidate -- AB011. Roche will be responsible for the co-funded study, using its Morpheus Platform, a collection of Phase Ib/II clinical trials designed to address cancers with high unmet needs. The two companies will co-share the costs of the AB011 treatment arms. More details....</p> <p>Stock Symbol:&nbsp;(HK: 2171)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-31T10:54:00-00:00 Help Therapeutics to Start Trial of Universal Cell Therapy for Heart Failure http://www.aprdic.com/articles/help-cell-therapy-heart <p>Beijing Help Therapeutics was approved to start China clinical trials of HiCM-188, a universal allogeneic iPS cell-derived cardiomyocyte therapy in patients with ischemic heart failure. It has already begun similar trials in Japan and Germany. The therapy consists of highly purified allogeneic cardiac muscle cells that are reprogrammed from human iPS cells. The transplanted cardiomyocytes are expected to couple electrically with the patient's myocardium to cause remuscularization. Founded in 2016, Help claims to be China&rsquo;s first company to use induced pluripotent stem cells and mesenchymal stem cell technology to develop universal cell therapies for unmet needs in degenerative diseases. More details....<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-30T11:59:00-00:00 HuidaGene’s CRISPR Therapy Approved to Start US Trial for Inherited Retinal Disease http://www.aprdic.com/articles/huidagene-crispr-us-trial <p>HuidaGene Therapeutics, a Shanghai-New Jersey gene editing company, was cleared to start a US Phase I trial of its lead product, a CRISPR-based genomic medicine for patients with inherited RPE65 retinal dystrophies. RPE65&nbsp;retinal dystrophies are a group of genetic diseases caused by mutations in the RPE65&nbsp;gene that affect the retina, causing blindness in 100% of patients by age 40. The company believes its optimized CRSPR/Cas-based RNA editing tools are smaller, more efficient, and more specific than the competition, allowing lower dosing of its AAV vectors. It expects the candidate will be a one-time therapy for RPE65 retinal disorders. More details....<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-30T11:49:00-00:00 Week in Review: HutchMed Announces $1.1 Billion Deal with Takeda for Colorectal Cancer Drug http://www.aprdic.com/articles/wir-hutchmed-1-billion-takeda <p><b><i>Deals and Financings</i></b></p> <ul> <li>Shanghai&rsquo;s HutchMed out-licensed global rights (ex-China) for a colorectal cancer therapy to Japan&rsquo;s Takeda (TSE: 4502) in a deal worth up to $1.1 billion ($400 million upfront);</li> <li>HBM Alpha Therapeutics, a novel endocrine disease biotech incubated by Harbour BioMed of the US and China, completed a seed financing of undisclosed size;</li> </ul> <p><b><i>Trials and Approvals</i></b></p> <ul> <li>Guangzhou Akeso was approved for a China launch of penpulimab, an anti PD-1 mAb, as a first-line treatment for squamous non-small cell lung cancer;</li> <li>Legend Biotech, a New Jersey-Nanjing biotech, announced its CAR-T therapy improved Progression Free Survival compared to standard therapies in multiple myeloma patients;</li> <li>Shanghai Junshi Biosciences&rsquo; NDA for a COVID-19 treatment has been accepted for review by China&rsquo;s NMPA;</li> <li>Hangzhou Ascletis reported&nbsp;China&nbsp;approved its&nbsp;IND&nbsp;for ASC10, an oral treatment for monkeypox that is also being tested in SARS-CoV-2 patients.</li> </ul> <p>Stock Symbols:&nbsp;(NSDQ/AIM: HCM, HK: 13)&nbsp;(HK: 02142)&nbsp;(HK: 9926)&nbsp;(NSDQ: LEGN) (HK: 1877; SHA: 688180)&nbsp;(HK: 1672)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-28T10:13:00-00:00 Legend Reports CAR-T Meets PFS Endpoint as Second-line Therapy for MM http://www.aprdic.com/articles/legend-car-t-2nd-line-mm <p>Legend Biotech, a New Jersey-Nanjing biotech, announced its CAR-T therapy improved Progression Free Survival compared to standard therapies in patients with relapsed-refractory multiple myeloma. The results came from a global Phase III trial that enrolled patients with as few as one prior round of therapy. The company did not release specific data from the trial. One year ago, the candidate, Carvykti&reg; (cilta-cel), was approved in the US and EU as a fifth-line therapy for R/R MM. In late 2017, Janssen paid $350 million upfront to partner the drug with Legend. More details....</p> <p>Stock Symbols:&nbsp;(NSDQ: LEGN)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-27T10:42:00-00:00 HBMAT, a Harbour Biomed JV, Closes Seed Round for Novel Endocrine Therapies http://www.aprdic.com/articles/hbmat-harbour-jv <p>HBM Alpha Therapeutics&nbsp;(HBMAT), a novel endocrine disease biotech incubated by Harbour BioMed&nbsp; of the US and China, completed a seed financing to advance its two leading candidates.&nbsp;The company is developing novel antibody therapies for congenital adrenal hyperplasia and polycystic ovary syndrome, with the lead candidate currently in IND-enabling stage. HBMAT, headquartered in Cambridge, MA is a JV formed by HBM and Boston Children's Hospital, an affiliate of Harvard Medical School, which owned the original rights to the two candidates. The financing will be used to advance the molecules into clinical trials. More details....</p> <p>Stock Symbol:&nbsp;(HK: 02142)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-27T10:31:00-00:00 Ascletis IND Approved to Start China Trials of Prodrug for Monkeypox http://www.aprdic.com/articles/ascletis-trial-monkeypox <p>Hangzhou Ascletis reported <st1:country-region w:st="on">China</st1:country-region> approved its <st1:state w:st="on"><st1:place w:st="on">IND</st1:place></st1:state> for ASC10, an oral treatment for monkeypox. The company described ASC10 as a double prodrug consisting of ASC10 and the single prodrug molnupiravir, a COVID therapy, which are converted&nbsp;<i>in vivo</i>&nbsp;into the same active metabolite ASC10-A. In preclinical studies, ASC10-A has shown broad spectrum antiviral activity against monkeypox and SARS-CoV-2 viruses. Ascletis has completed a Phase I safety trial in <st1:country-region w:st="on"><st1:place w:st="on">China</st1:place></st1:country-region> for ASC-10 as a therapy for COVID. Monkeypox is an orthopoxvirus that causes symptoms similar to smallpox. More details....</p> <p>Stock Symbol:&nbsp;(HK: 1672)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <br /><br /></p> 2023-01-26T10:35:00-00:00 Akeso Approved to Market PD-1 in China as First-Line NSCLC Therapy http://www.aprdic.com/articles/akeso-pd1-nsclc <p>Guangzhou Akeso was approved to market penpulimab, an anti PD-1 mAb, as a first-line treatment in <st1:place w:st="on"><st1:country-region w:st="on">China</st1:country-region></st1:place> for squamous non-small cell lung cancer. Akeso co-developed the drug with Sino Biopharma. In August, 2021, the drug was approved as a third line therapy to treat classic Hodgkin's lymphoma. Last month, Akeso out-licensed ex-China rights for its bispecific PD-1/VEGF candidate to <st1:place w:st="on"><st1:state w:st="on">California</st1:state></st1:place>'s Summit Therapeutics in a deal worth up to $5 billion ($500 million upfront). Akeso develops first-in-class and best-in-class medicines for global markets. More details....</p> <p>STock Symbols:&nbsp;(HK: 9926)&nbsp;(HK: 1177)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <br /><br /></p> 2023-01-25T10:13:00-00:00 Junshi Bio’s NDA for COVID-19 Therapy Accepted for Review in China http://www.aprdic.com/articles/junshi-nda-covid <p>Shanghai Junshi Biosciences&rsquo; NDA for a COVID-19 treatment has been accepted for review by China&rsquo;s NMPA. The Deuremidevir Hydrobromide Tablet, known as VV11, is an oral nucleoside analog anti-SARS-CoV-2 drug that inhibits the replication of SARS-CoV-2. In a Phase III trial, it lowered recovery time compared to Pfizer&rsquo;s Paxlovid, the current standard of care. VV116 was developed by a network of China government institutes, including the Shanghai Institute of Materia Medica, plus Suzhou Vigonvita Life Sciences and Junshi Bio. More details....</p> <p>Stock Symbols:&nbsp;(HK: 1877; SHA: 688180)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-24T10:04:00-00:00 HutchMed Out-licenses Rights for VEGFR to Takeda in $1.1 Billion Deal http://www.aprdic.com/articles/hutchmed-takeda-1-billion <p>Shanghai&rsquo;s HutchMed out-licensed global rights (ex-China) for a colorectal cancer therapy to Japan&rsquo;s Takeda in a deal worth up to $1.13 billion, including $400 million upfront. Fruquintinib, an oral drug, inhibits VEGFR-1-2 and 3. In China, the drug has been approved for use in CRC since 2018, and HutchMed is currently filing for US and EU approval. HutchMed believes fruquintinib has the potential to be used in subtypes of refractory metastatic colorectal cancer, regardless of biomarker status. In addition to the $1.13 billion, HutchMed will also pay royalties on net sales. More details....</p> <p>Stock symbols:&nbsp;(NSDQ/AIM: HCM, HK: 13)&nbsp;(TSE: 4502)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-23T11:08:00-00:00 Week in Review: Mabwell Out-Licenses Rare Disease Drug for $412.5 Million http://www.aprdic.com/articles/wir-mabwell-412-million <p><b><i><span style="color: #666666;">Deals and Financings</span></i></b></p> <ul> <li><span style="color: #666666;"> </span><span style="color: #666666;">Shanghai Mabwell Biosciences out-licensed global rights (ex-China) for a rare disease drug to Disc Medicine of Cambridge, MA in a $412.5 million agreement;</span></li> <li><span style="color: #666666;"> </span><span style="color: #666666;">Aprinoia Therapeutics, a company developing products for neurodegenerative diseases, agreed to merge with a SPAC at an implied value of $280 million;</span></li> <li><span style="color: #666666;"> </span><span style="color: #666666;">GenScript ProBio of Nanjing, a biologics CDMO that is majority owned by gene synthesis company GenScript Biotech, raised $224 million in a C round;</span></li> <li><span style="color: #666666;"> </span><span style="color: #666666;">Shanghai CARsgen out-licensed China commercialization rights for its lead asset, a BCMA CAR T, to Huadong Medicine for $181 million;</span></li> <li><span style="color: #666666;"> </span><span style="color: #666666;">Structure Therapeutics, a South San Francisco-Shanghai company developing GPRC drugs based on structural design, filed for a $100 million IPO on NASDAQ;</span></li> <li><span style="color: #666666;"> </span><span style="color: #666666;">Nanjing IASO Bio completed a $75 million&nbsp;Series C1 funding to support its novel autologous and allogeneic CAR-T and biologic products;</span></li> <li><span style="color: #666666;"> </span><span style="color: #666666;">Shanghai Ronovo Surgical has raised $50 million including its latest round to conduct a clinical trial for its first robotic laparoscopic surgery device, Carina&trade;;</span></li> <li><span style="color: #666666;"> </span><span style="color: #666666;">Tigermed, a full-service Hangzhou CRO, acquired Marti Farm, a European CRO based in Zagreb, Croatia;</span></li> </ul> <p><b><i><span style="color: #666666;">Trials and Approvals</span></i></b></p> <ul> <li><span style="color: #666666;"> </span><span style="color: #666666;">Shanghai Henlius Biotech has been approved to launch its anti-PD-1 mAb in China as a first-line treatment for extensive stage small cell lung cancer.</span></li> </ul> <p><span style="color: #666666;">Stock Symbols: (SHA: 688062) (HK: 2171)&nbsp;(SHZ: 000963) (SHZ: 300347; HK: 3347) (HK: 2696)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></span></p> 2023-01-21T09:43:00-00:00 Mabwell Out-licenses Rare Disease Drug to Disc Medicine for $412.5 Million http://www.aprdic.com/articles/mabwell-out-licenses-412-million <p>Shanghai Mabwell Biosciences out-licensed global rights (ex-China) for a rare disease drug to Disc Medicine of Cambridge, MA in a $412.5 million agreement. The candidate, 9MW3011, is a first-in-class macromolecule drug that regulates iron homeostasis in vivo and aims to treat rare diseases including&beta;-thalassemia and polycythemia vera. It has been approved to start trials in the US and China. Mabwell will receive $10 million upfront and $402.5 million in milestones plus single digit royalties on sales. More details....</p> <p>Stock Symbol:&nbsp;(SHA: 688062)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-20T10:41:00-00:00 Tigermed Expands Footprint and Services by Acquiring Marti Farm, a Croatian CRO http://www.aprdic.com/articles/tigermed-marti-farm <p>Tigermed, a full-service Hangzhou CRO, acquired Marti Farm, a European CRO based in Zagreb, Croatia. Marti Farm offers pharmacovigilance, clinical operations and regulatory services to pharma and cosmetic companies. Over the past 12 years, it has worked with 150 companies in 50 countries. Tigermed said it expects the acquisition will increase its presence in Europe, offering CRO services to biopharmas, while it expands Marti Farm&rsquo;s cloud-based pharmacovigilance capabilities to global clients. The terms of the acquisition were not disclosed. More details....</p> <p>Stock Symbols:&nbsp;(SHZ: 300347; HK: 3347)<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-20T10:32:00-00:00 Aprinoia, a Neurodegenerative Company, to be Acquired by $280 Million SPAC http://www.aprdic.com/articles/aprinoia-280-million <p>Aprinoia Therapeutics, a company developing products for neurodegenerative diseases, agreed to merge with a SPAC at an implied business combination value of $280 million. The SPAC is Ross Acquisition Corp II (NYSE: ROSS). The company&rsquo;s lead product is a PET tracer for tau &nbsp;currently in a China Phase III trial, targeting tauopathies. In addition, Aprinoia announced it has out-licensed China rights for the tau tracer to an unnamed large biotech company for an unspecified amount. Aprinoia believes its tracer has a higher specificity than older generations of the diagnostic. Now headquartered in Cambridge, MA, Aprinoia was previously based in Hong Kong and Taipei. More details....<!-- New ShareThis code - Small chiclets - New line--> <br /> <br /> Share this with colleagues: <span class="st_twitter"></span> <span class="st_linkedin"></span> <span class="st_facebook"></span> <span class="st_email"></span> <span class="st_sharethis"></span> <script type="text/javascript">// <![CDATA[ var switchTo5x=true; // ]]></script> <script type="text/javascript" src="http://w.sharethis.com/button/buttons.js"></script> <script type="text/javascript">// <![CDATA[ stLight.options({publisher:'d7871f5b-67bc-4d30-b66f-1465d0b97213'}); // ]]></script> <!-- Place this tag where you want the +1 button to render --> &nbsp;<g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p> 2023-01-19T11:44:00-00:00 18վ,ȺƵԴ,ִˬӲԻƤƵ
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