ChinaBio® Today
http://www.chinabiotoday.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. BeiGene PD-(L)1 Inhibitor Approved in US for Esophageal Carcinoma
http://www.chinabiotoday.com/articles/beigene-pd1-us-approval
<p>BeiGene was approved to market Tevimbra® (tislelizumab-jsgr) in the US for patients with unresectable or metastatic esophageal squamous cell carcinoma. Patients must have previously been treated with chemotherapy that did not include a PD-(L)1 inhibitor. The approval took a very long 20 months because US regulators were not allowed to inspect BeiGene’s manufacturing plant due to COVID restrictions. At one point, BeiGene had out-licensed Tevimbra to Novartis in a $2.2 billion deal ($650 million upfront). Novartis returned the rights to BeiGene six months ago, claiming that regulatory problems soured the deal. More details....</p>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-18T09:47:00-00:00KeChow Approved to Launch Tunlametinib for Melanoma Patients in China
http://www.chinabiotoday.com/articles/kechow-launch-melanoma
<p>Shanghai KeChow Pharma was approved to market tunlametinib in China to treat patients with NRAS mutated advanced melanoma who were previously treated with PD-1/PD-L1. Tunlametinib, KeChow’s lead candidate, is a small molecule inhibitor of Mitogen-activated protein kinase (MEK). KeChow believes its candidate does a better job of inhibiting targets and improving pharmacokinetics than already approved MEK inhibitors. The company, which owns global rights to tunlametinib, plans to develop the drug in China as a monotherapy and in combination with other standard of care therapies to treat additional cancers. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-18T09:39:00-00:00Week in Review: Under Pressure from US Congress, WuXi AppTec Resigns from BIO
http://www.chinabiotoday.com/articles/wir-bio-wuxi-apptec
<p><b><i><span>Company News:</span></i></b></p>
<ul>
<li><span> WuXi AppTec resigned from </span><span>BIO, the global lobbying organization for biotechnology firms, after the US Congress put pressure on BIO to cut ties with the global, China-headquartered CRDMO;</span></li>
</ul>
<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;">Germany’s Boehringer Ingelheim optioned a license to a Phase I schizophrenia therapy from Sosei Heptares of Japan in an $822 million agreement;</span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;">Jiangsu Hansoh enters $700 million deal for global rights to Zuhai’s proprietary anti-EGFR/cMet bispecific antibodyl;</span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;">PegBio, a Suzhou biotech, filed for a Hong Kong IPO to support commercialization of its long-acting pegylated GLP-1 receptor agonist for type 2 diabetes and obesity;</span></li>
</ul>
<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;">Yantai RemeGen said an interim analysis of its anti-HER2 antibody drug conjugate showed efficacy in the cervical cancer cohort of a China Phase II trial;</span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;">Ranok Therapeutics, a Hangzhou-Boston biopharma that targets protein degradation to treat cancers, started a China Phase I study of its lead candidate;</span></li>
<li><span style="color: #666666;">Singapore’s Aslan Pharma reported positive data from a head-to-head study of eblasakimab versus dupilumab in COPD.<!-- 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>
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</ul>2024-03-16T08:45:00-00:00Boehringer Options Schizophrenia Candidate from Japan’s Sosei in $822 Million Deal
http://www.chinabiotoday.com/articles/boehringer-sosei
<p>Germany’s Boehringer Ingelheim optioned rights to a schizophrenia therapy that treats all symptoms of the disease from Sosei Heptares of Japan in an agreement worth up to $822 million. Sosei Heptares is currently conducting a Phase I trial of a first-in-class GPR52 agonist for the indication. BI will have an option to acquire the agonists after Sosei completes Phase Ib trials. Sosei expects the chosen candidate will be effective against all symptoms of the disease, which are separated into positive (psychosis, delusions and hallucinations), negative (withdrawal and apathy) and cognitive (attention, planning and memory deficits) 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-15T09:36:00-00:00Hansoh Adds Global Rights for Zhuhai’s Bispecific in $700 Million Deal
http://www.chinabiotoday.com/articles/hansoh-global-zhuhai
<p>Jiangsu Hansoh Pharma extended its partnership with Zhuhai Biotheus, acquiring global rights to Zuhai’s proprietary anti-EGFR/cMet bispecific antibody in a $700 million agreement. Two years ago, Hansoh acquired China rights to the candidate for $207 million. Now, the company will be in charge of taking the bispecific to global markets, although it does also have rights to sublicense it. Zhuhai’s candidate is a 1+1 heterodimeric EGFR/cMet bispecific antibody, designed to inhibit the growth and survival of tumors. It is currently in Phase I clinical trials to treat solid tumors including non-small-cell lung cancer. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-15T09:27:00-00:00BIO Switches Gears, Forcing WuXi AppTec Out of Organization
http://www.chinabiotoday.com/articles/bio-reverses-wuxi-apptec
<p>BIO, the global lobbying organization for biotechnology firms, has forced WuXi AppTec to leave the group due to pressure from the US Congress. The Committee on the Chinese Communist Party, a US Congressional committee, objected to BIO’s attempt to stop the BIOSECURE Act, which was written to prevent any taxpayer money from being spent on WuXi AppTec’s CRDMO businesses. The Congressional committee is also worried that WuXi, which has several facilities in the US, would use genetic data gathered from clinical trials to harm US citizens. WuXi sent a letter to BIO yesterday, saying that it will resign from the organization. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-14T10:42:00-00:00PegBio Plans Hong Kong IPO to Support Long Acting GLP-1 for Diabetes/Obesity
http://www.chinabiotoday.com/articles/pegbio-hk-ipo
<p>PegBio, a Suzhou biotech, has filed for a Hong Kong IPO to support commercialization of its long-acting pegylated GLP-1 receptor agonist for type 2 diabetes and obesity. The company says its pegylated technology will require only a once-weekly administration for PB-119. PegBio has filed for NMDA approval of the drug, which has completed two China Phase III trials in T2DM patients, one as a monotherapy and the other in combination with metformin. The company expects a ruling in late 2024, allowing for a launch in early 2025. It has five additional novel products in development. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-14T10:36:00-00:00Aslan Pharma Offers Data Showing Eblasakimab Effective in COPD
http://www.chinabiotoday.com/articles/aslan-copd
<p>Singapore’s Aslan Pharma reported new positive translational data from a head-to-head study of eblasakimab versus dupilumab in a human tissue model of chronic obstructive pulmonary disease (COPD). Eblasakimab is a mAb that targets the IL-13 receptor subunit of the Type 2 receptor, a pathway that drives several allergic inflammatory diseases. Aslan believes the candidate has the potential to outperform current biologics that are used to treat allergic diseases. More details....</p>
<p>Stock Symbol: (NSDQ: ASLN)<!-- 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-12T08:58:00-00:00Ranok to Start China Trial of Protein Degrader for Solid Tumors and Lymphomas
http://www.chinabiotoday.com/articles/ranok-china-trial
<p>Ranok Therapeutics, a Hangzhou-Boston biopharma that targets protein degradation for the treatment of cancers, started a China Phase I study of RNK05047, its lead protein degrader candidate. RNK05047 is a first-in-class, small-molecule, tumor- and BRD4-selective protein degrader discovered by Ranok. The company already has a US-based Phase I trial of the candidate underway. The China trial will enroll Chinese patients with advanced solid tumors or lymphomas. Ranok expects to report preliminary data from the two Phase 1 studies by the end of 2024. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-12T08:48:00-00:00RemeGen Says anti-HER2 ADC Effective for Cervical Cancer
http://www.chinabiotoday.com/articles/remegen-her2-cervical
<p>Yantai RemeGen said an interim analysis of its anti-HER2 antibody drug conjugate (ADC) showed efficacy in the cervical cancer cohort of a China Phase II trial. The Phase II open-label trial is currently testing Disitamab Vedotin (RC48) as a monotherapy in patients with HER2-expressing gynecologic malignancies. In June 2021, RC48 was granted conditional approval in China for locally advanced or metastatic gastric cancer. Three years ago, RemeGen out-licensed ex-China rights for RC48 to Seattle’s Seagen in a $2.6 billion ($200 million upfront) agreement. More details....</p>
<p>Stock Symbols: (HK: 9995; SHA: 688331)<!-- 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-11T10:04:00-00:00Week in Review: EurekaBio Raises $40 Million to Support Lentiviral Vector Platform
http://www.chinabiotoday.com/articles/wir-eurekabio-40-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;">Shenzhen EurekaBio closed a $40 million Series B+ funding to support the launch of its EuLV™ Lentiviral Vector Production System, a novel technology;</span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;">Chengdu Maxvax Biotechnology raised $40 million in a Series C financing round to advance its portfolio of seven vaccines, two of which are in clinical trials;</span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;">Hangzhou Zylox-Tonbridge entered a $15 million deal for China rights to the neurovascular device portfolio of California’s Avinger;</span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;"><span style="color: #666666;">Shanghai Haihe Biopharma out-licensed Japan rights for its lead drug, gumarontinib, an approved therapy for NSCLC, to Taiho Pharma of Tokyo.</span></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;">Suzhou Innovent and AnHeart Therapeutics of Hangzhou filed a second NDA of their partnered next-gen ROS1 TKI in China for NSCLC;</span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;">Beijing’s Akeso enrolled the first patient in a Phase III clinical trial of its PD-1/CTLA-4 bispecific antibody as a first-line treatment for PD-L1 negative NSCLC;</span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;">Nanjing TransThera was approved to begin a European Phase III trial of tinengotinib in patients with cholangiocarcinoma;</span></li>
<li><span style="color: #666666;">Jinan Qilu Pharma presented data from a Phase II trial showing that its PD-1/CTLA-4 combination therapy was effective against cervical cancer.</span></li>
</ul>2024-03-09T09:40:00-00:00EurekaBio Raises $40 Million for New Lentiviral Vector Production System
http://www.chinabiotoday.com/articles/eurekabio-40-million
<p>Shenzhen EurekaBio closed a $40 Series B+ funding to support the commercialization of its EuLV™ Lentiviral Vector Production System, a technology that the company believes could transform large-scale production of lentiviral vectors. The system is based on stable cell lines and a serum-free suspension system. Eureka believes its novel technology will have a major impact in how cell and gene therapies are developed. The B+ round was led by Yeuxiu Industrial Fund, with participation from China funds and follow-on investments from US funds. More detail....<!-- 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-08T10:30:00-00:00Chengdu Maxvax Bio Raises $40 Million for Vaccines and Immunotherapies
http://www.chinabiotoday.com/articles/maxvax-40-million
<p>Chengdu Maxvax Biotechnology raised $40 million in a Series C financing round to advance its portfolio of seven vaccines, two of which are in clinical trials. The company develops innovative vaccines and immunotherapies to prevent and treat infectious diseases and cancer. Maxvax, which has five subsidiaries with over 300 employees, was founded in 2016. The company applies its three platforms -- adjuvant, recombinant protein and mRNA technology – to develop novel products. The company has been recognized as a national high-tech enterprise. The C round was funded exclusively by the Shenzhen Capital Group. More detail....<!-- 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-08T10:09:00-00:00Zylox-Tonbridge Acquires China Rights to Vascular Devices for $15 Million
http://www.chinabiotoday.com/articles/zylox-vascular-15-million
<p>Hangzhou Zylox-Tonbridge, a peripheral and neurovascular interventional device company, entered a $15 million deal to distribute and manufacture the entire device line of California’s Avinger in China. Avinger offers intra-vascular image-guided, catheter-based systems for diagnosis and treatment of vascular disease. Zylox-Tonbridge, which will have Greater China rights to the products, will buy $7.5 million of Avinger stock upfront and the rest after technology transfer. Avinger will also have distribution rights in the US and Germany for Zylox-Tonbridge’s peripheral vascular products. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-08T10:03:00-00:00Akeso Starts China Phase III Trial of PD-1/CTLA-4 Bispecific for NSCLC
http://www.chinabiotoday.com/articles/akeso-pthree-bispecific
<p>Beijing’s Akeso (HK: 9926) enrolled the first patient in a Phase III clinical trial of cadonilimab (a PD-1/CTLA-4 bispecific antibody) as a first-line treatment for patients with PD-L1 negative non-small cell lung cancer. Cadonilimab will be combined with chemotherapy and compared to tislelizumab (a PD-1 antibody) combined with chemotherapy. Cadonilimab, which is being tested in more than 60 ongoing clinical studies, is already approved as a second/third line therapy for advanced cervical cancer, and it has completed a successful Phase III trial as a first-line gastric cancer therapy. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-08T09:49:00-00:00TransThera to Start European Arm of Global Trial for Bile Tube Cancer
http://www.chinabiotoday.com/articles/transthera-europe-bile
<p>Nanjing TransThera was approved to begin a European Phase III trial of tinengotinib in patients with cholangiocarcinoma (CCA). CCA, a cancer in the tubes that carry the digestive fluid bile through the liver, is a rare but aggressive form of cancer. To be enrolled, patients must have FGFR-altered disease that is refractory/relapsed from chemotherapy or a FGFR Inhibitor. The European Phase III trial is part of a global study of the drug. Tinengotinib, a next-gen FGFR inhibitor, has shown potency against a variety of FGFR2 kinase domain mutations in Phase I and II trials for the CCA indication. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-08T09:37:00-00:00Innovent/AnHeart File China NDA for ROS1 Inhibitor to Treat NSCLC
http://www.chinabiotoday.com/articles/innovent-anheart-ros1
<p>Suzhou Innovent and AnHeart Therapeutics of Hangzhou have filed a second NDA of their partnered next-gen ROS1 TKI in China. The new NDA, which has been accepted for review by China’s CDE, is for use of taletrectinib as a first-line therapy for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have not previously been treated with a ROS1 TKI. The first NDA filing was for NSCLC patients who have been previously treated with ROS1 TKIs. In 2021, Innovent entered a $189 million agreement with AnHeart to commercialize taletrectinib in Greater 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-05T10:58:00-00:00Haihe Out-Licenses Japan/Asia Rights for NSCLC Therapy to Taiho Pharma
http://www.chinabiotoday.com/articles/haihe-out-licenses-nsclc
<p>Shanghai Haihe Biopharma out-licensed Japan and Southeast Asia rights for its lead drug, gumarontinib, an approved therapy for non-small cell lung cancer, to Taiho Pharma of Tokyo. In March 2023, gumarontinib was approved in China to treat non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping mutations. Haihe has already applied for Japanese approval of the drug. Taiho will have rights to develop, manufacture and commercialize gumarontinib in its areas. Haihe will receive an upfront payment, and it will be eligible for milestones and royalties based on sales revenues. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-04T10:58:00-00:00Qilu Says PD-1/CTLA-4 Combo Effective Against Cervical Cancer
http://www.chinabiotoday.com/articles/qilu-combo-cervical
<p>Jinan Qilu Pharma presented data from a Phase II trial showing that its QL1706 combination therapy of a PD-1 and CTLA-4 was effective against cervical cancer. The combination met its primary endpoint with an objective response rate of 33.8%. In August 2023, China’s NMPA accepted a new drug application for QL1706, the first MabPair product targeting PD-1 and CTLA-4 worldwide. Qilu will present the trial data at The European Society of Gynecological Oncology (ESGO) 2024 Conference later this week. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-04T10:50:00-00:00Week in Review: Mabwell Sells Ex-China Rights to Rare Disease Therapy in $412 Million Deal
http://www.chinabiotoday.com/articles/wir-mabwell-rare-disease
<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;">Mabwell, a Shanghai-San Diego biotech, sold ex-China rights for its serum iron regulator to Disc Medicine of Watertown, MA in a deal worth up to $412 million;</span></li>
<li><span style="color: #666666;">Zhuhai’s Biotheus formed a multi-year collaboration with Bitterroot Bio of Palo Alto to discover novel approaches that regulate inflammation;</span></li>
<li>Jiangsu Nhwa Pharma formed a China partnership to distribute a Teva Pharma therapy that treats two neurodegenerative and movement disorders; </li>
<li>AstraZeneca has returned most of the global rights for Roxadustat to FibroGen, though it will retain the rights for China and South Korea, where the drug is approved;</li>
</ul>
<p><b><i><span style="color: #666666;">Company News</span></i></b><b><i><span style="color: #666666;"> </span></i></b></p>
<ul>
<li><span style="color: #666666;"> </span><span style="color: #666666;">AstraZeneca announced that it will locate its fifth global strategic center in Shanghai, including China/Asia commercial operations and R&D;</span><b><i><span style="color: #666666;"> </span></i></b></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’s CARsgen Therapeutics was approved for a China launch of its autologous BCMA CAR-T product in patients with multiple myeloma;<i></i></span></li>
<li><span style="color: #666666;">Longbio Pharma (Suzhou) released results from a Phase II trial showing its lead drug was effective in patients with allergic rhinitis;</span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;">Shanghai Everest Medicines and Kezar Life Sciences of South San Francisco will start a China Phase IIb trial of their partnered drug for lupus nephritis; </span></li>
<li><span style="color: #666666;"> </span><span style="color: #666666;">BioCity Biopharma, a clinical-stage company located in Wuxi, has enrolled all 120 participants in the first arm of its trial of a selective ETA-receptor antagonist for chronic kidney disease; </span></li>
<li><span style="color: #666666;">Suzhou Innovent Biologics dosed the first patient in an Australian Phase I trial of a global first-in-class IL-4Rα/TSLP bispecific antibody for asthma.<!-- 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></span></li>
</ul>2024-03-02T09:35:00-00:00CARsgen Approved to Launch BMA CAR-T in China for Multiple Myeloma
http://www.chinabiotoday.com/articles/carsgen-launch-mm
<p>Shanghai’s CARsgen Therapeutics was approved for a China launch of zevorcabtagene autoleucel, its autologous BCMA CAR-T product, in patients with relapsed or refractory multiple myeloma. Patients must have progressed after at least 3 lines of therapy (including a proteasome inhibitor and immunomodulator agent). The approval of zevorcabtagene autoleucel is based on an open-label, single arm, multi-center China Phase II clinical trial. CARsgen is conducting a separate Phase <span><span style="color: #333333;">Ib/II trial </span>in <span style="color: #333333;">North America</span> in the same patient population. The BCMA CAR-T candidate is CARsgen’s first approved product. More details....</span></p>
<p><span>Stock Symbol: (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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></span></p>2024-03-01T10:39:00-00:00Innovent Starts Trials of Bispecific Antibody for Severe Asthma
http://www.chinabiotoday.com/articles/innovent-asthma
<p>Suzhou Innovent Biologics dosed the first patient in an Australian Phase I trial of IBI3002, a global first-in-class bispecific antibody for asthma. IBI3002 is a humanized bispecific antibody that targets cell surface IL-4Rα and the alarmin cytokine TSLP, discovered by Innovent to treat inflammatory diseases, including asthma. TSLP is an epithelial cell-derived alarmin cytokine that triggers both T2 and non-T2 inflammation in asthma. Innovent believes IBI3002, with its dual targets, has the potential to treat several inflammatory diseases. Innovent develops novel medicines for oncology, metabolic, autoimmune and ophthalmology indications. More details....</p>
<p>Stock Symbol: (HKEX: 01801)<!-- 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-03-01T10:31:00-00:00Mabwell Out-Licenses Rare Disease Therapy to Disc in $412 Million Deal
http://www.chinabiotoday.com/articles/mabwell-disc
<p>Mabwell, a Shanghai-San Diego biotech, sold ex-China rights for 9MW3011 to Disc Medicine of Watertown, MA in a deal worth up to $412 million. Mabwell will receive $10 million upfront. 9MW3011 is designed to lower the serum level of iron, regulating iron homeostasis in vivo. It is expected to treat patients with rare diseases including β-thalassemia, polycythemia vera and other conditions related to iron homeostasis. 9MW3011, which has been approved to start trials in China and the US, was developed in Mabwell’s San Diego Innovation R&D Center. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-02-29T10:55:00-00:00AstraZeneca to Build Global Strategic Center in Shanghai
http://www.chinabiotoday.com/articles/astrazeneca-shanghai
<p>AstraZeneca announced that it will locate its fifth global strategic center in Shanghai, joining centers in Cambridge, UK, Boston and Gaithersburg in the US, and Gothenburg, Sweden. The Shanghai center will differ from the other centers because it will include China/Asia commercial and production operations along with R&D. The new center will play a part in AZ’s global strategy, according to the company. Earlier this year, AZ made a dramatic statement of its interest in China's biopharma innovation by spending $1.2 billion to acquire Gracell Bio, a CAR-T development company headquartered in Suzhou. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-02-29T10:48:00-00:00Biotheus to Develop Antibodies With Bitterroot for Cardio-Immunology
http://www.chinabiotoday.com/articles/biotheus-bitterroot
<p>Zhuhai’s Biotheus formed a multi-year collaboration with Bitterroot Bio of Palo Alto to discover novel approaches that modulate the immune system and regulate inflammation, with the goal of addressing atherosclerosis and other potentially fatal cardiovascular conditions. Biotheus will design novel monoclonal and multi-specific antibodies using its proprietary platforms. Bitterroot will add its expertise in cardiovascular medicine and biology to the partnership. Bitterroot is a cardio-immunology company that focuses on the impact of the immune system on cardiovascular health. 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>
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<!-- Place this tag where you want the +1 button to render --> <g:plusone href="/articles/20150311" size="small"></g:plusone> <br /><br /></p>2024-02-28T11:00:00-00:00