Chengdu Baiyu Pharmaceutical Co. Ltd.

CHENGDU, China I October16, 2024 I Chengdu Baiyu Pharmaceutical Co., Ltd. (“Baiyu”) today announced that it has entered into an exclusive license agreement with Novartis for a small molecule anti-tumor asset. Under the terms of the license agreement, Baiyu will receive an upfront payment of $70 million and is eligible to receive additional development, regulatory and commercial milestones payments of up to $1.1 billion, as well as tiered royalties. Novartis has been granted an exclusive worldwide license for the development and commercialization of this asset. BFC Group acted as the exclusive financial advisor to Baiyu. This collaboration is an important step for Baiyu in making potential anti-tumor drugs available to patients globally, and Baiyu look forward to positive results being realized. About Chengdu Baiyu Biopharmaceutical Co., Ltd. Founded in 2005, Baiyu is a pharmaceutical company headquartered in Chengdu, China. The company is dedicated to discover and develop innovative medicines, for which it has earned numerous prestigious national awards. With over 20 years of focused research on the core pharmacological components of Ginkgo biloba, we have successfully developed modern botanical drugs, including Ginkgolide Injection and Ginkgolide Dropping Pills. SOURCE: Chengdu Baiyu Biopharmaceutical

Today, a brief rundown of news from PTC Therapeutics and Novartis, as well as updates from Amylyx Pharmaceuticals and Intercept Pharmaceuticals that you may have missed.Europes drug regulator is standing firm in its decision not to renew the marketing permit for Translarna, a treatment developed by PTC Therapeutics for a rare muscle-wasting disease. The European Medicines Agency initially authorized Translarna in 2014, with the condition PTC gather more data to show the drug is effective in certain cases of Duchenne muscular dystrophy. But after four reviews of the evidence now available, the EMA concluded Translarnas effectiveness still has yet to be confirmed. The agency will send its verdict to the European Commission, which will make the final decision on the drugs status for EU countries. Jacob BellNovartis is paying China-based Chengdu Baiyu Pharmaceutical $70 million for global licensing rights to a single small molecule cancer drug. The deal, which includes up to $1.1 billion in additional payments based on achievement of development and commercial milestones, doesnt specify any biological or disease targets for the drug. Chengdu Baiyu said it is has “focused research on the core pharmacological components of Ginkgo biloba including development of botanical drugs. It has six cancer-related experimental drugs in its pipeline. Jonathan GardnerShares of Amylyx Pharmaceuticals oscillated Thursday with the release of data for one the companys two main drugs. Amylyx said the drug, known as AMX0035, succeeded in a small study of patients with Wolfram Syndrome, a rare, inherited condition that damages organs like the eyes, brain and pancreas. The company now plans to meet with stakeholders, including the Food and Drug Administration, for input on Phase 3 testing, and expects to provide updates on that program next year. AMX0035 had been cleared as a treatment for ALS, but was pulled from the market in April after an important follow-on trial found it wasnt substantially better than a placebo at treating the nerve-destroying disorder. Jacob BellThe Food and Drug Administration has delayed a decision on full approval of Intercept Pharmaceuticals Ocaliva in primary biliary cholangitis, a condition for which the Alfasigma subsidiary won accelerated approval in 2016. The FDA delayed its Oct. 15 decision deadline, but didnt provide a new action date, Intercept said in a statement. The delay follows a negative vote by a panel of independent FDA advisers on Sept. 13. That committee concluded confirmatory trials intended to justify full approval didnt provide enough evidence Ocaliva prevented liver transplants and death in people with the rare disorder. Ocaliva is Intercepts only drug, and generated $286 million in sales in 2022, Intercepts last full year as an independent company. Jonathan GardnerThe Australian agency that regulates pharmaceuticals has decided not to clear for market Leqembi, the closely watched Alzheimers disease drug from Eisai and Biogen. In a statement Wednesday, the Therapeutic Goods Administration said that, based on the available evidence, Leqembis safety risks outweigh its potential benefits. Eisai plans on asking the agency to reconsider its decision. While its approved in the U.S. for people in an early stage of Alzheimers, Leqembi has been met with resistance in Europe and, now, Australia, where estimates hold there are more than 400,000 people with dementia. Jacob BellAmicus has staved off competition for its biggest seller, Fabry disease drug Galafold, until 2037 under the terms of a settlement with Teva Pharmaceuticals. Amicus granted Teva a license to begin selling a generic version of Galafold on Jan. 30 of that year, and the two sides have agreed to drop all federal litigation over Galafold patents. The company continues to fight a second generic manufacturer, Aurobindo, in court. A stay is in place on litigation with a third generic manufacturer, Lupin. Jonathan Gardner '

Novartis is spending $70 million upfront on a small molecule antitumor drug from the Chinese biotech Chengdu Baiyu. The Swiss drugmaker will get an exclusive global license for the development and commercialization of the drug candidate. Baiyu could get up to $1.1 billion in milestones and tiered royalties on product sales, according to a Wednesday release . The companies did not disclose the asset’s mechanism, target indication or stage of development. A Novartis spokesperson said in a statement it would detail future development plans in due course. Nonetheless, the Chengdu-based biotech said it is focused on “exploring new therapeutic modalities to activate the immune microenvironment” and treat traditionally challenging “cold tumors,” which have low response rates to available immunotherapies such as PD-1/PD-L1 drugs. Baiyu has five solid tumor assets in its pipeline , which include mechanisms that target DNA-dependent protein kinase. The biotech’s lead asset is in a Phase 2 study, while another is in a Phase 1 trial. It has been researching and developing drug candidates using ginkgolides, an active ingredient found in ginkgo biloba, for more than a decade. Novartis has had a spate of oncology deals this year. The company bought German antibody biotech MorphoSys for $2.9 billion in February after two decades of collaboration. In May, it expanded its radiopharmaceutical footprint with a $1 billion buyout of Mariana Oncology. Two months later, Novartis spent $150 million upfront on a research pact involving several myeloid engagers developed by Dren Bio. Last month, it announced plans to use $200 million to grow its radioligand manufacturing capabilities, including building a new site in California and expanding an existing site in Indianapolis.