A roundup of top stories from China’s pharma industry, including BeiGene’s new US R&D and manufacturing facility; Merck’s purchase of investigational B-cell depletion therapy from Curon Biopharma, and the Chinese approval of AstraZeneca and Daiichi Sankyo’s gastric cancer therapy.
China’s BeiGene opens new clinical R&D and biologics manufacturing facility in US (BioSpectrum Asia)
BeiGene, a China-based oncology company, has announced the opening of its flagship US facility in Hopewell, New Jersey, at the Princeton West Innovation Campus. The new facility features state-of-the-art biologics manufacturing capabilities and a clinical research and development centre that reinforces the company’s distinctive model as an innovator in oncology.
With more than 30 molecules in clinical or commercial stage, the 42-acre facility provides the flexibility to scale up production of its innovative medicines today and in the future, meeting the needs of cancer patients.
Chinese generic drug for breast, pancreatic, and lung cancer approved in EU market (BioSpectrum Asia)
Apexelsin, a generic drug from China been approved by the European Commission. Apexelsin is a generic drug to Bristol Myers Squibb’s and Celgene’s Abraxane(Nab-paclitaxel). Apexelsin is developed by WhiteOak Pharmaceutical B.V. and Kexing Biopharm is in charge of the commercialization of this product out of the US.
Comparatively to solvent-based paclitaxel and liposomal paclitaxel, nanoparticle albumin-bound paclitaxel offers significant advantages for clinical use, providing improved safety and higher patient compliance. Furthermore, ESMO guidelines recommend it as a first-line treatment option for metastatic pancreatic cancer and non-small cell lung cancer (NSCLC), as well as a second-line treatment option for breast cancer.
Merck buys investigational B-cell depletion therapy from Chinese startup Curon Biopharma for $700 M (BioSpectrum Asia)
Merck, known as MSD outside of the United States and Canada, and Curon Biopharmaceutical, a China-based biotechnology startup, has announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire CN201, a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases.
WuXi Biologics and Medigene link on T cell engagers for cancer (Pharmaceutical Technology)
Global contract research, development and manufacturing organisation (CRDMO) WuXi Biologics has partnered with MediGene to develop TCR-guided T cell engagers (TCR-TCEs) for difficult-to-treat tumours. The three-year, multi-target collaboration is intended to design and jointly research TCR-TCEs.
Guideline promotes pharma innovation (China Daily)
China has adopted a guideline to promote the development and availability of innovative drugs, with price management improvements, medical insurance payments, commercial insurance coverage, as well as investment and financing topping the work agenda. Addressing the bottlenecks of pricing, payments and the dominance of incremental innovation are crucial steps for China to unlock the full potential of its pharmaceutical sector, analysts said, calling for the introduction of specific policy measures at an early date.
AstraZeneca and Daiichi Sankyo Receives Chinese Approval for Gastric Cancer Therapy (European Pharmaceutical Manufacturer)
AstraZeneca and Daiichi Sankyo have announced that the duo’s antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from the China National Medical Products Administration (NMPA) for gastric cancer. Now, Enhertu can be used as a single agent for adults with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, as long as they have undergone at least two previous treatments.
German pharmaceutical industry warns of possible drug shortages from China (Euronews)
The German pharmaceutical industry has warning of possible drug shortages after China tightened its espionage laws. Four out of Germany’s 16 states have now cancelled routine quality control trips to China by their inspectors as they’re concerned they could fall foul of the law. The states say they can no longer guarantee the safety of their inspectors on visits to Chinese pharmaceutical factories.
IMBiologics transfers autoimmune disease drug tech to Huadong Pharma (The Korea Economic Daily)
South Korea’s antibody-based biotech company IMBiologics announced on Friday that it signed a contract to transfer the technology of its autoimmune disease treatment candidate to China’s Huadong Pharmaceutical. The contract includes an upfront payment of $8 million, with potential milestone payments of up to $375 million.
The substances being transferred by IMBiologics include two candidates: a bispecific antibody candidate IMB-101, which targets both the autoimmune disease antibody OX40L and tumor necrosis factor (TNF), and a monospecific antibody IMB-102, which targets OX40L only.
BIOSECURE Act hurts US biopharma industry’s confidence in Chinese partners: survey (Fierce Pharma)
Even as the BIOSECURE Act charts an uncertain path through the legislative process, the draft bill has already seriously harmed the U.S. biopharma industry’s perception of Chinese partners.
Among U.S.-based life sciences companies, confidence in working with Chinese companies has dropped by around 30% to 50%, a new survey by L.E.K. Consulting has found. Firms outside the U.S. are less concerned, showing a milder 20% to 30% decrease in their confidence levels, according to the survey.
