China

Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.

The nod will help unlock a national market for the partners’ Dupert (fulzerasib) in which roughly 50,000 people are expected to be newly diagnosed with lung cancer harboring the KRAS G12C mutation in 2025. Meanwhile, two other homegrown rivals are also closing in on marketing clearances in China.

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."

We may then state the above equation in this way: The work done by the resultant force acting on a particle is equal to the change in the kinetic energy of the particle.

Vitestro's automated blood drawing robot received CE marking on August 28. The company is limiting release of the robot over the next 12 months to a small number of selected hospitals, with plans to scale up production thereafter.

China has seen a “milestone year for the overseas launch of domestically produced innovative drugs.”

Generics Bulletin reviews the latest regulatory events across the world.

An employee of Astellas in China first detained 17 months ago on suspicion of espionage has been formally indicted and now faces trial. 

Being the Chinese biotech’s backbone asset in the autoimmune disease area, telitacicept, a BlyS/APRIL dual targeting fusion protein, has hit its target in a China-only Phase III study in generalized myasthenia gravis. The candidate is also being investigated in global Phase III trials in systemic lupus erythematosus and Sjögren's syndrome.

Request to recall eye drops should be fulfilled promptly and businesses providing lip balms as promotional products must verify contract manufacturers are compliant, recent FDA warnings states. Additional letters went to Jordanian firm about testing alcohol for methane and to a Chinese firm advised that compliance with China’s quality control standards isn’t sufficient.

If closed successfully, the traditional producer of active pharmaceutical ingredients and generic drugs will scoop up the world’s second advanced KRAS G12D-targeting T-cell receptor (TCR) T cell therapy candidate, as well as an EGFR variant III-targeting chimeric antigen (CAR) receptor T-cell agent. Out-licensing efforts are already under way.

July was an active month for deals between Chinese biopharma firms, as some looked to build their pipelines and others for partners to help commercialize products moving to market. Two ADCs, a GLP-1R/GIPR fusion protein and an IL-4Rα antibody were among the assets changing hands.

Kenvue maintains full-year guidance after 0.3% Q2 net sales dip beat market expectations. Essential health segment alone drove sales; self-care and skin health/beauty faltered. US sales of Neutrogena Collagen Bank pre-aging platform launched on TikTok shop, a first for the brand.

China’s top drug regulator is implementing a pilot program offering shorter review times for IND applications to improve the quality and efficiency of clinical studies and stimulate the country’s innovative drug sector.

Shanghai issues a new set of policies and financial incentives designed to support and speed up regulatory and commercial activities in the biopharma sector, in a comprehensive stimulus package for companies based in the major Chinese city.

L’Oréal's European business recorded sales growth of 9.7% to €3.55bn in the second quarter as consumer confidence grows, while in the US sales slowed for the dermatological beauty business and consumers in China are value-shopping.

RNK Pharma founder and CEO Yaning Wang joins Brian Yang to discuss the latest biopharma stimulus policies offered by Shanghai and the globalization of China biotech. Dexter Yan also talks about China biotech initial public offering trends in the first half of this year. 

HPV vaccine shipments to China are expected to fall after a government crackdown on bribery and corruption caused scientific communication with health care providers to decline. Gardasil also may be hurt by budgetary pressures on distribution of the government-reimbursed vaccine.