Samsung Bioepis Co., Ltd.

China's breakthrough brain-computer interface approval, AstraZeneca's cell therapy investments in China and the end of a collaboration between Astellas and CytomX Therapeutics made our news this week. China has approved the world's first commercial brain-computer interface. AstraZeneca is building new cell therapy centers in Shanghai. Astellas ended a T-cell engager pact with CytomX Therapeutics. And more.1. China approves first brain-computer interface implant for paralyzed patients, as sector heats upChina has granted the world’s first commercial approval to a brain-computer interface. The device, developed by Neuracle Technology in Shanghai, was cleared for people with paralysis to help them restore hand movements. The system includes implanted electrodes to record electrical activity in the brain, while the signals are transmitted to and decoded by a computer to control a robotic glove that can grasp objects. 2. AstraZeneca to build cell therapy manufacturing hub, R&D center in ShanghaiAstraZeneca aims to be the first multinational pharma to have end-to-end cell therapy capabilities in China. To do this, the company will establish a new commercial cell therapy manufacturing base and an innovation center dedicated to the modality in Shanghai. In addition, AZ is working with partners to launch a new life sciences collaboration initiative between Shanghai and the U.K.3. Astellas walks away from $1.6B biobucks T-cell engager pact with CytomX after 6 yearsAstellas has effectively ended a T-cell engager collaboration with CytomX Therapeutics six years after paying the Bay Area biotech $80 million upfront in a $1.6 billion biobucks deal. The Japanese pharma has chosen not to advance any preclinical assets using CytomX’s masked biologics platform. The move comes shortly after Astellas licensed a masked PSMAxCD3 bispecific from Vir Biotechnology.4. Sandoz expands biosim collab with Samsung Bioepis, sets sights on Takeda's EntyvioSandoz and Samsung Bioepis have expanded their biosimilar partnership to include up to five more products. The two firms are already partners on Samsung’s copycats of Johnson & Johnson’s Stelara and AstraZeneca’s Soliris. This time, they will initially work on a version of Takeda’s Entyvio. The deal has the potential to bring Sandoz’s biosimilar portfolio to 32 assets.5. Syneos Health scoops up Chinese CRO to secure place in ‘rapidly growing market’Syneos Health has acquired Chinese CRO Bestudy to capitalize on China’s growing biopharma sector. The local shop will continue operating as a standalone company, according to Syneos. Together, the two brands are “well positioned to support both global biopharma companies and emerging China-based innovators across clinical development,” a Syneos spokesperson said.6. Novo Nordisk’s semaglutide is about to go generic in India, China (The New York Times)Novo Nordisk’s patent on semaglutide will expire in India this Saturday. More than 40 Indian firms are expected to launch over 50 semaglutide products within weeks at discounts of at least 50% to 60%, according to Reuters. China could follow soon, as 10 generic competitors were in the final stage of evaluation by Chinese regulators in early March to market their semaglutide products. Other News of Note: 7. Celltrion signs up to $250M supply deal with unnamed global biopharma (release)8. Excalipoint Therapeutics launches with $68.7M to develop T-cell engagers (release)9. Daiichi Sankyo taps Leveragen's in vivo platforms for antibody discovery (release) 

Ovid adds $60M to study epilepsy drug in more indicationsSandoz, Samsung Bioepis expand biosimilar pactOvid adds $60M to study epilepsy drug in more indicationsOvid Therapeutics' stock jumped 14% on Wednesday after the company reported positive safety findings for OV329, a next-generation GABA-aminotransferase (GABA-AT) inhibitor being evaluated in a Phase I study for epilepsy. The results prompted the company to expand the candidate's development programme — and simultaneously raise the capital necessary for its broadened clinical plans. The biotech had previously reported biomarker data from the Phase I study showing that a 5-mg dose of OV329 increased GABAergic inhibition by 53% in one muscle group and 44.3% in another, as measured through transcranial magnetic stimulation. On Wednesday, Ovid said that in six patients who received a 7-mg dose of OV329, there were no treatment-related adverse events, supporting "a potential best-in-category profile." Ovid now plans to study OV329 in patients with tuberous sclerosis complex seizures and infantile spasms. To fund its clinical aspirations, the company on Wednesday priced a $60-million PIPE financing led by Point72. -Elizabeth EatonSandoz, Samsung Bioepis expand biosimilar pactSandoz is deepening its 2023 alliance with Samsung Bioepis with a new deal to develop and commercialise up to five biosimilars. The first programme, SB36, is currently in early-stage development as a biosimilar to Takeda's inflammatory bowel disease drug Entyvio (vedolizumab).Financial terms are being kept under wraps, but Samsung will handle development, regulatory filings in key markets and manufacturing, while Sandoz takes exclusive global commercialisation rights outside China, Hong Kong, Taiwan, Macau and the Republic of Korea.The agreement could increase Sandoz's biosimilar pipeline to as many as 32 assets. Earlier this month, the Novartis generics spinout said it was carving out a separate unit for its biosimilars business as it prepares for a wave of anticipated patent expirations over the next decade.-Anna Bratulic

Sandoz has inked a deal with Korean biosimilars specialist Samsung Bioepis to commercialize up to five copycats, including a knockoff of Takeda's Entyvio. Sandoz has struck a deal with Samsung Bioepis to partner on up to five biosimilars, with the first being SB36, a copycat of Takeda’s Entyvio (vedolizumab), which is being developed by the South Korea-based biosimilars specialist. Switzerland-based Sandoz gains the right to commercialize the biosimilars around the world, with Samsung Bioepis retaining commercial rights in China, Hong Kong, Taiwan, Macau and its home country. Samsung Bioepis will continue to develop, manufacture and handle the regulatory submissions for the biosimilars. Financial terms of the partnership were not disclosed.  The deal, which builds on the existing partnership of the companies, has the potential to expand Sandoz’s biosimilar portfolio to an “industry-leading” 32 assets, the company said in a release. The growing pipeline of products will allow Sandoz to capture a “significant share” of the $320 billion biosimilar loss-of-exclusivity market opportunity in the next decade, the company added.The companies initially got together in 2023, with Sandoz gaining commercial rights to Samsung’s Pyzchiva (ustekinumab), which is a knockoff of Johnson & Johnson’s Stelara. Sandoz launched it in Europe in July 2024 and in the U.S. in February 2025. Three months ago, the companies also paired up on Epysqli (eculizumab), which is Samsung’s biosimilar version of AstraZeneca’s Soliris.With the most recent agreement, analysts from Jefferies credited Sandoz’s “commercial infrastructure” as key to its ability to attract partners. They also noted that the Samsung Bioepis arrangement provides Sandoz with “improved long-term visibility on both R&D productivity and future launch cadence.” Samsung Bioepis plans to expand its biosimilar portfolio by 20 products by 2030, the company said two months ago at the J.P. Morgan Healthcare Conference. In addition to its Entyvio copycat, the company said it will develop biosimilar versions of Regeneron and Sanofi’s Dupixent, Johnson & Johnson’s Tremfya, Daiichi Sankyo and AZ’s Enhertu, Roche’s Ocrevus and Eli Lilly’s Taltz.As for Samsung and Sandoz’s plan to sell their Entyvio knockoff, Takeda has said its regulatory protection on the ulcerative colitis and Crohn’s disease treatment extends into May 2026. But some patents on the drug expire in 2032, according to the company's most recent annual report (PDF).“Any biosimilar that seeks to launch prior to 2032 would need to address potential infringement and/or the validity of all relevant patents and therefore the exact timing of biosimilar entry is uncertain,” the Japanese company explained in the report.For the last three quarters of 2025, Takeda reported Entyvio worldwide sales were up by 7% at 744.5 billion Japanese yen ($4.98 billion), with U.S. sales accounting for 494.8 billion Japanese yen ($3.03 billion).