Simcere Zaiming Pharmaceutical Co., Ltd.

GSK, Roche and Novartis continued Big Pharma's dealmaking spree with Asian companies. Three mid-sized Asian biopharmas reached “most favored nation” deals with the White House. Akeso and Summit Therapeutics' ivonescimab delivered a head-to-head overall survival win against Keytruda. And more. 1. GSK pens $1.3B Hutchmed deal for early-stage KRAS-EGFR cancer asset In a deal potentially worth nearly $1.3 billion, GSK is paying Hutchmed $110 million up front to license an antibody-targeted therapy conjugate. The preclinical candidate, coded HMPL-A830, attaches a KRAS inhibitor payload to an anti-EGFR antibody. Clinical development will initially focus on colorectal, pancreatic and lung cancers, with a phase 1 expected to start this year. 2. Roche inks $1.53B deal for Simcere’s B-cell-targeting antibody Roche will gain exclusive global rights to a preclinical trispecific antibody targeting CD79a, CD19 and CD3 from Simcere Zaiming. The deal, up to $1.53 billion, features a $75 million upfront payment. The drug’s mechanism holds potential across B-cell-mediated diseases, including in patients pretreated with CD20- or CD19-directed therapies, according to Simcere. 3. Genentech doubles down on ADC-resistant cancers with $1B DualityBio pact Roche’s Genentech has signed a platform deal to utilize DualityBio’s Dupac antibody-drug conjugate platform. The platform has produced multiple payloads, which are designed to retain efficacy in tumors that progress on topoisomerase-based ADCs. The deal includes a $45 million upfront payment and could be worth more than $1 billion in milestones payments. 4. White House unveils next round of MFN pricing deals with 9 midsized drugmakers Astellas, Kyowa Kirin and Sun Pharma are among nine midsized biopharmas to have signed “most favored nation” drug pricing deals with the Trump administration this week. Besides lowering prices for Medicaid, Astellas will donate 25 kg of tacrolimus active pharmaceutical ingredient to the U.S. strategic reserve. Kyowa highlighted that its agreement includes the deferral of Section 232 tariffs. 5. Akeso, Summit’s ivonescimab extends lives in Keytruda head-to-head trial. What now? The Chinese Harmoni-2 trial, which first sparked hopes that Akeso’s ivonescimab—and the PD-1xVEGF class by extension—could replace Keytruda, has met its overall survival endpoint in first-line PD-L1-positive non-small cell lung cancer. However, with attention circling Summit Therapeutics’ global Harmoni-3 trial, reception to the new topline readout was tepid. 6. Novartis inks $3.2B subcutaneous drug delivery deal with Alteogen Novartis has struck a potential $3.2 billion option and license deal to develop subcutaneous products utilizing Alteogen’s ALT-B4, the same recombinant human hyaluronidase that Merck & Co. uses for its subcutaneous version of Keytruda. AstraZeneca, Biogen and GSK are also among the South Korean company’s customers. 7. Takeda bolsters blood cancer portfolio with FDA nod for Mimrylo in polycythemia vera Takeda won FDA approval for Mimrylo, or rusfertide, for the rare blood cancer polycythemia vera. It’s the first drug for PV that mimics hepcidin, a hormone that regulates iron in the body, to control overproduction of red blood cells, a hallmark of the disorder. Mimrylo is among three launches that Takeda’s new CEO, Julie Kim, is counting on to drive future growth. 8. Why Roche is 'really excited' about a UCN2 analog for obesity after seeing preclinical data 9. FDA leaders telegraph tightened foreign clinical data oversight (FDA Voices) 10. Patient died in Immunofoco's China IIT trial for CLDN18.2 CAR-T (The Beijing News, Chinese) 11. AZ, Hutchmed combo hits ph.3 goal in first-line lung cancer subtype (release) 12. Alumis crushed by midstage lupus flop but plots path to phase 3 for TYK2 inhibitor 13. FDA dings Alar over ‘extremely concerning’ ketamine claims

Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in President Donald Trump’s Most Favored Nation drug pricing scheme. > Listen on Spotify > Listen on Apple Products > Listen on Amazon Music > Listen on iHeart > Watch on YouTube The biggest news of the week belongs to Novartis , which paused several trials of its CAR T candidate rapcabtagene autoleucel in autoimmune disease after the deaths of three patients taking the therapy. Bristol Myers Squibb followed suit, voluntarily freezing autoimmune trials for its own CAR T asset zolacabtagene autoleucel after observing “transient and reversible inflammatory events,” the company told William Blair, which broke the story. On a more upbeat note, Revolution Medicines secured early FDA approval for a groundbreaking pancreatic cancer drug, now dubbed Rasonque. The greenlight is a big win not only for patients with the relentless and deadly disease, but also for the product’s chances in other indications, including first-line pancreatic cancer and non-small cell lung cancer. Truist Securities in a note last week went as far as to say that RevMed “remains on course to emerge as the next oncology titan .” Unfortunately, the news wasn’t all positive in the cancer space last week. BioNTech discontinued a Phase 2 trial of its personalized mRNA cancer immunotherapy autogene cevumeran in colorectal cancer after an Independent Data Safety Monitoring Board determined that continuation would be futile. This almost immediately follows Merck & Moderna’s positive Phase 3 readout in melanoma last month—part of an overall resurgence for mRNA. In other clinical trial struggles, AstraZeneca and Ionis’ Wainua failed more spectacularly in a Phase 3 trial in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) than originally reported . Detailed data revealed last week showed the hazard ratio in the trial was 1.14—meaning that patients had a 14% higher rate of cardiovascular mortality and recurrent clinical events versus the comparator arm. Meanwhile, on the business front, nine midsize biopharma companies —including Astellas Pharma, BeOne Medicines and BridgeBio—have joined President Donald Trump’s Most Favored Nation drug pricing scheme, pledging to bring down the prices of their products to the same level as in similarly developed countries. And finally, deals continue to soar as Eli Lilly picks up new therapeutic candidates for autoimmune and allergic diseases and Roche finds another oncology gem in Asia, inking an up to $1.5 billion partnership with China’s Simcere Zaiming.

Roche is paying oncology-focused Simcere Zaiming $75 million upfront for global rights to a preclinical trispecific antibody targeting B-cell-mediated diseases. Under the deal, Roche will gain exclusive global rights to develop, manufacture and commercialize the asset, SIM0660. Simcere Zaiming is eligible to receive up to $1.53 billion in total payments, including the upfront fee, as well as tiered royalties of up to double digits on future net sales, according to the release . "This agreement with Simcere Zaiming reflects our commitment to partnering with innovative companies to advance and deliver new therapeutic options for patients in need. SIM0660 represents a potential advancement for patients with B-cell-mediated diseases," Boris L. Zaïtra, Roche head of corporate business development, said in the release. SIM0660 is a preclinical trispecific antibody designed to target CD79a, CD19 and CD3. The molecule combines a CD3-engaging arm that binds to T cells with domains that target the B-cell antigens CD79a and CD19. The approach is designed to trigger T cell-mediated killing of target cells while limiting cytokine release, according to Simcere. The dual targeting of CD79a and CD19 could give SIM0660 therapeutic potential across B-cell-mediated diseases, including in patients previously treated with CD20- or CD19-directed therapies. Simcere also sees potential for the antibody in B-cell-mediated autoimmune diseases. Simcere Zaiming was founded in 2023 as an oncology-focused subsidiary of Simcere Pharmaceutical Group, which dates back to 1995. The Chinese biopharma previously partnered with G1 Therapeutics to sell Cosela , a therapy designed to reduce chemotherapy-induced bone marrow damage, in China, Hong Kong, Macau and Taiwan. Simcere also markets the biliary tract cancer treatment Enweida in China. Simcere has also turned its pipeline into a steady source of biobucks. The pharmaceutical group has now completed six out-licensing transactions worth a potential aggregate total of more than $6.1 billion, according to the company. Those deals included AbbVie’s $1.05 billion biobucks pact for Simcere’s phase 1 trispecific T-cell engager SIM0500, NextCure’s $745 million deal for ex-China rights to the phase 1-stage antibody-drug conjugate SIM0505 and Ipsen’s $1.06 billion pact for the preclinical ADC SIM0613. Then, in January 2026, Boehringer Ingelheim penned a 1.05 billion euro ($1.26 billion) biobucks deal for Simcere’s preclinical inflammatory bowel disease bispecific antibody SIM0709. The deal handed Boehringer global rights outside Greater China. Simcere spinout Simnova has been busy, too. The cell therapy biotech said Aug. 31 that it had closed a nearly 400 million yuan series B financing to advance its off-the-shelf CAR-NK and in vivo CAR-T programs. Simnova spun out of Simcere in 2021 after being established in Cambridge, Massachusetts, in 2019. The Simcere pact is Roche’s second sizable licensing deal in just over a week. On Aug. 24, the Swiss pharma put down a $190 million upfront payment for a clinical-stage UCN2, or urocortin-2, analog from South Korea’s Hanmi Pharmaceutical. That deal is worth up to about $2.5 billion in total.