Jubilant Generics Ltd.

Geopolitical tensions in China biotech dealmaking, new FDA approvals and a CDMO expansion by Fujifilm made our news this week. Geopolitical tensions are casting uncertainties over cross-border biotech deals. Johnson & Johnson and Legend Biotech's Carvykti, plus AstraZeneca and Daiichi Sankyo's Enhertu, secured new FDA approvals. Fujifilm is making a big investment in its facility in North Carolina. And more. 1. For Chinese biotechs, the out-licensing business is scorching hot. Could geopolitics rain on their parade? The proposed BIOSECURE Act has become an “elephant in the room” between potential cross-border partners in the U.S. and China, an international lawyer familiar with global business development transactions told Fierce. Drugs originating from China often took a so-called “China discount” in negotiations due in part to the “transactional administrative burden” of executing these transactions, the lawyer said. 2. With wider approval, J&J and Legend's Carvykti quickly leaps ahead of BMS' rival myeloma CAR-T Johnson & Johnson and Legend Biotech’s Carvykti has become the first BCMA-directed therapy for second-line treatment of multiple myeloma. The approval puts Carvykti one line ahead of its rival, Bristol Myers Squibb’s Abecma. As is the case with Abecma, Carvykti’s new label includes a new line in its boxed warning about the risk of secondary T-cell cancers. The FDA also expanded Carvykti’s manufacturing release specifications. 3. AstraZeneca, Daiichi Sankyo's Enhertu wins historic HER2 tumor-agnostic FDA nod AstraZeneca and Daiichi Sankyo’s Enhertu has become the first antibody-drug conjugate approved for a tumor-agnostic indication. The new nod allows the HER2 agent to be used in patients with HER2-positive solid tumors after prior systemic treatment or in those who have no other alternatives. The accelerated approval is based on tumor shrinkage data from three phase 2 trials. 4. Fujifilm Diosynth blueprints another $1.2B expansion at NC plant where it aims to employ 1,400 Fujifilm Diosynth Biotechnologies unveiled a $1.2 billion investment in its biomanufacturing facility in Holly Springs, North Carolina. With the project, the company hopes to seize on the expanding antibody-drug conjugate and bispecific antibody marketplace. The site’s cell culture facility will grow by 425,500 square feet and add eight 20,000-liter mammalian cell culture bioreactors. The Japanese CDMO expects the expansion will create 680 new jobs, increasing the total at the site to 1,400 by 2031. 4. Boehringer teams up with Sino Biopharm in broad oncology partnership in China (disclosure, PDF) Boehringer Ingelheim has entered into a strategic partnership with Sino Biopharm to bring the German company’s cancer drugs to China. The two will jointly develop and commercialize several prospects in Boehringer Ingelheim’s pipeline, including three clinical-stage assets. The drugs are brigimadlin, an MDM2-p53 antagonist that has advanced into the pivotal stage; zongertinib, a HER2 inhibitor with improved selectivity; and a DLL3xCD3 bispecific coded BI 764532. 5. FDA slams Jubilant Generics, Canada's Contract Pharmaceuticals with Form 483s The FDA has sent a four-observation Form 483 to Jubilant Generics after an inspection of the company’s plant in Bhagwanpur, India. Inspectors found workers at the facility failed to investigate and identify the root cause of the presence of out-of-specification drugs in a batch distributed in the U.S. Other lapses in record-keeping, timely completion of production and control procedures were found.   6. China’s D3 Bio rases $62M in new financing round led by Medicxi (release) After emerging with $200 million in 2020, China’s D3 Bio has completed a $62 million series A+ round led by Medicxi. The funding will be used to expedite the development of D3’s oncology pipeline, with a special focus on the global clinical trial of a KRAS G12C inhibitor coded D3S-001, which is currently in phase 2 development in non-small cell lung cancer, colorectal cancer and pancreatic cancer.

The FDA issued separate Form 483s to India’s Jubilant Generics and Contract Pharmaceuticals Limited Canada in the wake of inspections carried out in the last five months. India’s Jubilant Generics and Contract Pharmaceuticals Limited Canada were each hit with Form 483s by the FDA following inspections that uncovered questionable manufacturing practices. The Jubilant Generics inspection, which took place at the company’s production facility in Bhagwanpur, India, between Jan. 25 and Feb. 2 earlier this year, cited four observations, according to a letter posted April 5 on the U.S. regulatory agency’s website. Inspectors found the facility failed to investigate and identify the root cause of the presence of out-of-specification drugs in a batch of unspecified drugs that were later distributed in the U.S. after they were found in swab samples taken during a cleaning verification process, the FDA said. Additionally, the site’s quality control unit was cited for not keeping proper records or following written procedures after an inspector “observed the presence of at least three uncontrolled investigation documents in a locked bin that were placed for shredding.” The two other observations found the facility didn’t establish appropriate time limits for the completion of each production phase and failed to put control procedures in place that would validate the manufacturing processes. Separately, the agency issued a Form 483 to Contract Pharmaceuticals Limited in the wake of an inspection between Oct. 30 and Nov. 3, 2023, of its Mississauga facility located near Toronto. The FDA cited one observation. The company failed to “thoroughly review any unexplained discrepancy whether or not (a specific) batch has been already distributed.,” the agency said in a letter posted to its website April 3. A third-party contract lab found brucella melitensis, a highly pathogenic microorganism, during an environmental monitoring of the production area. When notified of its presence, however, the company didn’t initiate an incident report in order to conduct a documented investigation of the finding, the agency said.