Lilly Invests $3 Billion to Expand U.S. Manufacturing; GSK Extends Shingrix Exclusive Distribution Deal with Zhifei Biological; AstraZeneca’s Imfinzi Receives FDA Approval for Limited-Stage SCLC

Enterprise Dynamics

Eli Lilly and Company announces $3 billion investment to expand recently acquired Wisconsin plant, with construction expected to begin next year。This move will help meet the growing demand for injectable drugs such as Mounjaro and Zepbound. Lilly's plan will bring its total investment in Wisconsin to $4 billion. The expanded facility will add 750 high-skilled jobs to the area, including operators, technicians, engineers, and scientists. An additional 2,000 jobs will be created during the construction phase.

Teva Pharmaceutical Industries Ltd.(Teva Pharmaceutical Industries) to Spin Off Japanese Joint Venture with Takeda PharmaceuticalTeva Pharmaceutical Industries announced that it has reached an agreement with JKI, a company established by a fund managed and operated by J-Will, to transfer all shares of its Japanese joint venture with Takeda Pharmaceutical to JKI. Teva expects the divestiture to be completed by April 1, 2025, and all employees of the Japanese joint venture will continue to be employed.Takeda Pharmaceutical also announced the sale of its 49% stake in a joint venture with Teva Pharmaceutical Industries for 55 billion yen.。

Global Blood Giant Haemonetics Agrees to Sell Whole Blood Assets to GVS S.p.A.。GVS, a manufacturer specializing in providing filtration solutions for healthcare and life sciences, has a total cash consideration for this transaction of up to $67.1 million, including an upfront payment of $44.6 million and contingent earn-out payments of up to $22.5 million over the next four years. The transaction is expected to be completed in the first quarter of 2025.

Neuralink, the brain-computer interface company founded by Musk, is under federal investigation for alleged violations of the U.S. Animal Welfare Act.The reason is that internal employees of the company complained that its animal experiments were carried out hastily, and there might be behaviors such as animal abuse. This federal investigation was initiated by the USDA Inspector General at the request of federal prosecutors. Executives of Neuralink have publicly stated that the company only tests on animals after exhausting other research options.

Swedish biotech company Alligator Bioscience announces it will lay off 70% of its employees as part of a comprehensive strategic reassessment initiative.After the layoffs, the company will reduce its workforce to 15 full-time employees. The layoffs, which still need to be negotiated with the union, will mainly affect employees working in discovery and other non-clinical positions. Alligator expects the restructuring to reduce its operating costs by approximately $5.9 million annually.

ProBio announced that Allen GUO will be appointed as Chief Executive Officer (CEO) effective December 1, 2024.Whitney Winters as Senior Vice President of U.S. Business Development, and Michael Vreeland as Head of the U.S. Plant and Interim Head of U.S. Process Development. In addition, Chen Li, former CEO of Probio, will continue to serve as an advisor to ensure a smooth transition for the company.

Industry Dynamics

GSK and Zhifei Biological Products have reached an agreement to revise the terms of the Exclusive Distribution and Co-Promotion Agreement signed by both parties in October last year.According to the agreement, GSK exclusively supplies Zhifei Biological with the recombinant shingles vaccine and grants Zhifei Biological the rights to market, promote, import, and distribute the relevant products within the agreed cooperation region. The revised agreement extends the original three-year term (2024 to 2026) by eight years to 2034 and adjusts the expected sales volume. Zhifei Biological also agrees to exclusively collaborate with GSK to explore potential cooperation for commercializing the respiratory syncytial virus (RSV) vaccine Arexvy in mainland China, with an initial cooperation period of 10 years, subject to regulatory approval of the vaccine.

AstraZeneca Announces FDA Approval in the U.S. for New Indication of PD-L1 Monoclonal Antibody Durvalumab (Imfinzi), for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after concurrent platinum-based chemotherapy and radiation therapy, becoming the first and only immunotherapy regimen targeting LS-SCLC. Imfinzi, a key immunotherapy from AstraZeneca, has been approved in multiple countries for the treatment of various types of lung cancer and is the global standard therapy for patients with stage III unresectable NSCLC who have no disease progression after chemoradiotherapy.

Contract Development and Manufacturing Organization (CDMO)Cambrex Announces Agreement with Lilly to Provide Accelerated Clinical Development Capabilities for Lilly's Biotechnology DivisionThrough this agreement, Cambrex will collaborate with Lilly's early external innovation and collaboration unit, Lilly Catalyze360-ExploR&D, to provide active pharmaceutical ingredients, drug products, analytical service laboratories, and R&D expertise to Lilly Catalyze360 biotechnology partners.

Merus's Bizengri (Zenocutuzumab) Biologics License Application (BLA) Approved by U.S. FDA for Market Launch, for the treatment of neuroregulin 1 fusion (NRG1+) non-small cell lung cancer (NSCLC) and NRG1+ pancreatic ductal adenocarcinoma (PDAC) patients. Zenocutuzumab is not only the world's first approved HER2×HER3 bispecific antibody, but also the first FDA-approved therapy specifically targeting NRG1+ advanced unresectable or metastatic PDAC and NSCLC. Neuroregulin 1 (NRG1) is a ligand that binds to human epidermal growth factor receptor (HER) 3, promoting HER2/HER3 heterodimerization and oncogenic activity, leading to tumor growth.

Official website of the National Medical Products Administration announcementFosun Pharma's wholly-owned subsidiary, Shenyang Hongqi Pharmaceutical Co., Ltd., has officially received approval for its Prinptomani tablets.Pretomanid, a new molecular entity drug developed by the Global Alliance for TB Drug Development (TB Alliance), was approved by the U.S. FDA in 2019 for use in combination with bedaquiline and linezolid to treat specific patients with highly drug-resistant pulmonary tuberculosis.

DualityBio Announces First Data from Global Phase I/IIa Clinical Trial (NCT05914116, CTR20232835) of DB-1311/BNT324 (Innovative ADC Molecule Targeting B7H3).The results showed that DB-1311/BNT324 demonstrated encouraging anti-tumor activity and manageable safety in patients with locally advanced/metastatic solid tumors who had previously received multiple lines of treatment. DB-1311/BNT324 is jointly developed by DualityBio and BioNTech.

Alamar Biosciences Announces Latest Progress in Its Global Expansion: The first ARGOT HT system in the Asia-Pacific region has been installed at the Hong Kong Centre for Neurodegenerative Diseases (HKCeND), an advanced ultra-sensitive proteomics platform. The combination of the ARGOT HT system and NULISA technology aims to revolutionize biomarker discovery by enabling scientists to better detect and quantify proteins with its sensitivity and accuracy.

Cordyceps Sunshine Biotech Holdings Co., Ltd. [C.S Group] Announces Official Entry into the New Drug Field of Antrodia CamphorataThe key component extracted from the bull camphor tree—Antcin A—will be used as the main raw material to create an external ointment. Initial plans are to target the global pet steroid medication market.

Following companies such as Takeda, Pfizer, UCB, and WuXi AppTec,GSK announces it will exit the Biotechnology Innovation Organization (BIO) in 2025.GSK Spokesperson States: After Annual Review of Corporate Membership and Industry Association Involvement, the Company Chooses Not to Renew BIO Membership for 2025. The Biotechnology Innovation Organization (BIO), the largest trade association for biotech companies globally, currently lists companies such as AstraZeneca, Bayer, Eisai, Eli Lilly, GSK, and Amgen among its members. Since December last year, several large pharmaceutical companies have announced their withdrawal from BIO.

A latest study published in The Lancet shows that, after more than 50 years, researchers have found a new method for treating asthma and chronic obstructive pulmonary disease (COPD).Researchers found that, compared to the current steroid tablet treatment, injecting benralizumab into asthma and COPD patients is a more effective treatment method and can also reduce the frequency or need for subsequent treatments.Benralizumab, an anti-inflammatory drug developed by AstraZeneca, can directly, rapidly, and nearly completely deplete eosinophils within 24 hours to reduce lung inflammation.

Source: PharmaHealth News

Author: Su Ding