Susan Haigney

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Bora Pharmaceuticals announced on Aug. 5, 2025 that it plans to invest in the expansion manufacturing and packaging capabilities at the company’s Maple Grove, Minn. facility that it acquired in 2024 with the acquisition of Upsher-Smith Laboratories. The expansion is part of the company’s growth to meet the demand for oral solid dose products, increasing complex formulations, novel drug delivery technologies, and the shift from solid dosage to biologic formulations.

The first phase of the contract development and manufacturing organization’s (CDMO’s) investment will be a Gerteis Macro-Pactor at the site that will be followed by a broader buildout of 100,000 square feet of dedicated shell space to streamline high-volume production. The FDA-inspected manufacturing site will have on-site quality control laboratories and a dedicated development team.

“With pharmaceutical companies relying more heavily on specialized CDMO partners to scale production and maintain quality, top-tier manufacturing capacity and technical expertise are at a premium,” said J.D. Mowery, president of Bora’s CDMO business, in a press release (1). “Bora’s Maple Grove facility offers a unique opportunity for innovators to secure space in a state-of-the-art site staffed by experts in formulation development, tech transfer, and commercial manufacturing.”

“As we complete our transition from Upsher-Smith, we’re creating the infrastructure to deliver integrated manufacturing, packaging, and analytical services with the speed and quality our clients need,” shared Dennis Hall, vice president and general manager of the Maple Grove site, in the release. “As we expand our capabilities, we look forward to tapping into all the experience and talent in the area.”

In July 2025, Bora announced the installation of a high-performance filling line at its Mississauga, Ontario, Canada manufacturing facility to expand the company’s production capabilities, especially for dermatologic products in response to projected growth in the dermatologic market. The new tube-filling line can produce approximately 7 million to 15 million units pers year and can handle metal, plastic, and ABL tubes. The line can accommodate fill volumes from 2g to 150g and supports scalability in manufacturing vessels, specifically for semi-solid manufacture, that range in size from 2.5Kg to 3600Kg. Laser printing capabilities are suited for dermatologic applications, and the line, which is PODA and Track and Trace serialization qualified, can pack tubes into a wide range of cartons, then bundle, and automatically pack into shipping cases.

“This filling line complements our deep expertise in semi-solid formulations and strengthens our ability to help customers scale up efficiently,” John Lawrie, vice-president of Operations for Bora Pharmaceuticals, said in a press release (2). “The upgrade significantly expands our capacity, allowing us to address growing demand for high volume production not just from our current partners, but from the marketplace as a whole.”

Bora Pharmaceuticals. Bora Pharmaceuticals Announces Multi-Year Expansion for Midwest Manufacturing Site, as Upsher-Smith Entity Split is Finalized. Press Release. Aug. 5, 2025. 

https://bora-corp.com/bora-pharmaceuticals-announces-multi-year-expansion-for-midwest-manufacturing-site-as-upsher-smith-entity-split-is-finalized/

Bora Pharmaceuticals. Cutting-Edge Technology to Accelerate High-Volume Production; Mississauga Site to be Outfitted with Tube Filler this July. Press Release. July 16, 2025. 

https://bora-corp.com/bora-pharmaceuticals-adds-new-filling-line-to-canadian-manufacturing-facility/

Articles

Bora Pharmaceuticals is expanding its manufacturing and packaging capabilities at its Maple Grove, Minnesota facility, acquired from Upsher-Smith Laboratories in 2024. This expansion aims to meet the growing demand for oral solid dose products and novel drug delivery technologies. The first phase includes installing a Gerteis Macro-Pactor and developing 100,000 square feet of production space. Additionally, Bora is enhancing its Mississauga, Ontario facility with a high-performance filling line to boost dermatologic product production. These expansions will support increased production capacity and technical expertise to meet market demands.

The investment will expand the company’s manufacturing and packaging capabilities at its Maple Grove, Minn. site, which Bora acquired in 2024 with its acquisition of Upsher-Smith Laboratories.

Bora Pharmaceuticals to Expand Midwest Manufacturing Site

ESTEVE CDMO (actively operating under the Esteve Química brand) announced on July 31, 2025 that it has acquired Regis Technologies, an API contract development and manufacturing organization (CDMO) in Chicago. The acquisition expands ESTEVE’s API contract development and manufacturing services in the United States from pre-clinical to commercial manufacturing.

ESTEVE CDMO, headquartered in Barcelona, is a global pure-play CDMO that specializes in small-molecule APIs, intermediates, spray drying technologies, and high-potency API manufacturing. To these services, Regis Technologies brings process R&D; analytical and stability; current good manufacturing practice (GMP) API manufacturing; chemistry, manufacturing, and controls support; and chromatography products.

"We are proud to strengthen our CDMO solutions for pharmaceutical innovators through this acquisition, while welcoming around 70 skilled professionals to our US team," said Joan Petit, chief industrial operations officer of ESTEVE and general manager of Esteve CDMO (Esteve Química), in a press release (1).

"This acquisition enhances our early-stage development capabilities, and expands our global manufacturing footprint, allowing us to have an integrated service offering to better respond to our customers' needs," Andrea Oro, global head of Commercial Operations and Strategy, added.

"We are happy to join a company that shares our same values, a company that is also family-owned, with more than 90 years of experience, that is committed to people and focused on delivering long-term value to customers," said Scott Aladeen, president and CEO of Regis Technologies, in the release.

ESTEVE acquires symptomatic medullary thyroid cancer treatment

In June 2025, ESTEVE, the company’s pharmaceutical development division, acquired the rights to Caprelsa (vandetanib) in more than 50 countries from Sanofi. Caprelsa (vandetanib) is a treatment for adults and children five years of age and above with aggressive symptomatic medullary thyroid cancer.

"Medullary thyroid carcinoma is a rare neuroendocrine tumor that can produce calcitonin from parafollicular cells. The treatment of resectable disease is surgery (2). When the disease is not technically resectable, this treatment provides a long-lasting slowdown of disease progression. We at ESTEVE are proud to join the fighting effort of the patients diagnosed with this carcinoma and their healthcare professionals, with the ambition to continue improving patient's health and lives," José María Giménez-Arnau, chief scientific & medical officer of ESTEVE, said in a press release (3).

Other recent acquisitions by the company include the purchase of a business specializing in rare and ultra-rare endocrinology and onco-endocrinology diseases in April 2024 and a license for a biologic treatment for children and adolescents aged 2–18 years old with severe primary insulin-like growth factor 1 deficiency in April 2025.

"We are proud to announce that we are increasing our portfolio of highly specialized therapies. Caprelsa will help us improve the lives of patients all around the world. This is a step forward in ESTEVE's international journey focused on highly specialized treatments for high unmet medical needs of patients," Jacob Tolstrup, chief commercial officer of ESTEVE, said in the press release (3).

ESTEVE CDMO. ESTEVE CDMO Acquires Regis Technologies, Expanding US Presence and Capabilities. Press Release. July 31, 2025. 

https://www.esteve.com/global/media/news/esteve-acquires-regis-technologies-expanding-u-s-presence-and-capabilities

American Thyroid Association. Cancer of the Thyroid. Thyroid.org (accessed Aug.6, 2025). 

https://www.thyroid.org/medullary-thyroid-cancer/

ESTEVE. ESTEVE to Acquire Medicine to Treat Medullary Thyroid Cancer. Press Release. June 30, 2025. 

https://www.esteve.com/global/media/news/esteve-to-acquire-medicine-to-treat-medullary-thyroid-cancer

ESTEVE CDMO, operating under the Esteve Química brand, has acquired Regis Technologies, enhancing its API contract development and manufacturing services in the US. This acquisition strengthens ESTEVE's capabilities from pre-clinical to commercial manufacturing, adding process R&D, GMP API manufacturing, and more. Additionally, ESTEVE's pharmaceutical division acquired Caprelsa (vandetanib) for treating aggressive symptomatic medullary thyroid cancer, expanding its portfolio of specialized therapies. These strategic moves align with ESTEVE's focus on highly specialized treatments for unmet medical needs, reinforcing its global presence and commitment to patient care.

The acquisition expands the CDMO’s small-molecule API development and manufacturing services in the US.

ESTEVE CDMO Acquires Regis Technologies

The Evolving Field of Radiopharmaceuticals

Radiopharmaceuticals have been traditionally used to treat superficial tumors, according to Mike Ritchie, CCO at 

. As they have evolved, they have been used to treat internal tumors, and now the technology is transforming to be directed specifically so that they only impact the tumor and not other cells in the body.

“There's so much [that goes] into pharmaceutical development into making something that can be manufactured at scale. It can sit on a shelf for a while. We can administer it to a patient, and it behaves in the way that we want,” says Ritchie. “We're just learning how to apply what we learn from anybody drug conjugatesinto radio drug conjugates, so the chemistry of how to link this radio ligand to an antibody, something that will continue to evolve, and there's a real opportunity there to improve that, to improve the therapeutic activity.From the biology perspective, again, we're in our infancy and understanding what are the tumor types, or the molecular cohorts within a tumor that are more sensitive to radio ligands. Like any chemotherapy or any therapy, certain tumors will respond. Others will not. They'll develop resistance. And so really understanding the right cohorts of patients to treat is something that we're still learning, and I think we'll continue to learn as the clinical development of these programs evolves.”

Click the video above to watch the interview.

Videos

Radiopharmaceuticals are moving from their standard use of treating superficial tumors into radio drug conjugates that target tumors without impacting other cells in the body.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

FDA announced on July 31, 2025, that it is requiring changes to the safety labeling of all opioid pain medications so that the risks associated with the long-term use of these types of drugs are emphasized and explained. This change comes after FDA reviewed data showing the serious risk of misuse, addiction, and overdose.

Data from two large FDA-required observational studies, postmarketing requirements (PMR) 3033-1 and 3033-2, provided new data on how long-term opioid use can lead to serious side effects. These data combined with public comments, medical research, and a lack of studies on the long-term effectiveness of opioids led the agency to require the safety labeling changes so that health care professionals and patients can make more informed treatment decisions.

Clearer risk information, including a summary of study results showing the estimated risks for addiction, misuse, and overdose during long-term use

Stronger warnings that higher doses come with greater risks that remain over time

The removal of language that may be misinterpreted to support using opioid pain drugs indefinitely

Guidance reinforcing that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate

A reminder that opioids should not be stopped suddenly in patients who may be physically dependent, to avoid serious harm

Additional information on drugs that can reverse an opioid overdose

Enhanced warning about combining opioids with other drugs that slow down the nervous system

New information about a serious brain condition that may occur after an overdose (toxic leukoencephalopathy)

Updates about opioid-related impacts on the esophagus.

Relevant drug manufacturers have 30 days to submit their labeling updates to FDA for review.The agency is also requiring an additional prospective, randomized, controlled clinical trial to examine the benefits and risks of long-term opioid use.

“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said FDA Commissioner Marty Makary, MD, MPH, in a press release (1). “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”

“I know firsthand how devastating addiction is—not just for individuals, but for entire families and communities,” said Health and Human Services Secretary Robert F. Kennedy, Jr., in the release. “Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”

 that 7-hydroxymitragynine (7-OH) products be classified under the Controlled Substance Act (2). A concentrated byproduct of the kratom plant, according to FDA, binds to opioid receptors and, therefore, has the potential for abuse. While there are no 7-OH drugs approved by FDA, the agency has stated that approximately 1.7 million Americans aged 12 and older have used products to self-treat pain, coughing, diarrhea, anxiety, and depression that are prepared from the leaves of Mitragyna speciosa, a tropical tree native to Southeast Asia (3).

Biopharma developers exploring kratom-based therapeutics are being urged to be cautious. Enhanced 7-OH products may raise concern over abuse liability and may face future regulatory scheduling, which could impact clinical research and investigational drug approval. The Drug Enforcement Administration, which has final scheduling authority, is reviewing FDA’s recommendation on 7-OH.

FDA. FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks. Press Release. July 31, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-requires-major-changes-opioid-pain-medication-labeling-emphasize-risks

FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers.

https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers

 FDA.gov, last updated July 29, 2025 (accessed July 30, 2025).

The FDA has mandated changes to the safety labeling of opioid pain medications to highlight the risks of long-term use, including addiction, misuse, and overdose. This decision follows data from observational studies and public input. The new labeling will include clearer risk information, stronger warnings, and guidance on opioid use. Additionally, the FDA is requiring a clinical trial to further assess long-term opioid use. The agency also recommended classifying 7-hydroxymitragynine products under the Controlled Substance Act due to their potential for abuse, impacting kratom-based therapeutic development.

The changes, required for safety labeling of all opioid drugs, will emphasize the risks with long-term use to combat misuse and addiction.

FDA Changes Opioid Pain Medication Labeling Requirements

Glass vials for liquid samples. | Image Credit: ©nordroden - stock.adobe.com

Personalized therapies have become a focus of the pharmaceutical industry with the advancement of cell and gene therapies, creating a need for specialized manufacturing processes and infrastructures. This new market of personalized treatments is also increasing the need for small batch sizes.

“Point-of-care production or hub-and-spoke models could become the norm,” David Phasey, Innovation Director at 3P innovation, said in an interview with 

® (1). “The automation of patient and manufacturing data will be key to this. The real question is whether the pharmaceutical industry is ready to adopt and accept this level of automation into a very slow-to-change industry. Can regulations keep up with technology and the opportunities it presents?”

Complexity often comes along with innovation. And the aspects of small-batch manufacturing for personalized medicine are no different. Processing speed, flexibility, and product yield are among these complex challenges.

“Every drop counts for high-value drugs, since even the slightest product loss has significant consequences related to the number of patients treated, as well as economic impacts, and must be avoided,” says Laura Moody, director of Product Management Pharma North America, Syntegon.

The challenges of small-batch manufacturing

Small-batch manufacturing comes with a distinct set of challenges, according to
Dr. Jitendra Amrutkar, Head–Process Technology & Support, ACG Engineering. Small batch means fewer doses and, therefore, a high cost per unit, Amrutkar adds, and these costs can be reduced by using modular systems and single-use technologies. The frequent changeover of products can also hit costs by creating downtime.

“There is clearly a trend toward smaller batch sizes of sterile product,” says Hanns-Christian Mahler, CEO, ten23 health. “This, of course, raises key questions on ‘yield’, as maximizing yield translates directly into the cost-of-goods for a given product. This is particularly important for such costly APIs as biologics.”

The manufacturing facility and processes must be adequately designed for small batches, stresses Mahler. “Specifically, ready-to-use (RTU) containers are convenient to avoid the need for large washing machines or sterilizing tunnels. However, formulation development and stability data are required to allow selection of an RTU container a priori,” he states.

There are also unique complexity considerations with personalized treatments, such as specialized materials and unique regulatory approvals, according to Dr. Amrutkar. “AI [artificial intelligence] and blockchain can help to overcome this issue by improving visibility and coordination,” he offers as a solution to supply chain concerns. For regulatory compliance issues, he recommends using digital records and adaptive pathways.

Automation has been an increasing tool for pharmaceutical manufacturing, but Dr. Amrutkar cautions that traditional automation systems are not suited for small batches. He recommends smart, modular automation and cobots, which offer flexibility.

A variety of process development approaches can help with the challenges of small-batch manufacturing, according to Dr. Amrutkar. He points to modular process design for flexible, scalable setups of products to support faster changeover and reduced downtime. A modular design may also make expansion easier. Virtual testing of processes before they are implemented can be facilitated by digital twins and simulation, Dr. Amrutkar says, which can reduce risk and improve efficiency. Continuous manufacturing can also streamline production by causing fewer interruptions and increasing turnaround times. Lastly, optimal process conditions can be identified by utilizing design of experiments.

“On the process side, suitable processing materials, such as tubing and filters, help to maximize extraction of the product,” Mahler explains. “Pharmaceutical manufacturers must consider ‘flush volumes’ that are required for the setup (e.g., to saturate sterile filters); how much volume other in-process controls (IPCs) require; and how the sampling volume may be reduced. Understanding the scale and batch size capabilities of a facility, including the lowest compounding volume that can be used, are key considerations.”

The evolution of human-centered to fully automated production in aseptic filling is increasing, according to Moody, with the use of “robotics for container transfer, fill/finish operations, and format part exchange within the isolator. A shift to gloveless systems further reduces the need for manual intervention,” she says.

“To avoid product loss, 100% IPC during the filling process ensures that almost every drop of product is filled,” Moody continues. “Moreover, new small- or even micro-batch solutions can support scale-up from manual clinical trial operations to automated production scale.”

Isolators and restricted access barrier systems can provide high contamination control and cost-efficiency for small-batch manufacturing by ensuring sterility in aseptic environments, says Dr. Amrutkar. To minimize product loss and ensure dosing accuracy, he points to micro fillers that can provide precision filling for low-volume, high-value biologics. Digital management of manufacturing and batch records can be achieved through manufacturing execution systems and electronic batch records. “They improve traceability, compliance, and data integrity, which is especially important for personalized medicine,” Dr. Amrutkar says. In addition, “ACG’s capsule filling and inspection systems are high-precision systems tailored for clinical and personalized applications. They are tailored for low-volume needs with integrated inspection to ensure quality assurance,” Amrutkar offers.

Flexible filling platforms are available for small- and micro-batch operations. Syntegon offers platforms that can process between 120 and 500 containers per hour and batches up to 3600 containers per hour. The company’s Versynta microBatch platform is a fully automated gloveless production cell with integrated air handling that was developed in partnership with Vetter, according to Moody.

ten23 uses ready-to-use (RTU) containers to operate at different sterile filling scales. In July 2025, the company announced it had joined the “Alliance for RTU” partnership, which intends to advance knowledge around sterile manufacture of RTU containers. The company’s role will be to contribute its own experience in development, sterile fill/finish, and testing of sterile drug products using RTU containers (2).

When it comes to fill/finish of small batches, scale related to unit operations needs to be appropriate, says Mahler, who says manufacturers should consider the following questions. “How do you mix and homogenize 1 liter of material for a commercial product? Is that in place? Which disposables do you use, and how can you minimize residual volumes on the line? Where and why do you pull samples for in-process testing or extended characterization, and how can these volumes be reduced?”

He adds, “One great example is the choice of adequate sterile filters: some filter materials tend to adsorb critical components of a biologics formulation and may require 1 or more liters of flush volume. Other filters will be saturated with 10 mL. That can be a huge cost driver, or saver.”

Targeted solutions can address challenges associated with the fill/finish of small batches, says Dr. Amrutkar. For sterility assurance, isolators and automated aseptic systems are key for managing contamination risk, he says.

Safeguarding the aseptic environment is key in fill/finish of small batches of biopharmaceutical products, Moody agrees. “Humans pose the greatest risk for product contamination, so operator intervention must be reduced to an absolute minimum or even completely avoided to reduce this risk,” she says. Annex 1 of the European Union’s good manufacturing practice guidelines (3) recommends the use of these barrier technologies.

Precision filling technologies and single-use systems can combat product loss. Adopting a risk-based digital validation approach can streamline repeated validation.

Fill/finish systems that are traditionally used in pharmaceutical manufacturing are often too large for filling small batches of product. Scaling down to miniaturized, single-use equipment can combat this, according to Amrutkar.

Small batches of products may require different container formats that complicate the setup of machines. “Implementing modular lines and quick-change tools can help simplify the process, increase flexibility and adaptability, and help eliminate bottlenecks,” Amrutkar says.

Small-batch manufacturing should be performed holistically with development, manufacturing, and testing approaches integrated, says Mahler, and the combination of formulation and primary packing should be done ‘wisely.’

“Think about potential failure modes and assess your process in development labs, assessing the choice of materials, failure modes and acceptable ranges for your operating parameters, to ensure there is no (relevant) impact on your product’s critical quality attributes,” Mahler concludes.

Haigney, S. New Modalities in Biopharmaceutical Development Transform Industry. 

Lavery, P. ten23 health Joins Gerresheimer, SCHOTT, Stevanato Group in ‘Alliance for RTU’. 

EC. Annex 1: Manufacture of Sterile Medicinal Products. 

®
Vol. 49, No. 6
July/August 2025
Pages: 16–17

When referring to this article, please cite it as Haigney, S. Flexibility Provides Solutions to Small-Batch Manufacturing Challenges. 

Advancements in cell and gene therapies have driven the pharmaceutical industry towards personalized treatments, necessitating specialized manufacturing processes and infrastructures. Small-batch manufacturing presents challenges such as high costs, processing speed, and product yield. Modular systems, single-use technologies, and automation are proposed solutions to these challenges. The use of AI, blockchain, and digital records can enhance regulatory compliance and supply chain coordination. Flexible filling platforms, precision filling technologies, and modular lines are essential for efficient small-batch production, ensuring sterility and minimizing product loss.

Modular process design, single-use technologies, and flexible filling lines are some of the ways manufacturers can combat challenges involved in small-batch manufacturing.

Flexibility Provides Solutions to Small-Batch Manufacturing Challenges

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

GSK announced on July 28, 2025, that it has entered into agreements with Hengrui Pharma to develop treatments for respiratory, immunology, and inflammation conditions, and new therapies for GSK’s oncology pipeline. The agreement includes a license for a potential best-in-class PDE3/4 inhibitor for the treatment of chronic obstructive pulmonary disease (COPD) and 11 programs that Hengrui Pharma will develop, and GSK will option, following Phase I completion.

New COPD maintenance treatment part of the agreement

The exclusive worldwide license (excluding mainland China, Hong Kong, Macau, and Taiwan) for Hengrui’s COPD treatment, HRS-9821, gives GSK the potential to add a convenient dry-powder formulation to the company’s inhaled medicine portfolio. HRS-9821, according to GSK, is in development as an add-on maintenance treatment for COPD and has demonstrated potent PDE3 and PDE4 inhibition in early clinical and preclinical studies. The license to HRS-9821 is dependent on applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the United States.

“The addition of HRS-9821 supports GSK’s ambition to treat patients across the widest spectrum of COPD by including those who face continued dyspnea (shortness of breath) or who are unlikely to receive inhaled corticosteroids or biologics, based on their disease profile,” the company stated in a press release (1).

Other potential treatments in development

The other 11 programs included in the collaboration will have their development led by Hengrui Pharma to completion of Phase I trials, including patients outside of China. GSK will then have the option to further develop and commercialize the programs worldwide (excluding mainland China, Hong Kong, Macau, and Taiwan) and certain program substitution rights.

"We're delighted to announce these exciting agreements with Hengrui Pharma which complement our already-extensive pipeline,” Tony Wood, chief scientific officer, GSK said in the press release. “This deal reflects our strategic investment in programs that address validated targets, increasing the likelihood of success, and with the option to advance those assets with the greatest potential for patient impact.”

"This strategic collaboration with GSK marks yet another significant milestone in Hengrui’s globalization journey and our mission to innovate and deliver higher-quality, cutting-edge therapies for patients worldwide,” Frank Jiang, executive vice president and chief strategy officer of Hengrui Pharma, said in the release. “GSK brings additional R&D expertise, a robust global clinical network, and broad regulatory capabilities that will accelerate our PDE3/4 inhibitor as well as an array of other innovative therapy programs to overseas markets, potentially delivering breakthrough treatments to patients globally."

Upfront fees totaling $500 million across the agreements will be paid by GSK to Hengrui Pharma as part of the deal. If all programs are optioned by GSK and all milestones are achieved, Hengrui Pharma could potentially receive up to approximately $12 billion as part of the collaboration.

In other recent GSK news, on July 17, 2025, FDA approved the company’s prefilled syringe version of Shingrix recombinant zoster vaccine used to prevent shingles (2). The previous formulation required clinicians to combine a lyophilized antigen with a liquid adjuvant. The version features easier preparation and reduces risk of handling errors.

“The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration,” Brigid Groves, vice president of professional affairs at the American Pharmacists Association, said at the time in a press release (2). “FDA approval is a positive step toward driving prevention of this painful disease, and as a practicing pharmacist I welcome the availability of this new presentation.”

GSK. GSK and Hengrui Pharma Enter Agreements to Develop Up to 12 Innovative Medicines Across Respiratory, Immunology & Inflammation, and Oncology. Press Release. July 28, 2025. 

https://www.gsk.com/en-gb/media/press-releases/gsk-and-hengrui-pharma-enter-agreements/

US FDA Approves GSK’s Shingrix in a Prefilled Syringe Presentation. Press Release

GSK has partnered with Hengrui Pharma to develop treatments for respiratory, immunology, inflammation, and oncology conditions. The collaboration includes a license for a potential best-in-class PDE3/4 inhibitor for COPD and 11 programs that Hengrui will develop through Phase I, with GSK having the option to further develop them. The agreement involves upfront fees of $500 million, with potential earnings for Hengrui up to $12 billion. Additionally, GSK's Shingrix vaccine received FDA approval for a prefilled syringe version, simplifying administration and reducing handling errors.

The two companies have entered into an agreement to develop respiratory, immunology, inflammation, and cancer therapies.