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Consultant, New York, with Simon-Kucher & Partners’ life sciences division

The importance of a strategic approach and proper due diligence in unlocking the full potential of these arrangements.

Navigating Cross-Border Pharma Deals: Key Trends and Lessons Out of China 

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

The past few years have been a roller coaster ride for M&A in pharma and biotech. After the highs of the pandemic came crashing down, 2024 saw interest return to this sector in the industry. Subin Baral, global life sciences deals leader at EY, spoke with 

 about the past year in M&A and what 2025 potentially holds.

Pharmaceutical Executive: How significant an issue is pricing and access to drugs and medical devices?


 In general there is a steady trend towards need for more clinical and even real-world evidence to validate pricing levels and win reimbursement, and the provisions of the Inflation Reduction Act in the US have pushed drug pricing in particular up the agenda. The IRA provisions make it more difficult to evaluate portfolio assets, since they may be affected in the near future by tightening restrictions on price for a particular drug class or therapeutic class, and this is a challenge for dealmakers. Within the industry there is some expectation that the new administration in the US may relax or remove the IRA provisions, which would potentially help unleash M&A in 2025 and beyond.

PE: How big of an impact is digital transformation expected to have?


 Digital transformation has been held back by lack of investment at scale in the life sciences, but we are seeing technologies begin to win validation, with AI at the forefront. We saw a record 87 deals targeting AI technology in 2024, including Recursion’s deal to merge with Exscientia, probably the biggest pure AI deal in the life sciences space to date. We have particularly seen a focus on R&D, with 87% of AI dealmaking in the sector focused on using AI to improve R&D efficiency. Bending the cost curve on drug development would be a huge result for the industry, but in fact there are opportunities for AI, and other digital technologies, across the life sciences value chain. To make digital transformation work, however, life sciences companies need to learn how to work most effectively with tech partners, which means setting expectations correctly, and understanding the differences in workflow, mindset and culture more generally, all key themes in successful partnering.

PE: What trends have been identified in R&D within the Pharma industry?


 Oncology continues to be the biggest focus for Pharma dealmaking, since the relentless innovation in that field has made it the biggest and the highest-growth therapeutic area. However, we are also seeing a resurgence in R&D in the immunology and CNS fields, among others, which have attracted dealmaking spend in the past two years. GLP-1, and other next-generation anti-obesity medicines, have also been a huge breakthrough, and the scale of the clinical and commercial opportunities from anti-obesity R&D are drawing many companies into this space. The other over-arching key trend is the move towards more complex modalities, including antibody-drug conjugates (ADCs), next-generation radiopharmaceuticals, and cell and gene therapies. One interesting development is the emergence of Chinese R&D as an important target for dealmakers–innovative Chinese biotechs have attracted greatly increased alliance funding from Big Pharma players, with ADCs and oncology therapies in general the major focus.

PE: How are evolving customer expectations influencing strategy?


 This is one of the biggest areas where we can expect digital technology and AI to make a big difference to strategy in the long term. With the amount of data available in health care today, from genetic data through behavioral data and all the other personal information captured in the digital footprint, we have the tools for health care to potentially become far more personalized and pro-active, and to bring to care delivery the quality of user experience we expect in other areas of life, from retail to travel. However, this involves using data and technology more effectively and at greater scale than the industry does at present. In MedTech we already have many “smart devices” that can capture user data at levels never seen before–the challenge is to use that data to improve the experience for the user herself, and that’s a challenge the industry will be able to tackle in a more digital, less analog future.

The EY executive discusses trends in this sector and what he expects to see in the coming year.

The Present and Future of M&A: Q&A with Subin Baral

Teva Pharmaceuticals announced two strategic collaborations to expand its biosimilar portfolio and enhance access to high-cost biologics across key markets.

The first deal, which is with Formycon AG and Klinge Biopharma, aims to commercialize FYB203, a biosimilar to Eylea (aflibercept), in most European countries and Israel. According to Teva, the collaboration will combine its commercial expertise in the biosimilar space with Formycon’s experience in developing these medications in highly regulated countries. Currently, Klinge maintains exclusive global commercialization rights to FYB203. Pending regulatory approval, Teva will market the product under the name Ahzantive for severe retinal diseases.

"We are excited to extend our collaboration with Formycon, reinforcing the solid foundation that commenced with the commercialization of ranibizumab biosimilar (Ranivisio/Ongavia) in Europe. The collaboration expands Teva’s broad biosimilar portfolio and again demonstrates our firm commitment to creating greater access to quality innovative medicines to the benefit of patients and the healthcare systems we serve,” said Richard Daniell, EVP, European commercial, Teva, in a press release.

Under terms of the deal, Teva will spearhead commercialization efforts in the specified region, with Klinge receiving milestone payments as well as a percentage of the treatment’s revenue.

FYB203 was first approved by the FDA in June 2024. The European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive recommendation for the marketing authorization of FYB203 in November 2024. A final European Commission decision is expected by the end of the month.

“With Teva, we are gaining a strong and proven partner for FYB203 in the major parts of Europe and Israel. Teva is already marketing our FYB201 ranibizumab biosimilar (Ranivisio/Ongavia) in Europe and can synergistically leverage an existing commercial infrastructure and well-established distribution channels in the ophthalmology field. We are pleased to build on this trusted and successful collaboration. Particularly noteworthy is Formycon’s first-time responsibility for managing the entire commercial supply chain of the finished product,” said Nicola Mikulcik, chief business officer, Formycon, in the press release.

Teva also recently announced a collaboration with Samsung Bioepis for the commercialization of Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab) for the treatment of rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome, and generalized myasthenia gravis (gMG). Epysqli was first approved by the FDA last July in patients with PNH. In November 2024, it was granted approval to treat gMG in adults who are anti-acetylcholine receptor antibody positive. The treatment is also currently approved in Europe and South Korea.

“We are excited to announce this new strategic partnership for a biosimilar which has a significant potential to increase access for rare disease patients, who are suffering from the high-cost and the limited availability of the treatment. Rare diseases such as PNH, aHUS and gMG, pose many but unique challenges to patients and their families, and we are dedicated to enhancing the lives of patients including those with rare diseases,” said Kyung-Ah Kim, president, CEO, Samsung Bioepis, in a press release. “This collaboration is a testament of our long-term commitment in the biosimilars business, as a leading biopharmaceutical company with a mission to innovate access to treatments for healthcare systems, payers, providers, and patients. We will work closely with Teva to accelerate access to this important biologic medicine for rare disease patients in the US.”

Under terms of the deal, Samsung Bioepis will lead development regulatory registration, manufacture, and supply, while Teva will work on commercialization efforts in the United States. Financial terms are currently being kept confidential.

“We are excited to enter this partnership with Samsung Bioepis, who share our commitment to accelerate the delivery of impactful and accessible medicines to patients. The collaboration enables us to leverage our extensive commercial capabilities and is aligned with our Pivot to Growth strategy, introducing a new biosimilar to our broad biosimilar portfolio, accelerating access to affordable treatment options,” said Chris Fox, EVP, US commercial, Teva, in the press release.

1. Teva Announces Collaboration to Commercialize Formycon’s Biosimilar Candidate to Eylea® (aflibercept) in major parts of Europe and in Israel. 

January 13, 2025. Accessed January 14, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-collaboration-to-commercialize-formycons-biosimilar-candidate-to-eylea-aflibercept-in-/

2. Teva and Samsung Bioepis Enter into a Strategic Partnership for Commercialization of EPYSQLI® (eculizumab-aagh) in the United States. 

January 10, 2025. Accessed January 14, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-and-samsung-bioepis-enter-into-a-strategic-partnership-for-commercialization-of-epysqli-eculizumab/

New partnerships aim to expand Teva’s biosimilar portfolio and enhance access to high-cost biologics across key markets.

Teva Agrees to Strategic Partnerships with Formycon AG, Klinge Biopharma, & Samsung Bioepis

I was asked recently to share my thoughts on the rise of Chinese biotech out-licensing deals and to predict what may happen next. Ahead, I summarize emerging market trends impacting China's biotech sector and outline a potential roadmap for the industry in the near future.

What has happened to the Chinese biotech innovation society?

For many years, China has been the second-largest pharmaceutical market in the world, trailing only the US market. China is now considered the second-largest drug innovation market in the world, next to the US.

There have been three main stages in which Chinese biotech has evolved, all of which have been broadly acknowledged.

: Before 2010, China’s pharmaceutical market was dominated by generic drugs, with international companies having significant influence over the entire market. Few Chinese biotech companies were in the market.

From 2010 to 2020, there was a significant transformation toward an innovation-driven ecosystem, from generics to novel drugs. More Chinese biotech startups appeared.

 Since 2020, the Chinese biotech sector has experienced a notable trend toward developing first-in-class treatments, leading to a rapid increase in licensing transactions.

Why has there  been a sudden influx of out-licensing deals occurring?

The nature of the market determines the form of business. Thirty years ago, when international companies first entered the Chinese market, they chose joint-venture cooperation with local companies due to a lack of understanding of the market. Twenty years ago, those international companies moved to give up joint ventures in favor of wholly owned businesses in China to enjoy 100% of the profits. Five to six years ago, a trend emerged in which international pharma companies either left the Chinese market or shifted their strategies due to changes in policy and the competitive environment.

The following principles also explain why Chinese biotech companies choose to out-license their R&D pipelines, which is one of the few options they have for surviving and growing in the current market.

The global shortage of innovative drugs, patent cliffs, and the pressing need for improved therapies to cure diseases, especially in biology.

This is a global issue, where we are at a stage of fading efficiency and effectiveness of last-generation medicines. Yet, a new generation of medicine is on the horizon, but has not yet fully matured. We’re in a gap age. Pharma companies are seeking next-generation therapies, especially those facing patent expirations for their notable originator products.

 Recognition of Chinese biopharma companies' R&D capabilities by international organizations is also one of the key drivers.

Thirty years ago, China lacked sufficient high-quality researchers for drug development. Today, however, the profiles of the founding teams of Chinese biotech companies contrast that sentiment. Many are well-educated at renowned universities and research institutes across the world and have years of experience in the research departments of international pharmaceutical companies, with some even hailing from those organizations' core research teams. There are no general communication barriers; they speak the same language in science and share a mutual understanding of the development vision. Hence, their research works are recognized by peers as assets in paving the way to a transaction.

 Lack of fundraising channels to complete development works.

Although China has the second-largest capital market in the world, it is much smaller and less flexible than the US capital market, particularly in the biotech sector. For example, the downside of the macro economy results in reduced investment in early-stage biotech companies. The suspension of IPO approval lessens the chances of biotech startups seeking funds from the public market. Biotech companies are forced to license out some of their assets to support their pipeline developments.

 High pricing power and strong go-to-market capabilities by international companies lead to the greater success of the pipeline.

The pricing space in international markets such as the US and the EU is larger than that in the Chinese market. As a result, Chinese biotech companies going global are likely to achieve higher investment returns. By leveraging their existing sales networks, drug registration teams, and marketing capabilities, and considering that there is, basically, not a single global pharma company from China, it seems that this is an easy way to gain a global return without global operations.

What will possibly happen in the near future?

This licensing business model between Chinese companies and international companies will last for some time. However, a trend is emerging in which Chinese biotech startups are pursuing IPOs in either the Hong Kong or US capital markets. Eventually more biotech companies, whether publicly listed or privately owned, will be acquired by international firms. Therefore, in the next few years, we can expect an increase in M&A deals in the Chinese biotech sector.

At some point, large Chinese pharmaceutical companies will join the bid to acquire R&D pipelines or take over the entire business. This will increase the valuation of Chinese biotech startups, and more funds from Chinese private equities will flow into this sector.

Adam Zhang Yu is the founder & CEO of Collabrium Partners

A surge in biotech startup out-licensing deals from the country are paving the way for increased IPO and M&A activities.

Exploring Biopharma's Dealmaking Terrain, Roadmap in China

Sen-Jam Pharmaceutical announced that it has received an investment from 5 Horizons Capital to advance a Phase II clinical trial for SJP-001, a novel therapy for inflammation and metabolic health. The trial, which was developed in collaboration with Novotech, will evaluate SJP-001’s potential to improve metabolic health, specifically targeting dietary and alcohol-induced overindulgence. Additionally, the partnership is expected to combine Sen-Jam’s technology, Novotech’s expertise in early phase clinical trials, and 5 Horizons’ financial and strategic resources to accelerate the therapeutic’s development, the companies stated in a press release.

"We are thrilled to welcome 5 Horizons Capital as a financial and strategic partner to our team, on our journey to revolutionize inflammation care. Their investment and expertise in advancing clinical-stage therapies will enable us to bring SJP-001 closer to patients worldwide. With Novotech's excellence in trial management and 5 Horizons' visionary support, we are one step closer to transforming how the world addresses metabolic health and inflammation,” said Jim Iversen, co-founder, CEO, Sen-Jam Pharmaceutical, in a press release.

A pilot study sought to determine the effects of SJP-001 on alcohol hangover severity. Thirteen healthy social drinkers participated in the double-blind, factorial design, crossover study, with each participant consuming their preferred amount of alcohol sufficient enough to report a hangover on a daily basis. Each morning, hangover severity was assessed with the Acute Hangover Scale (AHS).

Results found that SJP-001 significantly improved the AHS overall hangover severity score compared to placebo. Additionally, the treatment demonstrated improvements on hangover scores; however, the observed improvement didn’t reach clinical significance. The treatment improved scores for symptoms such as tiredness, thirst, headache, dizziness, nausea, and loss of appetite, but these also didn’t reach statistical significance.

"As the lead investor in Sen-Jam's Phase 2 clinical trial for SJP-001, we are proud to be part of this community that has the potential to redefine how inflammation is treated globally. We are committed to supporting this groundbreaking therapeutic as it moves into clinical trials. Additionally, we look forward to collaborating with other investors to drive follow-on funding and accelerate the development of this promising asset,” said Aaron Ray, managing director, 5 Horizons Capital, in the press release.

1. Sen-Jam Pharmaceutical Secures Financial and Strategic Investment from 5 Horizons Capital to Advance SJP-001 Clinical Trial with Novotech. 

January 22, 2025. Accessed January 22, 2025. https://www.prnewswire.com/news-releases/sen-jam-pharmaceutical-secures-financial-and-strategic-investment-from-5-horizons-capital-to-advance-sjp-001-clinical-trial-with-novotech-302357405.html

2. The Effects of SJP-001 on Alcohol Hangover Severity: A Pilot Study. 

Accessed January 22, 2025. https://pubmed.ncbi.nlm.nih.gov/32244274/

The trial, developed in collaboration with Novotech, will specifically target dietary and alcohol-induced overindulgence.

Sen-Jam Partners Strikes Deal with 5 Horizons Capital to Support Phase II Trial of SJP-001 for Inflammation, Metabolic Health 

ImmunityBio has entered a collaboration and supply agreement with BeiGene to conduct a confirmatory Phase III trial to evaluate the combination of tislelizumab, BeiGene’s PD-1 checkpoint inhibitor (CPI), and ImmunityBio’s Anktiva (nogapendekin alfa inbakicept-pmln) in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have developed a resistance to CPIs. According to ImmunityBio, the trial will be guided by data from the QUILT 3.055 study, which indicated that Anktiva can restore T-cell function and improve overall survival (OS) in CPI-resistant patients.

“The challenge oncologists face in the next five years is how to manage the many patients who do not respond to CPI therapy after an initial response,” said Patrick Soon-Shiong, founder, executive chairman, global chief scientific and medical officer, ImmunityBio, im a press release. “Currently, options are limited for these second- and third-line patients with NSCLC whose cancer continues to progress on CPIs. The finding that these ‘cold’ tumors, which have evaded T cells, can now be rendered ‘hot’ through the activation of natural killer cells with Anktiva is exciting. To our knowledge, Anktiva is the first approved cytokine to address low white cell count (lymphopenia), which occurs following chemo-immunotherapy and radiotherapy. On the basis of Anktiva’s mechanism of action of proliferating T cells as well as NK cells, Anktiva has the potential to serve as the foundational cytokine to address loss of activity in the multiple tumors in which CPIs are approved.”

The ResQ201A-NSCLC trial is expected to enroll approximately 462 patients across multiple sites globally. The trial’s primary endpoint is OS, with key secondary endpoints that include disease control rate, progression-free survival, objective response rate, and safety.

According to ImmunityBio, Phase I and II data suggest that approach extends median OS beyond historical chemotherapy results, with QUILT 3.055 reporting a median OS of 14.1 months. Additionally, the combination of Anktiva and tislelizumab demonstrated a median OS of 17.1 months in patients with PD-L1 ≥ 50%, while patients who relapsed on checkpoint inhibitor therapy demonstrated a median OS of 19.6 months.

Statistics from the American Cancer Society indicate that approximately 226,650 people will be diagnosed with lung cancer in the United States this year, with approximately 124,730 deaths. Lung cancer mainly occurs in older people, with a median diagnosis age of 70 years. However, a small number of people can be diagnosed under 45 years of age. Despite being the second most common cancer in the Unites States, it is the leading cause of cancer-related deaths, accounting for more fatalities than colon, breast, and prostate cancers combined. In men, only prostate cancer is more common while in women, only breast cancer is more common.

Men have a one in 17 chance of developing lung cancer. On the other hand, women have a one in 18 chance, including both smokers and non-smokers.

“ImmunityBio and BeiGene share a similar vision to advance the next generation of oncology immunotherapies to address unmet needs. We are excited to explore the potential of our PD-1 inhibitor, tislelizumab, in combination with Anktiva,” said John V. Oyler, co-founder, chairman, CEO, BeiGene, in the press release. “I’ve admired Dr. Soon-Shiong’s bold approach to medicine and look forward to working with him and his team as the ResQ201A-NSCLC study gets underway. Together, we hope to help metastatic lung cancer patients who may have few options left.”

1. ImmunityBio Announces Collaboration with BeiGene on Confirmatory Phase 3 Trial of ANKTIVA® and PD-1 Checkpoint Inhibitor Combination in Non-Small Cell Lung Cancer. 

January 29, 2025. Accessed January 30, 2025. https://immunitybio.com/immunitybio-announces-collaboration-with-beigene-on-confirmatory-phase-3-trial-of-anktiva-and-pd-1-checkpoint-inhibitor-combination-in-non-small-cell-lung-cancer/

Accessed January 30, 2025. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html

The Phase III trial builds on findings from prior findings that indicated Anktiva can restore T-cell function and improve overall survival in patients with advanced of metastatic non-small cell lung cancer who are PD-1 checkpoint inhibitor resistant. 

Joki Wallace

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