On June 16, 2025 BioDlink reported that its self-developed Bevacizumab Injection (Pusintin) has received marketing approval from National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria (Press release, Tot Biopharm, JUN 16, 2025, View Source [SID1234653933]). This significant milestone accelerates BioDlink’s global expansion efforts, and reaffirms its R&D and commercialization strength in biosimilar—offering a high-value, accessible treatment option for cancer patients worldwide.

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Leveraging synergies with Kexing BioPharm, the global licensee for Pusintin in emerging markets, Pusintin has initiated regulatory filings in 35 countries. The approval in Nigeria not only marks the implementation of its global strategy but also signifies officially opening the door to the African market, bringing more affordable treatment alternatives to Nigerian patients.

ADDRESSING AFRICA’S GROWING HEALTHCARE NEEDS

Africa, with a population exceeding 1.5 billion (World Bank, 2024), faces increasing medical demand. Nigeria, as the "most populous country in Africa" (~220 million people), possesses both massive healthcare challenge and a major growth opportunity. According to the World Health Organization (WHO), Nigeria reports over 120,000 new cancer cases annually, growing at a rate of 5% per year—amid limited access to high-quality therapies. Pusintin’s approval meets this urgent medical need while serves as a model for expansion into other emerging-market.

INTERNATIONALLY RECOGNIZED MANUFACTURING & QUALITY EXCELLENCE

The approval has validated Pusintin’s compliance complies with international standards for R&D, manufacturing, and quality system. BioDlink’s production facilities have already passed GMP inspections in China, Japan, Brazil, Colombia, Egypt, Indonesia, and Argentina and also passed antibody drug and ADC EU QP inspection 4 times in past two years. BioDlink’s global-quality system ensures robust commercial supply, delivering more than 100 clinical projects with development, clinical filings, and manufacturing services worldwide, including European and the U.S. in the past 3 years.

This millstone marks the beginning of BioDlink’s international commercial rollout, injecting new momentum into its revenue diversification strategy and reinforcing its capabilities in global biosimilar commercialization.

BioDlink operates a large-scale, GMP-compliant biologics manufacturing facility, featuring four commercial lines with five drug substance production centers (including non-toxic conjugated drug substance units) and four drug production centers. Its world-class facilities and stringent quality system deliver reliable global supply for monoclonal antibodies (mAbs), bispecific antibodies, XDCs, and other biologics at global standards.

SUSTAINING GLOBAL MOMENTUM

BioDlink will continue collaborating with Kexing BioPharm to accelerate Pusintin’s approval in Southeast Asia and Latin America. Driven by a committed to innovation, quality, and global compliance, BioDlink will continue accelerating its expansion in overseas and emerging markets—bringing life-changing therapies to more patients worldwide.

On June 16, 2025 Pierre Fabre Laboratories reported the acquisition from Antares Therapeutics, Inc. ("Antares"), a spin-out of Scorpion Therapeutics, Inc., of the worldwide rights for PFL-721 and PFL-241 (formerly known as STX-721 and STX-241, respectively) (Press release, Pfizer, JUN 16, 2025, View Source [SID1234653932]). Under the terms of the agreement, Pierre Fabre Laboratories will expand its previous agreement with Scorpion Therapeutics to hold the global rights for both assets and will be leading the clinical development of both programs.

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PFL-721 is a mutant-specific EGFR exon 20 and HER2 exon 20 inhibitor, soon to transition to dose optimization within a first-in-human trial in NSCLC. PFL-241 is a mutant-specific, brain penetrant, 4th generation EGFR inhibitor, currently in dose escalation in a first-in-human trial, to address C797S resistance mutations in NSCLC patients.

NSCLC is the most common sub-type of lung cancer and various EGFR mutations are the most frequent drivers of NSCLC, occurring in approximately 14-38 percent of tumors, depending on geography.[1], [2], [3]

"With this agreement with Antares, Pierre Fabre Laboratories now own the global rights for all the assets within our R&D portfolio: exarafenib, PFL-002 (formerly VERT-002), PFL-721 and PFL-241. The R&D team is fully engaged and committed to progress the clinical development of these programs, aiming at providing novel and differentiated precision medicines to patient populations with significant unmet needs." said Francesco Hofmann, Head of Research and Development for Medical Care at Pierre Fabre Laboratories.

On June 16, 2025 AbbVie (NYSE: ABBV) reported the global Phase 3 VERONA trial evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of overall survival (OS) with a hazard ratio (HR) of 0.908; stratified log-rank, p=0.3772. No new safety signals were observed (Press release, AbbVie, JUN 16, 2025, View Source [SID1234653931]). Results from the VERONA trial will be available in a future medical congress and/or publication. Any patients who received venetoclax in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician.

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These data do not impact any current approved indications for venetoclax.

About the Phase 3 VERONA Trial
VERONA is a global Phase 3 randomized, controlled trial comparing the efficacy and safety of venetoclax in combination with azacitidine compared to azacitidine and placebo, in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (higher-risk MDS). The primary outcome measure is overall survival (OS). Key secondary outcome measures include modified overall response (mOR) and complete remission (CR).

More information can be found View Source

About VENCLEXTA/VENCLYXTO (venetoclax)
VENCLEXTA/VENCLYXTO (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA/VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.

VENCLEXTA (venetoclax) U.S. Uses and Important Safety Information 2

Uses

VENCLEXTA is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who:
‒ are 75 years of age or older, or
‒ have other medical conditions that prevent the use of standard chemotherapy.

It is not known if VENCLEXTA is safe and effective in children.

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?

Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

have kidney or liver problems.
have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
have a history of high uric acid levels in your blood or gout.
are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.
What should I avoid while taking VENCLEXTA?

You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.
Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. Globally, prescribing information varies; refer to the individual country product label for complete information.

On June 16, 2025 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", SSE: 600196, HKEX: 02196) reported that the companies, through their respective subsidiaries, have entered a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy (Press release, Teva, JUN 16, 2025, View Source [SID1234653929]). Teva’s internally developed ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications.

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Under the terms of the agreement, which aims to accelerate clinical data generation, Fosun Pharma is granted an exclusive license to develop, manufacture and commercialize TEV-56278 in Chinese mainland, Hong Kong Special Administrative Region (SAR), Macau SAR and Taiwan region and select Southeast Asian countries. Teva retains all development, manufacturing and commercialization rights to the licensed molecule in the rest of the world. The strategic partnership presents a significant step forward in the global development of TEV-56278, giving Teva the opportunity to leverage Fosun Pharma-generated data in other geographies.

"This partnership with Fosun Pharma in the development of our internally developed TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy with the potential to treat devastating cancers, is the latest advance to ensuring acceleration of our pipeline," said Eric Hughes, MD, PhD, Executive Vice President, Teva Global R&D and Chief Medical Officer. "TEV-56278 demonstrates the strength of Teva’s innovative drug development capabilities and how strategic partnerships with companies such as Fosun Pharma play a pivotal role in advancing therapies on behalf of patients."

Anti-PD1-IL2 fusion proteins like TEV-56278 represent a novel approach to cancer immunotherapy. TEV-56278 is designed to deliver IL-2 selectively to PD-1+ T cells, thus amplifying anti-tumor T-cell activity while minimizing off-target systemic toxicities. The targeted approach holds promise for improving outcomes for patients with a variety of oncology diseases.

"We are pleased to partner with Teva on the development of TEV-56278," said Xingli WANG, MD, PhD, Executive President of Fosun Pharma and CEO of the Global R&D Center, "This collaboration brings together Teva’s expertise in innovative drug development with Fosun Pharma’s strong oncology development experience and commercial capabilities in the China market, creating a powerful synergy to accelerate the delivery of this important therapy to patients globally."

About TEV-56278

TEV-56278 is an anti-PD-1 antibody-cytokine fusion protein designed to selectively deliver an interleukin-2 (IL-2), i.e., ATTENUKINE, to PD-1-expressing T cells within the tumor microenvironment. This targeted approach aims to amplify anti-tumor T-cell activity while minimizing systemic toxicities. TEV-56278 is being evaluated as a monotherapy and in combination with pembrolizumab. Preclinical data has demonstrated tumor regression, enhanced T-cell infiltration, and durable immune memory.

On June 16, 2025 Shasqi, Inc. ("Shasqi"), a biotech company whose mission is to make cancer drugs more effective with pre-targeting enabled by click chemistry, reported the publication of a manuscript detailing the preclinical development and translation of SQ3370 to a first-in-human dose-escalation clinical trial in patients with advanced solid tumors (Press release, Shasqi, JUN 16, 2025, View Source [SID1234653928]).

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The manuscript titled, Development of a first-in-class click chemistry-based cancer therapeutic, from preclinical evaluation to a first-in-human dose escalation clinical trial, was published today in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

"This groundbreaking clinical validation marks a paradigm shift in oncology—we’ve demonstrated for the first time that in vivo click chemistry can be used in humans to pre-target and concentrate therapeutics at tumor sites," said Dr. Sangeetha Srinivasan, Director of In-Vivo Biology at Shasqi. "By decoupling tumor targeting from the payload, our CAPAC platform enables delivery of 12-fold higher doses of doxorubicin per cycle compared to conventional approaches, while reducing systemic toxicity."

Shasqi’s Click Activated Protodrugs Against Cancer (CAPAC) platform is a pre-targeting technology composed of a tumor binding agent and a protodrug. Administered sequentially, these components are designed to only click with each other via a click chemistry reaction occurring directly at the tumor site. This releases high concentrations of cancer drugs at the tumor while sparing healthy tissues.

The manuscript describes the development and first-in-human study of SQ3370, an intratumorally injected biopolymer paired with a doxorubicin payload, and the first in vivo click chemistry based therapeutic to be tested in humans. In the study, 12x the standard dose of doxorubicin was administered per cycle with mild and manageable toxicities, including less than anticipated myelosuppression. The lack of immunosuppression and high drug doses enabled T-cell-dependent immune responses, including cytotoxic CD8 + T-cell expansion and activation in tumors and systemically.

"The significance of this work expands far beyond the current study, as it demonstrates that click chemistry can be harnessed inside the human body to redefine how therapeutics are activated in the body," said Carolyn Bertozzi, PhD, Professor of Chemistry at Stanford University, and winner of the Nobel Prize for Chemistry in 2022 for the development of click and biorthogonal chemistry. "This study shows that biorthogonal chemical groups and their reaction products are tolerated in humans, unlocking a new frontier for oncology innovation and beyond."

"This breakthrough study shows, for the first time, that click chemistry can be used inside the human body to activate cancer drugs at the tumor," said Jason S. Lewis, PhD, whose work as the Emily Tow Chair in Oncology and Deputy Director of Sloan Kettering Institute (OSET) at Memorial Sloan Kettering Cancer Center in New York is focused on pre-targeting radiopharmaceutical therapies using click chemistry. "This opens up new opportunities for targeted delivery of other cancer therapeutics such as radiopharmaceutical therapy."