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About

Zhejiang Hisun Chemical Co., Ltd (hereafter called as ”Hisun Chemical), founded in 1998, is a state-holding enterprise invested by State Development & Investment Corporation(SDIC), Zhejiang Hisun Group and ZMC Co., Ltd. The company now covers an area of 312,000 square meters and 35% of its staff members are technicians. With its total assets of nearly USD 60 million, Hisun Chemical has created a niche in agrochemical field through its sustainable researching, marketing efforts and strong distribution network. The company, with its headquarter located in Taizhou, Zhejiang, now has two wholly-owned subsidiary companies , two Sino-foreign joint ventures and one Provincial Hi-tech R&D Centre. Since it was established, Hisun Chemical has already passed ISO9000 & ISO14000 and gained lots of honors like “First AA-level Credit Enterprise of China Pesticide Industry” and “National Hi-tech Enterprise”, etc. Its product, Abamectin has also gained such awards as ”First Prize of S&T Advance Award of China Chemical Industry”, “Major Achievements in National Technologies R&D Program of the 8th Five-year plan of China” and “ Outstanding Project Award in National Technology Innovation Program of the 8th Five-year of China”. Meanwhile, Hisun Chemical has also undertaken the project of Emamectin Benzoate in National Key Technologies R&D program of the 9th Five-year plan of China. And Ascomycin, a kind of its biofungicides, has been listed in “National S&T Pillar Program of Technical Material Development in the 11th Five-year plan of China.” Based on full implement of EHS system and high quality product, Hisun Chemical has been one of the suppliers to many multinational companies, like Bayer, Syngenta, Boehringer Ingelheim and Cheminova, establishing long term business relationship with them. Hisun Chemical exports 85% of its products, ranging from Insecticides, Herbicides to Fungicides, directly to more than 50 countries over the world. Among those products, its patented products such as Oxine copper 33.5% SC & Flazasulfuron have obtained exclusive registration in China. Hisun Chemical adheres to “For Shareholders, For Staff, For Community” as its management purpose, “Honesty, Innovation, Collaboration& Diligence” as its core values, and “Broad Mind& Integrity” as its spirit. With advanced technology, and R&D, Hisun Chemical will strive to become a representative of Agrochemical, Pharmaceutical &Animal Health Field in the 21st century. Our Group-ZHEJIANG HISUN GROUP The original name of Hisun is HaiMen Pharmaceutical Company founded in 1956 and changed her name at 1997 to Zhejiang Hisun Group. Hisun is located in Taizhou, which is a scenic and coastal city at East Sea in China and is part of the southern tip of Shanghai Economic Zone. It contains 100 hectare area and there are more than 3000 employees. Hisun is ranked in the top 520 key enterprises in China, total asset of Hisun has reached RMB 1.6 billion, there is a national R&D center in Hisun and more than 30% of its staff are technician. Hisun has developed into the largest antibiotic and antineoplastic manufacturer and become a reputed one of main chemical production bases in China. There are three main subsidiary companies under Hisun Group which are Hisun pharmaceutical has been listed in SSE, Hisun Chemical and Hisun thermoelectricity. T products of Hisun have been approved and certified by FDA of U.S.A. meanwhile Hisun have got the approvals of ISO9001, ISO9002 and ISO14000. Hisun exports 80% of its products to approximately 100 countries all over the world, the products performance has been approved by domestic and international consumers.

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No.97 Waisha Road, Jiaojiang District, Taizhou, Zhejiang 318000

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INTERVIEW #SpeakPharma

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“Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient

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FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”, the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.

Impressions: 626

NEWS #PharmaBuzz

China's Zhejiang Hisun picks up new U.S. deal despite FDA troubles

11 Aug 2016

// Eric Palmer FIERCE PHARMA

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