Suzhou Suncadia Biopharmaceuticals Co., Ltd.

FDA's citations for Hengrui, Sanofi's $437 million expansion in India, and closure of the Singapore biotech Aslan made our news this week. A 10-page Form 483 has detailed the shortfalls at Hengrui Pharma's PD-1 plant behind a recent FDA rejection. Sanofi is investing heavily to expand its global capacity center in India. Singapore biotech Aslan Pharma is winding down. And more. 1. Behind Hengrui's surprise FDA rejection: Scathing Form 483 lists litany of shortfalls at PD-1 drug plant The Form 483 that led to the FDA’s rejection of Jiangsu Hengrui Pharma and Elevar Therapeutics’ PD-1 inhibitor camrelizumab included 10 observations issued to Hengrui’s subsidiary, Suzhou Suncadia Biopharmaceuticals. In addition, the FDA has upgraded a prior eight-observation Form 483 into a warning letter for Hengrui’s small-molecule facility in Lianyungang, China. 2. Sanofi to more than double its workforce at Hyderabad site with $437M expansion: reports Sanofi will invest 400 million euros through the end of the decade to expand its global capacity center in Hyderabad, India. Sanofi plans to grow the site’s workforce to 2,600 people—from 1,000 today—in two years, making it the largest of the company’s four global capacity hubs. The site will grow its digital capabilities, including utilizing artificial intelligence tools. 3. Aslan’s dream of challenging Dupixent dies as cash-strapped biotech winds down Aslan Pharmaceuticals, one of the first Singapore-based biotechs to rise to the global stage, is shutting down. With $18.4 million in cash as of the end of March, the company has decided to file for liquidation and has let go all its staffers. The biotech’s stock price was once worth nearly $390 a piece at its peak in 2018 until its lead program, the pan-HER drug varlitinib, failed. Before the decision to close doors, Aslan received a delisting warning from Nasdaq as its stock price had been trading below the $1 bid price. 4. J&J’s CAR-T partner Legend Biotech reportedly receives buyout offer Legend Biotech reportedly received a takeover bid and has tapped Centerview Partners as a financial adviser, according to StreetInsider. The stock price surged for Legend and its former parent and largest shareholder, GenScript. The report came a few weeks after two House lawmakers had requested an intelligence briefing on GenScript and its related operations, including Legend. 5. SK inks $572M deal for Full-Life prospect, advancing push to become Asia’s radiopharma leader SK Biopharmaceuticals inked a $571.5 million biobucks deal to license an NTSR1-directed radionuclide-drug conjugate candidate, FL-091, from Full-Life Technologies. NTSR1 is overexpressed in colorectal, breast, pancreatic, and head and neck cancers. The Korean company outlined plans a year ago to expand in oncology and identified radiopharmaceuticals as one of the modalities driving the push. Other News of Note: 6. Sotio taps Biocytogen to create bispecific ADCs in $326M deal 7. Aveo spins a silver lining in failed trial of kidney cancer drug Fotivda 8. BeiGene brings on Merck veteran as new CFO (release)

Hengrui Pharma facilities in China have received three Form 483s and a warning letter from the FDA in less than a year. A lengthy Form 483 from the FDA listed a range of concerns that led to the agency’s surprise rejection of Jiangsu Hengrui Pharma and Elevar Therapeutics’ PD-1 inhibitor camrelizumab in May.  The 10-page, 10-observation document was issued to Suzhou Suncadia Biopharmaceuticals, a wholly owned subsidiary of Hengrui, in December 2023 following a two-week inspection of the company’s facility in Suzhou, China, according to a copy of the document (PDF) recently obtained by Fierce Pharma. Problems uncovered by FDA inspectors included a lack of control over equipment systems meant to protect data integrity, an absence of established procedures to prevent microbiological contamination of sterile drug products, insufficient visual inspections before product releases, failures to implement appropriate controls to ensure product standards, plus potential mix-ups between raw materials meant for the Chinese and U.S. markets. Deficiencies at the Suncadia plant were the main reason behind the FDA’s rejection of the monoclonal antibody camrelizumab and the small-molecule VEGFR inhibitor rivoceranib as a combination regimen for newly diagnosed liver cancer. Following the citation, Hengrui provided a “very long, comprehensive” response to the FDA, Elevar CEO Saeho Chong, Ph.D., told Fierce Pharma during an interview last week. According to Chong, the FDA’s drug review team told the two companies that it was satisfied with Hengrui’s response during a meeting earlier this month. The FDA also encouraged Hengrui to refile its application, and the two companies are now targeting resubmissions around the end of September or October. But to enable an approval, a separate FDA inspection team will still need to clear the plant, and that may involve reinspecting the facility, Chong said. The breadth of the manufacturing problems uncovered by the FDA is surprising considering Suncadia has been producing camrelizumab for the Chinese market since 2019. The drug has been approved in China in nine indications, including as a first-line liver cancer treatment with rivoceranib, also known as apatinib, since January 2023. In 2021 alone, Hengrui said it produced nearly 2 million bottles of camrelizumab. The company stopped separating the drug’s performance in its financial reporting from 2022 onward as competition in China’s PD-1/L1 market heated up. In a securities filing published last week, Hengrui said the Suncadia site passed a manufacturing inspection conducted by Chinese authorities between May 29 and June 1.   FDA observations FDA inspectors, for their part, flagged multiple specific examples of production shortfalls. In one case related to potential threats to data integrity, the FDA noted that manufacturing operations staffers used an “admin” account, which should be controlled by IT for critical manufacturing computer systems, to make certain product batches following a computer incident. In another case, a purity analysis data integration was conducted manually without adequate instructions to ensure accuracy, even though an automatic reporting system existed. At a different point, FDA noted that certain forms for production and control records could be replaced without being easily detected. As for potential contamination threats, the FDA zeroed in on human activities, or “high-risk interventions,” in close proximity to the aseptic area, which need to be performed with care because they can introduce contamination. The FDA was worried that some parts of the working area were not decontaminated properly after such operations. Further, the FDA said the Hengrui site didn’t have proper procedures in place to prevent microbiological contamination of sterile drug products. Again, the FDA meticulously pointed out details such as whether a new side of a sanitizing wipe was used during a cleaning. What’s more, the FDA dinged the Hengrui facility for not implementing sufficient controls “to ensure that drug products conform to appropriate standards of identity, strength, quality and purity.” The agency raised three past batch deviations to make its point. In one case, Hengrui didn’t perform a retrospective analysis of a leak during the production of a batch to understand the potential impacts on the sterility of previously made batches. Although camrelizumab would mark the first opportunity for the Suncadia biologics unit to supply medicines for the U.S. market, Hengrui already has U.S. market experience on the small-molecule side of its production business. However, the Chinese pharma giant’s manufacturing capabilities have been called into question lately—beyond simply the camrelizumab situation.   Warning letter in Lianyungang The FDA just escalated a prior eight-observation Form 483 into a warning letter for Hengrui’s small-molecule finished drugs facility in the Chinese city of Lianyungang. The agency issued the warning letter last week after deeming Hengrui’s March response to the site's Form 483 inadequate. At the top of the FDA’s list of concerns was an observation that the Lianyungang facility lacked adequate data oversight. As the FDA sees it, the plant’s quality assurance (QA) department simply was not functional. During an inspection in January, FDA staffers spotted discarded records, as well as a “production manager’s unrestricted access to blank production batch records” and other documents, according to the warning letter. Further, employees were able to fill out new records and discard old ones with no assurance that the data were original or accurate, the FDA noted. In its response, Hengrui said it would reassess its document management software to require better controls. The firm created new procedures for document destruction and trained its employees with it. But the FDA said Hengrui’s remedies didn’t include a comprehensive assessment into employees creating new records, nor did the company identify the root cause or scope of the data shortfalls. The data integrity problem appeared to be so serious that the FDA offered a long list of suggestions. The agency urged Hengrui to investigate the extent of these inaccuracies, to conduct a risk assessment of the potential effect, and to implement corrective and preventative plans. The FDA also criticized the Lianyungang facility over inadequate physical separation of working areas, which may compromise the sterility of drugs. Despite Hengrui’s commitment to provide better protections, the FDA suggested that the company work on a comprehensive risk assessment of all contamination hazards and a detailed remediation plan. In a statement to Fierce Pharma, Hengrui said it will respond to the FDA’s letter as requested and is fully committed to addressing the agency’s concerns. “[A]fter a comprehensive investigation and evaluation, we have determined the issues raised in the warning letter have not affected the quality or safety of the products manufactured at this site,” Hengrui said. The Lianyungang facility, located on Huanghe Road, is responsible for making 12 generics for the U.S. market, according to local media outlet Yicai (Chinese). In 2023, those U.S. exports contributed about $12.4 million in revenue, or about 0.39% of Hengrui’s total haul, according to Yicai. The warning letter does not affect the export of those drugs, Hengrui said. “As always, patient safety is our top priority, and we work to ensure the highest levels of regulatory compliance across our global network of manufacturing sites,” the company added.   Dongjin Road plant shortfalls  To add to the company’s list of headaches, the FDA in August issued a separate Form 483 to another Hengrui facility located on Dongjin Road in Lianyungang. Hengrui has altogether four manufacturing facilities in its hometown of Lianyungang. That letter flagged nine observations, according to a copy (PDF) obtained by Fierce Pharma. Among the deficiencies, the FDA found that some samples taken for specification measurements were not properly representative of their batches and that lab controls lacked good testing procedures. The agency also flagged deficient systems or procedures for maintaining equipment to control aseptic conditions, for monitoring environmental conditions, and for preventing microbiological contamination, among other problems Both the Huanghe Road and Dongjin Road facilities produce apatinib for the Chinese market. Editor's Note: The story has been updated with additional comments from Hengrui.

The Lupus Nephritis market is anticipated to show positive growth owing to factors such as increasing prevalence, strong pipeline activity, and the presence of multiple Large-Cap Pharma players. LAS VEGAS, June 6, 2022 /PRNewswire/ -- DelveInsight's Lupus Nephritis Market Insights report proffers a detailed comprehension of the lupus nephritis market size by treatment, epidemiology, emerging therapies, lupus nephritis market share of the individual therapies, current and forecasted lupus nephritis market size from 2019 to 2032 segmented into 7MM (the United States, EU5 [Germany, France, Italy, Spain, and the United Kingdom], and Japan). Some of the salient features from the Lupus Nephritis Market report: As per DelveInsight's analysis, the total lupus nephritis market in the 7MM is expected to grow at a CAGR of 8.4% during the study period 2019-2032. Key companies currently working in the market include names such as Aurinia Pharmaceuticals, Roche, AstraZeneca, Boehringer Ingelheim, Novartis, Novartis Pharmaceuticals, Hoffmann-La Roche, Janssen Research & Development, BeiGene, Suzhou Suncadia Biopharmaceuticals Co., Ltd., Alexion Pharmaceuticals, Omeros Corporation, Corestem, Inc., Bristol-Myers Squibb, Boehringer Ingelheim, Apellis Pharmaceuticals, AstraZeneca, Kezar Life Sciences, Equillium, Eledon Pharmaceuticals, Resolve Therapeutics, and others. The lupus nephritis pipeline therapies include GAZYVA, Saphnelo (Anifrolumab), Iscalimab, Cosentyx, Zanubrutinib, Ravulizumab, Anifrolumab, Itolizumab, and others that are expected to launch in the upcoming years. As per our estimates, the total lupus nephritis market size in the United States accounted for USD 975.1 million in 2021, which is likely to rise during the study period. For further information on market impact by therapies, download the lupus nephritis market sample @ lupus nephritis therapeutic market landscape Overview Lupus Nephritis is a common and potentially devastating exhibitionof systemic lupus erythematosus. It is a leading cause of morbidity and mortality in patients with SLE. LN leads to inflammation of small blood vessels which play an essential role in filtering waste materials in the kidney. It also involves the inflammation of glomeruli. Common lupus nephritis signs include hematuria, proteinuria, edema, and sudden weight gain. It is vital that patients with lupus have routine urine analysis with microscopy looking for protein, blood, and cellular casts. Lupus nephritis is primarily caused by the deposition of immune complexes. The size of the complexes determines the deposition location, which leads to differences in classification. There are five types of lupus nephritis. Treatment is based on the type of lupus nephritis, determined by the biopsy. Since symptoms and severity vary from person to person, treatments are individually tailored to meet a person's particular circumstances. Lupus Nephritis Epidemiology Segmentation According to DelveInsight's analysis, the total diagnosed cases of lupus nephritis in the 7MM were approximately 209k cases in 2021 that are anticipated to increase by 2032. The lupus nephritis market report offers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into- Prevalent population of lupus nephritis Total diagnosed population of lupus nephritis Gender-specific prevalent population of lupus nephritis Class-Specific cases of lupus nephritis Clinical manifestations of lupus nephritis Learn more about the lupus nephritis population trends for the 7MM by downloading @ lupus nephritis epidemiological forecast report The lupus nephritis treatment landscape currently has some approved therapies, while the principal goal of the present treatment regimen is to normalize renal function or, at least, prevent the progressive loss of renal function. However, therapy differs depending on the pathologic lesion. The lupus nephritis treatment strategies briefly emphasize the maximal preservation of renal function and patient protection from long-term consequences, mainly end-stage renal disease (ESRD) requiring dialysis or renal transplantation. In general, the mainstays for addressing lupus nephritis are mainly dominated by glucocorticosteroids (prednisone or methylprednisolone), immunosuppressants (cyclophosphamide, azathioprine, mycophenolate mofetil (MMF), others (monoclonal antibodies, such as rituximab), and adjunctive therapies (such as hydroxychloroquine, angiotensin-converting enzyme (ACE) inhibitor, angiotensin receptor blockers, etc.). In January 2021, Aurinia Pharmaceuticals, a spin-out from Vifor Pharma, announced that FDA approved Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis. The approval of voclosporin is based on data taken from two positive pivotal trials – the AURORA Phase III study and the AURA-LV Phase II study. In December 2020, GlaxoSmithKline announced that FDA approved Benlysta (belimumab) in intravenous and subcutaneous formulations for the treatment of adult patients with active lupus nephritis, receiving standard therapy. Talking about the emerging lupus nephritis treatment landscape, several companies, including Roche, Novartis, AstraZeneca, and Boehringer Ingelheim, are eyeing the existing untapped market of lupus nephritis and trying their best to grab a significant market share in the 7MM. Some of the emerging therapies had already demonstrated positive late-stage results among the lupus nephritis-affected individuals and include therapies such as- · GAZYVA – being developed by Roche, a third-generation, first humanized and glycoengineered CD20-directed cytolytic antibody, which is in the Phase III stage of clinical development. · Saphnelo (Anifrolumab) – being produced by AstraZeneca, an investigational, fully human monoclonal antibody · Novartis's Iscalimab – a new, fully human, monoclonal antibody, etc. Discover which therapy is expected to grab a substantial lupus nephritis market share by downloading the report snapshot @ lupus nephritis market landscape Key Lupus Nephritis Pipeline Therapies and Companies GAZYVA: Roche Saphnelo (Anifrolumab): AstraZeneca Iscalimab: Novartis Cosentyx: Novartis Zanubrutinib: BeiGene Ravulizumab: Alexion Pharmaceuticals Anifrolumab: AstraZeneca Itolizumab: Equillium To know about more pipeline therapies, check @ lupus nephritis pipeline analysis, clinical trials, and emerging therapies Lupus Nephritis Market Drivers and Barriers Factors responsible for the anticipated growth in the lupus nephritis market include the increasing prevalence of this disease assisted by organizational support and a promising pipeline constituting late-stage products that are expecting their approval. Other additional factors are extensive research and development, awareness, and a surge in the number of clinical studies contributing to the lupus nephritis market growth. On the contrary, several aspects such as a high cost of treatment, the need for novel therapeutics as well as a need for a targeted treatment regimen can all serve as potential lupus nephritis market drawbacks. Know which lupus nephritis therapy is expected to score the touchdown first @ lupus nephritis market landscape and forecast Scope of the lupus nephritis market report Study period: 2019–2032 Coverage: 7MM (The United States, EU5 [Germany, France, Italy, Spain, and the United Kingdom], and Japan) Key lupus nephritis companies: Aurinia Pharmaceuticals, Roche, AstraZeneca, Boehringer Ingelheim, Novartis, Novartis Pharmaceuticals, Hoffmann-La Roche, Janssen Research and Development, BeiGene, Suzhou Suncadia Biopharmaceuticals Co., Ltd., Alexion Pharmaceuticals, Omeros Corporation, Corestem, Inc., Bristol-Myers Squibb, Boehringer Ingelheim, Apellis Pharmaceuticals, AstraZeneca, Kezar Life Sciences, Equillium, Eledon Pharmaceuticals, Resolve Therapeutics, and others Key lupus nephritis pipeline therapies: GAZYVA, Saphnelo (Anifrolumab), Iscalimab, Cosentyx, Zanubrutinib, Ravulizumab, Anifrolumab, Itolizumab, and others Therapeutic assessment: lupus nephritis current marketed and emerging therapies Market dynamics: lupus nephritis market drivers and barriers Competitive intelligence analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Market Access and Reimbursement Discover more about the future market share of lupus nephritis treatment therapies @ lupus nephritis market forecast Table of Contents For further information on Market Impact by Therapies @ lupus nephritis market analysis Get in touch with our Business executive @ lupus nephritis market landscape analysis Related Reports Graft-versus-host disease (GvHD) Market DelveInsight's "Graft-versus-host disease (GvHD) Market Insights Report" offers comprehensive details of pathophysiology and various diagnostic approaches, treatment algorithms. 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About DelveInsight DelveInsight is a leading business consultant and market research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us - LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 SOURCE DelveInsight Business Research, LLP