Clemizole hydrochloride

WAKIX® (pitolisant) Net Revenue of $172.8 Million for Second Quarter 2024; ~29% Growth Year-over-Year Next Generation Pitolisant High-Dose (HD) Program Advances Based on Pilot Pharmacokinetic (PK) Data with PDUFA Date Expected in 2028 to Extend Pitolisant Franchise Beyond 2040 WAKIX Patent Upheld Again - U.S. Patent and Trademark Office (USPTO) Issues Final Denial After Two Attempts to Challenge the WAKIX Patent Received U.S. Food and Drug Administration (FDA) Approval and Launched WAKIX for the Treatment of EDS in Pediatric Patients with Narcolepsy Providing the First and Only Non-Scheduled Treatment Option On Track to Submit Supplemental New Drug Application for Pitolisant in Idiopathic Hypersomnia (IH) in Fourth Quarter 2024 Reiterates 2024 Net Product Revenue Guidance of $700 - $720 Million Company to Host Investor Day in New York City on October 1st Conference Call and Webcast to be Held Today at 8:30 a.m. ET PLYMOUTH MEETING, Pa., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today reported year-over-year net revenue growth of 29 percent for the quarter ended June 30, 2024. In addition, with the goal of addressing ongoing unmet medical needs in the narcolepsy market, the next generation pitolisant-HD development program is advancing and on track towards an expected PDUFA date in 2028. “We made substantial progress and continue to advance our pitolisant high-dose development program, targeting a PDUFA date in 2028, giving us the opportunity to extend the pitolisant franchise beyond 2040,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony. “In addition, we are executing on our late-stage pipeline across three orphan/rare CNS franchises, which we expect to deliver at least one new product or indication launch every year over the next five years, with multi-billion-dollar revenue potential extending beyond 2040. We also delivered another strong quarter of revenue growth for WAKIX, confirming our confidence in WAKIX being a billion dollar plus market opportunity in narcolepsy alone, while gaining the approval and launching WAKIX in pediatric narcolepsy.” Key Franchise Highlights: Sleep/Wake WAKIX Net Revenue of $172.8 million in the second quarter of 2024, representing 29% growth over the same period in 2023.The average number of patients on WAKIX increased by approximately 250 patients sequentially to approximately 6,550 for the quarter ended June 30, 2024.WAKIX patent upheld again. We announced that the USPTO has issued a final denial of the petition for reexamination, which was filed by a short seller. This denial is non-appealable and reinforces our confidence in the strength of our patents, the validity of the patent portfolio, and our ability to rigorously enforce the intellectual property rights protecting WAKIX.Received FDA approval for WAKIX for the treatment of EDS in pediatric patients 6 years and older with narcolepsy on June 21, 2024, and executed commercial launch July 1, 2024.On track to submit supplemental new drug application (sNDA) for pitolisant in IH in the fourth quarter of 2024.Pitolisant Gastro-Resistant (GR): On track to initiate Dosing Optimization study in the fourth quarter of 2024 and Pivotal Bioequivalence study in the first quarter of 2025. PDUFA date expected in 2026. Provisional patent filed with the potential for patent protection out to 2044.Pitolisant HD: Pilot PK data showed meaningful differentiation with at least a ~ 20% increase in relative bioavailability and a decrease in the variability of the PK profile compared to an equivalent WAKIX dose of 35.6 mg, the highest labeled dose. Formulation optimization work continues, and we plan to study up to two times the current highest labeled dose of WAKIX, where we expect to demonstrate a further increase in relative bioavailability and decrease in variability in the PK profile. An optimized PK profile, along with a higher dose, GR coating and targeting unique symptoms (e.g., fatigue in narcolepsy, in addition to EDS and cataplexy) is expected to provide a differentiated product profile and label compared to WAKIX. PDUFA date expected in 2028. Provisional patent filed with the potential for patent protection out to 2044.Patient enrollment is ongoing in Phase 3 TEMPO study in patients with Prader-Willi syndrome (PWS).TPM-1116, a highly potent and selective oral orexin-2 receptor agonist that will be evaluated for the treatment of narcolepsy and other sleep-wake disorders. IND enabling studies are ongoing and we expect to file an IND in mid-2025 and initiate first-in-human studies in the second half of 2025.Completed pre-clinical POC study for HBS-102 in PWS with encouraging initial results; final study report and results to be shared later this year. Neurobehavioral On track for topline data from the Phase 3 RECONNECT registrational trial of ZYN002 in Fragile X syndrome (FXS) in mid-2025.Phase 3 preparation ongoing for ZYN002 in 22q11.2 deletion syndrome (22q). Rare Epilepsy EPX-100 is a potent, oral, centrally acting serotonin (5HT2) agonist, currently in a pivotal registrational trial (ARGUS) for Dravet syndrome (DS) with topline data expected in 2026.Phase 3 trial for Lennox-Gastaut syndrome (LGS), expected to initiate later this year.EPX-200 is a potent, oral, centrally acting and selective 5HT2C agonist, and is currently in IND-enabling stage. Second Quarter 2024 Financial Results Net product revenues for the quarter ended June 30, 2024, were $172.8 million, compared to $134.2 million for the same period in 2023. The 29% growth versus the same period in 2023 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients diagnosed with narcolepsy in the US) and the broad clinical utility of WAKIX across the approximately 9,000 HCPs that we call on (about 5,000 of whom do not participate in an oxybate REMS program). The average number of patients on WAKIX increased by approximately 250 sequentially to approximately 6,550 for the quarter ended June 30, 2024. GAAP net income for the quarter ended June 30, 2024, was $11.6 million, or $0.20 earnings per diluted share, compared to GAAP net income of $34.3 million, or $0.56 earnings per diluted share, for the same period in 2023. The decrease in GAAP net income was primarily driven by a $25.5 million upfront licensing fee paid as part of the 2024 Bioprojet Sublicensing Agreement for TPM-1116 and a $17.1 million IPR&D charge related to the acquisition of Epygenix. Non-GAAP adjusted net income was $60.6 million, or $1.05 earnings per diluted share, for the quarter ended June 30, 2024, compared to Non-GAAP adjusted net income of $45.9 million, or $0.76 per diluted share, for the same period in 2023. Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release. Harmony’s operating expenses include the following: Research and Development expenses were $63.6 million in the second quarter of 2024, as compared to $15.0 million for the same quarter in 2023, representing a 325% increase, primarily driven by a $25.5 million upfront licensing fee as part of the 2024 Bioprojet Sublicense Agreement and a $17.1 million IPR&D charge related to the acquisition of Epygenix;Sales and Marketing expenses were $28.5 million in the second quarter of 2024, as compared to $24.5 million for the same quarter in 2023, representing a 16% increase;General and Administrative expenses were $27.2 million in the second quarter of 2024, as compared to $22.8 million for the same quarter in 2023, representing a 19% increase; andTotal Operating Expenses were $119.3 million in the second quarter of 2024, as compared to $62.3 million for the same quarter in 2023, representing a 92% increase. As of June 30, 2024, Harmony had cash, cash equivalents and investments of $434.1 million, compared to $425.6 million as of December 31, 2023. Reiterates 2024 Net Product Revenue Guidance Expect full year 2024 net product revenue of $700 million to $720 million. Share Repurchase Program The remaining amount of common stock authorized for repurchases as of June 30, 2024, was $150 million. Investor Day on October 1st The company will host an investor day in New York City on October 1st. Additional event details to follow. Conference Call Today at 8:30 a.m. ET We are hosting our second quarter 2024 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern Time. The live and replay webcast of the call will be available on the investor relations page of our website at https://ir.harmonybiosciences.com/. To participate in the live call by phone, dial (800) 225-9448 (domestic) or +1 (203) 518-9708 (international), and reference passcode HRMYQ224. Non-GAAP Financial Measures In addition to our GAAP results, we present certain Non-GAAP metrics including Non-GAAP adjusted net income and Non-GAAP adjusted net income per share, which we believe provides important supplemental information to management and investors regarding our performance. These measurements are not a substitute for GAAP measurements, and the manner in which we calculate Non-GAAP adjusted net income and Non-GAAP adjusted net income per share may not be identical to the manner in which other companies calculate adjusted net income and adjusted net income per share. We use these Non-GAAP measurements as an aid in monitoring our financial performance from quarter-to-quarter and year-to-year and for benchmarking against comparable companies. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our Non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our Non-GAAP financial measures. About WAKIX® (pitolisant) TabletsWAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy and has been commercially available in the U.S. since Q4 2019. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States. Indications and UsageWAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy. Important Safety Information ContraindicationsWAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment. Warnings and PrecautionsWAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment (see full prescribing information). WAKIX is not recommended in patients with end-stage renal disease (ESRD). Adverse ReactionsIn the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and at least twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash. Drug InteractionsConcomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half. Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required (see full prescribing information). H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists. WAKIX is a borderline/weak inducer of CYP3A4. Therefore, reduced effectiveness of sensitive CYP3A4 substrates may occur when used concomitantly with WAKIX. The effectiveness of hormonal contraceptives may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of therapy. Use in Specific PopulationsWAKIX may reduce the effectiveness of hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460. The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age. WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment. WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with moderate or severe renal impairment. Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers; these patients have higher concentrations of WAKIX than normal CYP2D6 metabolizers. Please see the Full Prescribing Information for WAKIX for more information. To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About NarcolepsyNarcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 170,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation (hallucinations and sleep paralysis), which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin/orexin, a neuropeptide in the brain that supports sleep-wake state stability. This disease affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed. About Idiopathic HypersomniaIdiopathic Hypersomnia (IH) is a rare and chronic neurological disease that is characterized by excessive daytime sleepiness (EDS) despite sufficient or even long sleep time. EDS in IH cannot be alleviated by naps, longer sleep or more efficient sleep. People living with IH experience significant EDS along with the symptoms of sleep inertia (prolonged difficulty waking up from sleep) and 'brain fog' (impaired cognition, attention, and alertness). The cause of IH is unknown, but it is likely due to alterations in areas of the brain that stabilize states of sleep and wakefulness. IH is one of the central disorders of hypersomnolence and, like narcolepsy, is a debilitating sleep disorder that can result in significant disruption in daily functioning. About Prader-Willi syndromePWS is an orphan/rare, genetic neurological disorder with many of the symptoms resulting from hypothalamic dysfunction. The hypothalamus is the part of the brain that controls both sleep-wake state stability and signals that mediate the balance between hunger and satiety, resulting in two of the main symptoms in patients with PWS; EDS and hyperphagia (an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety). Other features include low muscle tone, short stature, behavioral problems, and cognitive impairment. Approximately 15,000 to 20,000 people in the U.S. live with PWS, and over half of them experience EDS and the majority of them have behavioral disturbances. About ZYN002ZYN002 is the first-and-only pharmaceutically manufactured synthetic cannabidiol devoid of THC and formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The product is manufactured through a synthetic process in a cGMP facility and is not extracted from the cannabis plant. ZYN002 does not contain THC, the compound that causes the euphoric effect of cannabis, and has the potential to be a nonscheduled product if approved. Cannabidiol, the active ingredient in ZYN002, has been granted orphan drug designation by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of FXS and for the treatment of 22q. Additionally, ZYN002 has received FDA Fast Track designation for the treatment of behavioral symptoms in patients with FXS. About Fragile X SyndromeFragile X syndrome (FXS) is a rare genetic disorder that is the leading known cause of both inherited intellectual disability and autism spectrum disorder. The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities and behavioral symptoms, such as social avoidance and irritability. While the exact prevalence is unknown, upwards of 80,000 patients in the U.S. and 121,000 patients in the European Union and the UK are believed to have FXS, based on FXS prevalence estimates of approximately 1 in 4,000 to 7,000 in males and approximately 1 in 8,000 to 11,000 in females. There is a significant unmet medical need in patients living with FXS as there are currently no FDA approved treatments for this disorder. FXS is caused by a mutation in FMR1, a gene which modulates a number of systems, including the endocannabinoid system, and most critically, codes for a protein called FMRP. The FMR1 mutation manifests as multiple repeats of a DNA segment, known as the CGG triplet repeat, resulting in deficiency or lack of FMRP. FMRP helps regulate the production of other proteins and plays a role in the development of synapses, which are critical for relaying nerve impulses, and in regulating synaptic plasticity. In people with full mutation of the FMR1 gene, the CGG segment is repeated more than 200 times, and in most cases causes the gene to not function. Methylation of the FMR1 gene also plays a role in determining functionality of the gene. In approximately 60% of patients with FXS, who have complete methylation of the FMR1 gene, no FMRP is produced, resulting in dysregulation of the systems modulated by FMRP. About 22q11.2 Deletion Syndrome22q11.2 deletion syndrome (22q) is a disorder caused by a small missing piece of the 22nd chromosome. The deletion occurs near the middle of the chromosome at a location designated q11.2. It is considered a mid-line condition, with physical symptoms including characteristic palate abnormalities, heart defects, immune dysfunction, and esophageal/ GI issues, as well as debilitating neuropsychiatric and behavioral symptoms, including anxiety, social withdrawal, ADHD, cognitive impairment and autism spectrum disorder. It is estimated that 22q occurs in one in 4,000 live births, suggesting that there are approximately 80,000 people living with 22q in the U.S. and 129,000 in the European Union and the UK. Patients with 22q deletion syndrome are managed by multidisciplinary care providers, and there are currently no FDA approved treatments for this disorder. About Clemizole hydrochloride (EPX-100)EPX-100, clemizole hydrochloride, is under development for the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). EPX-100 acts by targeting central 5-hydroxytryptamine receptors to modulate serotonin signaling. The drug candidate is administered orally twice a day in a liquid formulation and has been developed based on a proprietary phenotype-based zebrafish drug screening platform.1 DS is caused by a loss of function mutation in the SCN1A gene, and scn1 mutant zebrafish replicate the genetic etiology and phenotype observed in the majority of DS patients. The scn1Lab mutant zebrafish model that expresses voltage gated sodium channels has been used for high-throughput screening of compounds that modulate Nav1.1 in the central nervous system. About Dravet SyndromeDravet syndrome (DS) is a severe and progressive epileptic encephalopathy that begins in infancy and causes significant impact on patient functioning. DS begins in the first year of life and is characterized by high seizure frequency and severity, intellectual disability, and a risk of sudden unexpected death in epilepsy. Approximately 85% of Dravet Syndrome cases are caused by de novo loss-of-function (LOF) mutations in a voltage-gated sodium channel gene, SCN1A1. DS has an estimated incidence rate of 1:15,700. About Lennox-Gastaut SyndromeLennox-Gastaut Syndrome (LGS) is a rare and drug-resistant epileptic encephalopathy characterized by onset in children between 3-5 years of age. The underlying cause of LGS is unknown and can be related to a wide range of factors including genetic differences and structural differences in the brain. As a result, patients experience multiple seizure types, including atonic seizures, and developmental, cognitive, and behavioral issues. LGS affects approximately 48,000 patients in the U.S. About Harmony BiosciencesAt Harmony Biosciences, we specialize in developing and delivering treatments for rare neurological diseases that others often overlook. We believe that where empathy and innovation meet, a better life can begin for people living with neurological diseases. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, PA, our team of experts from a wide variety of disciplines and experiences is driven by our shared conviction that innovative science translates into therapeutic possibilities for our patients, who are at the heart of everything we do. For more information, please visit www.harmonybiosciences.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2024 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe and the significant costs and required management time as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 22, 2024, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME(In thousands, except share and per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023Net product revenue $172,814 $134,216 $327,429 $253,342 Cost of product sold 32,144 25,008 59,628 45,788 Gross profit 140,670 109,208 267,801 207,554 Operating expenses: Research and development 63,583 14,969 85,772 28,258 Sales and marketing 28,507 24,528 55,740 47,100 General and administrative 27,224 22,809 52,900 44,871 Total operating expenses 119,314 62,306 194,412 120,229 Operating income 21,356 46,902 73,389 87,325 Other (expense) income, net 37 (31) (104) (29)Interest expense (4,404) (6,218) (8,939) (11,949)Interest income 4,705 3,442 9,133 6,528 Income before income taxes 21,694 44,095 73,479 81,875 Income tax expense (10,103) (9,795) (23,554) (18,090)Net income $11,591 $34,300 $49,925 $63,785 Unrealized (loss) income on investments (63) (491) (236) (371)Comprehensive income $11,528 $33,809 $49,689 $63,414 EARNINGS PER SHARE: Basic $0.20 $0.57 $0.88 $1.07 Diluted $0.20 $0.56 $0.87 $1.05 Weighted average number of shares of common stock - basic 56,802,357 59,974,123 56,786,873 59,853,808 Weighted average number of shares of common stock - diluted 57,541,696 60,743,953 57,571,570 60,997,410 HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIESCONSOLIDATED BALANCE SHEETS (In thousands except share and per share data) June 30, December 31, 2024 2023ASSETS CURRENT ASSETS: Cash and cash equivalents $317,296 $311,660 Investments, short-term 29,614 41,800 Trade receivables, net 83,157 74,140 Inventory, net 5,643 5,363 Prepaid expenses 16,127 12,570 Other current assets 6,507 5,537 Total current assets 458,344 451,070 NONCURRENT ASSETS: Property and equipment, net 754 371 Restricted cash 270 270 Investments, long-term 87,178 72,169 Intangible assets, net 125,186 137,108 Deferred tax asset 180,186 144,162 Other noncurrent assets 6,465 6,298 Total noncurrent assets 400,039 360,378 TOTAL ASSETS $858,383 $811,448 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Trade payables $22,683 $17,730 Accrued compensation 9,641 23,747 Accrued expenses 91,644 99,494 Current portion of long-term debt 15,000 15,000 Other current liabilities 7,614 7,810 Total current liabilities 146,582 163,781 NONCURRENT LIABILITIES: Long-term debt, net 171,422 178,566 Other noncurrent liabilities 1,796 2,109 Total noncurrent liabilities 173,218 180,675 TOTAL LIABILITIES 319,800 344,456 COMMITMENTS AND CONTINGENCIES (Note 13) STOCKHOLDERS’ EQUITY: Common stock—$0.00001 par value; 500,000,000 shares authorized at June 30, 2024 and December 31, 2023, respectively; 56,833,771 and 56,769,081 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively 1 1 Additional paid in capital 632,168 610,266 Accumulated other comprehensive (loss) income (234) 2 Accumulated deficit (93,352) (143,277)TOTAL STOCKHOLDERS’ EQUITY 538,583 466,992 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $858,383 $811,448 HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIESRECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS(In thousands except share and per share data) Three Months Ended Six Months Ended June 30, June 30, June 30, June 30, 2024 2023 2024 2023GAAP net income $11,591 $34,300 $49,925 $63,785 Non-GAAP Adjustments: Non-cash interest expense (1) 176 424 356 840 Depreciation 91 103 254 206 Amortization (2) 5,961 5,961 11,922 11,922 Stock-based compensation expense 10,963 7,793 21,397 14,354 Licensing fee and milestone payments (3) 25,500 - 25,500 750 Transaction related costs (4) 17,095 - 17,095 - Income tax effect related to non-GAAP adjustments (5) (10,769) (2,712) (15,119) (5,252)Non-GAAP adjusted net income $60,608 $45,869 $111,330 $86,605 GAAP reported net income per diluted share $ 0.20 $ 0.56 $0.87 $1.05 Non-GAAP adjusted net income per diluted share $1.05 $0.76 $1.93 $1.42 Weighted average number of shares of common stock used in non-GAAP diluted per share 57,541,696 60,743,953 57,571,570 60,997,410 (1) Includes amortization of deferred finance charges.(2) Includes amortization of intangible asset related to WAKIX.(3) Amount represents upfront licensing fee incurred upon closing the 2024 Bioprojet Sublicense Agreement and milestone payment related to HBS102 in March 2023.(4) Includes IPR&D charge related to the acquisition of Epygenix. (5) Calculated using the reported effective tax rate for the periods presented less impact of discrete items. Harmony Biosciences Investor Contact:Brennan Doyle484-539-9700bdoyle@harmonybiosciences.com Harmony Biosciences Media Contact:Cate McCanless202-641-6086cmccanless@harmonybiosciences.com

正文共： 20060字 0 图预计阅读时间： 51分钟2024年5月5日，药时代发布文章《2024年至今：24笔并购（M&A）交易，总金额520.2亿美元，单笔金额都远低于2023年》，对2024年前4个月全球制药界发生的M&A交易进行了汇总和简单的分析。现在，我们分享这24笔交易的较为详细的信息以及汇总表单，供广大朋友们参考。欢迎大家批评指正！衷心感谢！1      宣布时间：5/2/24       收购方：Novartis      被收购方：Mariana Oncology      交易总金额：17.5亿美元瑞士制药公司诺华（Novartis）已同意收购生物技术公司Mariana Oncology，这是一家位于马萨诸塞州沃特敦的临床前阶段生物技术公司，专注于开发用于治疗具有高未满足需求的癌症患者的新型放射性配体治疗药物（RLTs）。此次收购将加强诺华在放射性配体治疗（RLT）领域的产品线，并扩展公司的研究基础设施和临床供应能力。根据协议，诺华将支付10亿美元的前期款项，并在完成特定里程碑后支付高达7.5亿美元的额外款项。Mariana Oncology已经开发了针对多种实体肿瘤适应症的RLT项目组合，包括针对乳腺癌、前列腺癌和肺癌的候选药物MC-339，这是一种正在研究中的锕基RLT，用于治疗小细胞肺癌。Mariana Oncology的创始团队由世界上领先的放射性药物科学和制造专家组成，他们共同开创了放射性配体治疗的创新。此次收购不仅为诺华带来了Mariana Oncology的人才和新能力，还增强了诺华在放射性配体治疗领域的领导地位，并有望推动下一代RLT的开发，为癌症患者带来潜在的变革性治疗。诺华对Mariana Oncology的收购将使其能够进入其他放射性同位素领域，特别是Mariana Oncology专注于放射性金属元素锕，而诺华其他批准的放射性配体治疗药物使用的是镥。此次交易还突显了诺华在放射性药物领域的战略重点，诺华此前在放射性药物领域已有布局，包括2018年收购Advanced Accelerator Applications和Endocyte，以及近期与3B Pharmaceuticals、Bicycle Therapeutics和PeptiDream的合作。总的来说，这次收购将有助于诺华在癌症治疗领域进一步巩固其作为放射性配体治疗领导者的地位，并为其带来新的增长机会。【推荐阅读】火热核药赛道又出并购交易！诺华以17.5亿美元收购Mariana Oncology2      宣布时间：4/30/24       收购方：Harmony Biosciences       被收购方：Epygenix Therapeutics       交易总金额：6.8亿美元Harmony Biosciences, Inc.（纳斯达克股票代码：HRMY）宣布收购了Epygenix Therapeutics, Inc.，这是一家精准医药为基础的生物制药公司，专注于开发治疗罕见且难治的儿童遗传性癫痫疾病，如Dravet综合征（DS）。此次收购加速了Harmony Biosciences的增长战略，为其不断扩展的创新中枢神经系统（CNS）资产后期管线增加了罕见癫痫特许经营权。根据公告，Epygenix Therapeutics正在开发的两种药物候选物EPX-100和EPX-200，是在DS的斑马鱼模型中发现的，该模型复制了导致DS的遗传突变并模仿人类病理。这种作用机制已被证明可以消除临床和电图发作活动，这可能转化为改善患者功能。Harmony Biosciences的首席执行官Jeffrey M. Dayno医学博士表示，"Epygenix的收购为我们提供了三个不同的CNS特许经营权，每个在美国的峰值销售机会为10亿至20亿美元。" 他还指出，公司一直在战略性地构建一个稳健多样的罕见病创新CNS资产管线，这已经转变了他们的业务。此次收购建立在他们在睡眠/觉醒和神经行为障碍领域的领导地位之上，使他们能够利用在CNS方面的专业知识和内部协同作用，为有未满足医疗需求的患者提供新疗法。此外，Harmony Biosciences在2024年2月22日向美国证券交易委员会（SEC）提交的经修订的年度报告10-K表中，讨论了可能影响公司未来实际结果、表现或成就与前瞻性声明所表达或暗示的未来结果、表现或成就有实质性不同的风险因素。此次收购的初始现金支付为3500万美元，并且交易中还包含了超过6亿美元的额外潜在支付。3      宣布时间：4/29/24       收购方：Ono Pharmaceutical       被收购方：Deciphera Pharmaceuticals       交易总金额：24亿美元Ono Pharmaceutical Co., Ltd.（小野制药）已宣布与Deciphera Pharmaceuticals, Inc.达成最终合并协议。根据协议，Ono Pharmaceutical将以每股25.60美元的现金价格收购Deciphera的所有流通股份，整个交易的股权价值约为24亿美元。这一收购将通过一个后续的合并要约进行，预计将在2024年日历年的第三季度完成，但须符合常规的交易完成条件，包括美国反垄断许可和Deciphera大部分流通股份的接受要约。Deciphera Pharmaceuticals是一家生物制药公司，专注于发现、开发和商业化用于改善癌症患者生活的新药物。Deciphera的产品线中，QINLOCK®（ripretinib）是一种KIT抑制剂，在40多个国家获得批准，用于治疗接受过三种或以上激酶抑制剂治疗的成人晚期胃肠道间质瘤（GIST）患者。此外，Deciphera还开发了Vimseltinib，这是一种CSF-1R抑制剂，在临床试验中显示出治疗腱鞘巨细胞瘤（TGCT）的有希望的结果，并获得了FDA的快速通道认定。通过此次收购，Ono Pharmaceutical旨在加强其在肿瘤学领域的产品线，扩大其在全球范围内的影响力，并加速在癌症治疗领域的研究和开发工作。Deciphera的商业运营和研发专长将为Ono Pharmaceutical带来在美国和欧洲市场的即时收入增长机会，以及推动其成为全球专业制药公司的努力。Ono Pharmaceutical是一家全球专业制药公司，专注于肿瘤学、免疫学、神经学和专业领域，致力于开发具有高医疗需求的创新药物。此次收购将有助于Ono Pharmaceutical实现其全球化目标，并加强其在关键研究领域的药物发现能力。收购完成后，Ono Pharmaceutical将获得Deciphera在激酶药物发现方面的专业研发能力，以及在美国和欧洲建立的销售和商业平台，这将有助于Ono Pharmaceutical加速其肿瘤学研究和开发工作，并扩大其全球影响力。此次收购是Ono Pharmaceutical为了加强其在肿瘤学领域的产品线，扩大其全球影响力，并加速在癌症治疗领域的研究和开发工作而采取的战略举措。4      宣布时间：4/23/24       收购方：Incyte       被收购方：Escient Pharmaceuticals       交易总金额：7.5亿美元Incyte（纳斯达克股票代码：INCY）宣布与Escient Pharmaceuticals达成最终协议，将收购这家临床阶段的药物发现和开发公司。Escient Pharmaceuticals专注于开发针对系统性免疫和神经免疫疾病的新型小分子治疗药物。根据协议，Incyte将以7.5亿美元现金收购Escient及其资产，包括两款潜在的“first-in-class”小分子疗法EP262和EP547。EP262是一种针对Mas相关G蛋白偶联受体X2（MRGPRX2）的一流、强效、高选择性的小分子拮抗剂，每日一次给药。EP547则是一种针对MRGPRX4的一流口服拮抗剂，具有治疗胆汁淤积性瘙痒和其他具有严重瘙痒症状的疾病的潜力。此次收购将支持Incyte扩大其在炎症与自身免疫疾病领域的研发管线。Incyte首席执行官Hervé Hoppenot表示，公司致力于创新和发现变革性药物，很高兴将EP262和EP547加入其产品组合，这符合公司开发具有高潜力的差异化一流药物的战略。Escient的总裁兼首席执行官Joshua A. Grass表示，这些候选药物是Escient员工和科学合作者进行的高度创新研究的结果。Incyte拥有经验丰富的开发和商业团队，以及商业和开发阶段产品组合，处于有利地位，可以将这项新科学转化为对患者有价值的药物。交易条款规定，Incyte将以7.5亿美元的价格收购Escient及其资产，再加上交易结束时Escient的剩余现金净额，并按惯例进行调整。此次收购须经《哈特-斯科特-罗迪诺法案》批准，并将在满足或放弃这些条件后立即生效，预计于2024年第三季度完成。Incyte是一家全球生物制药公司，致力于原创药物的发现、开发和商业化。通过此次收购，Incyte将获得Escient在MRGPR拮抗剂领域的专业知识和产品线，有望为患者提供更多治疗选择。5      宣布时间：4/10/24       收购方：Vertex       被收购方：Alpine lmmune Sciences       交易总金额：49亿美元Vertex Pharmaceuticals Incorporated（纳斯达克股票代码：VRTX），一家位于波士顿的生物技术公司，专注于发现和开发创新的蛋白基免疫疗法，宣布与Alpine Immune Sciences, Inc.（纳斯达克股票代码：ALPN）签订了最终收购协议。根据协议，Vertex将以每股65美元的现金价格收购Alpine，整个交易的股权价值约为49亿美元。Alpine Immune Sciences是一家专注于开发用于自身免疫和炎症性疾病的蛋白类免疫疗法的临床阶段生物技术公司。该公司的主要产品povetacicept（ALPN-303）是一种BAFF（B细胞活化因子）和APRIL（增殖诱导配体）细胞因子的双重拮抗剂，在II期针对IgA肾病（IgAN）的临床试验中显示出了同类最佳的潜在疗效。此次收购将加强Vertex在免疫疗法领域的地位，特别是在肾病治疗方面的布局。Povetacicept预计将在2024年下半年进入III期临床开发阶段，面对的是一个巨大的肾病市场机会。Vertex的首席执行官Reshma Kewalramani表示，Alpine是Vertex的“引人注目的战略契合点”，此次收购将帮助公司实现其“利用科学创新创造针对严重疾病的变革性药物的雄心壮志，这些疾病在专业市场上的需求尚未得到满足”。该交易已获得两家公司董事会的一致批准，预计将于2024年第二季度完成，等待反垄断批准、股东批准和其他习惯条件。6      宣布时间：4/5/24       收购方：Merck & Co.       被收购方：Abceutics       交易总金额：2.08亿美元默克公司（Merck & Co., 简称Merck，在美国和加拿大以外地区称为MSD）已经完成了对Abceutics的收购。Abceutics是一家临床前生物制药公司，由纽约州立大学布法罗分校（University at Buffalo）研究员Joseph P. Balthasar博士的实验室分拆而来。这笔交易的潜在对价高达2.08亿美元，其中包括根据候选药物进展的里程碑付款。Abceutics成立于2020年，专注于开发旨在改善抗体-药物偶联物（ADCs）的递送和安全性的技术，这是一种靶向癌症治疗方法。ADCs由单克隆抗体与细胞毒性有效载荷通过连接器偶联而成，抗体组分将药物特异性靶向特定的癌症细胞，而细胞毒性有效载荷则利用高效的细胞杀伤特性杀死靶向的癌症细胞。Abceutics的技术通过开发有效载荷结合选择性增强剂（PBSEs），旨在通过选择性中和非靶细胞中的有害物质来最大程度地减少与ADC疗法相关的副作用。具体而言，PBSEs通过结合并中和血流中的游离有效载荷，可以安全地施用更高剂量的ADC，从而可能提高其治疗效果。默克公司对Abceutics的兴趣源于PBSE技术提高ADC治疗指数的潜力，这是癌症治疗有效性的关键因素。通过这项收购，默克公司将获得Abceutics的PBSE平台，该平台与ADCs协同工作，通过寻找并中和ADCs的游离有效载荷分子，减少这些分子对健康细胞的影响。此外，Abceutics已经从包括美国国立卫生研究院（National Institutes of Health）在内的多个机构获得了支持，并且从布法罗创新加速器基金获得了11万美元的早期资金。默克公司研发实验室肿瘤发现副总裁David Weinstock博士表示，Abceutics团队已经通过一系列候选管线和令人信服的早期证据，在将这一新颖想法转化为现实方面取得了显著进展，并期待进一步评估这种创新方法在临床上的潜力。这笔交易标志着默克公司在ADC领域的进一步扩张，去年10月，默克与第一三共达成220亿美元的合作，共同开发和共同商业化第一三共的三个ADC候选产品：patritumab deruxtecan、ifinatamab deruxtecan和raludotatug deruxtecan。收购Abceutics后，默克公司将能够利用其在癌症研究方面的专长和能力，继续探索和发展PBSE技术，以期提高ADC疗法的安全性和疗效。7      宣布时间：4/3/24       收购方：Genmab       被收购方：ProfoundBio       交易总金额：18亿美元Genmab A/S（纳斯达克股票代码：GMAB），一家位于丹麦的生物技术公司，已宣布与临床阶段的生物技术公司ProfoundBio（普方生物）达成最终协议，Genmab将以18亿美元的全现金交易收购ProfoundBio。普方生物是一家专注于开发下一代抗体-药物偶联物（ADC）治疗特定类型癌症的公司，包括卵巢癌和其他表达FRα的实体瘤。此次收购将扩大Genmab的临床渠道，补充其技术平台，并授予其在全球范围内拥有普方生物ADC产品组合的权利，包括目前处于临床试验第二阶段的Rina-s。普方生物的ADC产品组合中，rinatabart sesutecan (Rina-S; PRO1184) 是一种靶向FRα的ADC，已处于1/2期临床试验的第2期，用于治疗卵巢癌和其他FRα表达实体瘤。美国食品和药物管理局（U.S. FDA）于2024年1月授予Rina-S快速通道资格，用于治疗表达FRα的、高级别浆液性或子宫内膜样铂耐药的卵巢癌患者。此外，普方生物的新型ADC技术平台与Genmab的专有抗体平台相结合，将有可能创造新的机会并产生和开发出新的药物，有可能改变癌症的治疗方法，改善患者的生活。此次交易已获得两家公司董事会的一致批准，并预计将于2024年上半年完成。这笔交易也是迄今为止中国生物技术公司被海外药企收购的最大一笔交易。普方生物自成立以来，已获得包括险峰旗云、高榕创投、红杉中国等数十家知名机构的投资。8      宣布时：3/25/24       收购方：Nuvation Bio       被收购方：AnHeart Therapeutics（葆元医药）       交易总金额：All stock 全股票交易Nuvation Bio Inc.（纽约证券交易所代码：NUVB）宣布完成了对AnHeart Therapeutics Ltd.（AnHeart）的收购。AnHeart是一家为癌症患者开发新型精准疗法的临床阶段全球生物制药公司。收购完成后，AnHeart成为了Nuvation Bio的全资子公司。通过这次收购，Nuvation Bio获得了taletrectinib（一种下一代、潜在同类最佳的ROS1抑制剂，目前完成针对ROS1阳性非小细胞肺癌[NSCLC]患者的两项关键研究）以及safusidenib（一种潜在同类最佳的突变IDH1抑制剂，目前正在进行针对2级和3级IDH1突变胶质瘤患者的全球2期研究）。这次全股票交易保留了Nuvation Bio强劲的现金余额，并使其能够在近期内无需筹集资金的情况下，发展新资产和当前的产品线。Nuvation Bio的创始人、总裁兼首席执行官David Hung博士表示，这次收购将Nuvation Bio转变成了一家资本充足的晚期全球肿瘤公司，为迈向成为商业组织的过程中开发新扩建的产品线做好了准备。大约90%的AnHeart股份持有人已经进入投票协议，他们同意投票支持这次收购。此外，Hung博士也签订了一个投票协议，同意将其持有的Nuvation Bio股份（约占公司已发行股份的27%）用于Nuvation Bio股东批准。Nuvation Bio预计将通过这次收购，能够免税重组，并在收购后作为AnHeart的母公司，拥有包括AnHeart知识产权在内的所有资产。这次收购预计将在2024年第二季度完成，已经得到了双方董事会的批准，并满足AnHeart股东的批准和其他惯例成交条件。Nuvation Bio将继续开发safusidenib，这是一种由AnHeart评估的新型、选择性、强效的口服mIDH1抑制剂，目前正在进行全球2期研究（NCT05303519），针对2级和3级IDH1突变胶质瘤患者。AnHeart Therapeutics是一家专注于开发新型精准疗法的全球临床阶段生物制药公司，其主要研究性疗法taletrectinib是一种下一代ROS1抑制剂，目前正处于ROS1阳性非小细胞肺癌（NSCLC）的关键2期临床试验中。Taletrectinib已获得美国食品药品监督管理局（FDA）和中国国家药品监督管理局（NMPA）的突破性疗法认定。AnHeart拥有taletrectinib的全球权利，但大中华区、日本和韩国的商业权利已分别授权给Innovent Biologics、日本化药和NewG Lab。AnHeart拥有safusidenib的全球权利，但日本的权利由第一三共制药保留。Nuvation Bio是一家临床阶段的全球生物制药公司，致力于开发用于解决肿瘤学中一些最大未满足需求的差异化和新型治疗候选药物。Nuvation Bio的开发候选药物包括taletrectinib（ROS1）、safusidenib（mIDH1）、NUV-868（BET）和NUV-1511（DDC）。Nuvation Bio由生物制药行业资深人士David Hung博士于2018年创立，他此前创立了Medivation, Inc.，该公司为患者带来了世界领先的前列腺癌药物之一。Nuvation Bio在纽约、旧金山和上海设有办事处。9      宣布时间：3/25/24       收购方：AbbVie       被收购方：Landos Biopharma      交易总金额：2.125亿美元AbbVie Inc.（艾伯维）已宣布与Landos Biopharma, Inc.（兰多斯生物制药）达成最终协议，根据该协议，AbbVie将以每股20.42美元的现金价格收购Landos Biopharma，总价值约为1.375亿美元。此外，交易还包括一项或有价值权（Contingent Value Right, CVR），每股价值高达11.14美元，如果达到特定的临床开发里程碑，总价值可能额外增加7500万美元，使得整个交易的价值达到约2.125亿美元。Landos Biopharma是一家临床阶段的生物制药公司，专注于开发用于自身免疫疾病患者的新型口服治疗药物。该公司的主要研究资产是NX-13，这是一种首创的、口服的NLRX1激动剂，属于NOD样受体家族，具有双重作用机制（MOA），既具有抗炎作用，也促进上皮修复。NX-13目前正在进行针对溃疡性结肠炎（UC）的随机对照II期NEXUS临床试验，该试验正在美国和欧洲招募患者（NCT05785715）。NLRX1激动剂通过调节免疫代谢和炎症，影响多种炎症性肠病（IBD）发病机制。此次收购将加强AbbVie在炎症和自身免疫疾病领域的投资组合，AbbVie旨在推进NX-13的临床开发，这是一种有潜力为患有溃疡性结肠炎和克罗恩病（Crohn's disease）的人们带来改变的差异化、首创的口服药物。该交易预计将在2024年第二季度完成，但须符合常规的交易完成条件，包括Landos股东的批准。通过此次收购，AbbVie旨在加强其在炎症性疾病药物领域的产品线，特别是针对溃疡性结肠炎和克罗恩病的新疗法。10      宣布时间：3/25/24       收购方：Novo Nordisk       被收购方：Cardior Pharmaceuticals       交易总金额：11亿美元诺和诺德（Novo Nordisk）宣布已同意收购Cardior Pharmaceuticals，以加强其在心血管疾病领域的研发管线。根据收购协议，诺和诺德将以高达10.25亿欧元的价格收购Cardior，这包括预付款和在特定研发及商业里程碑达成之后的额外付款。Cardior Pharmaceuticals是一家专注于开发靶向RNA以预防、修复及逆转心脏疾病的生物制药公司。Cardior的先导化合物CDR132L是一种反义寡核苷酸（ASO）药物，它可以选择性阻断异常的miRNA分子miR-132水平，旨在阻止并部分逆转心脏疾病患者的疾病进程。CDR132L目前正处于治疗心力衰竭的II期临床试验阶段。诺和诺德计划在收购后启动后续试验，并表示此次收购不会影响其此前发布的2024年营业利润预期或正在进行的股票回购计划。此外，诺和诺德将使用其财务储备为此次收购提供资金。Cardior的首席执行官兼联合创始人Claudia Ulbrich博士表示，此次收购反映了CDR132L作为心衰疾病修饰治疗的转化潜力，诺和诺德凭借其深厚的临床和商业专业能力，能够加速CDR132L的后期开发计划。此项收购预计将于2024年第二季度完成，须获得相应监管机构的批准，并满足其他惯例条件。通过此次收购，诺和诺德希望在心血管疾病领域扩大业务范围和影响力，特别是在心力衰竭治疗方面。11      宣布时间：3/19/24       收购方：AstraZeneca       被收购方：Fusion Pharmaceuticals       交易总金额：24亿美元阿斯利康（AstraZeneca）在2024年3月19日宣布了与Fusion Pharmaceuticals达成的收购协议。根据协议，阿斯利康将以每股21美元的价格收购Fusion所有流通股，这个价格较Fusion在3月18日的收盘价10.64美元溢价了97%。此外，交易结束时，阿斯利康还将支付每股3美元的特定里程碑金额，预计总交易金额约为24亿美元。通过这次收购，阿斯利康将获得Fusion Pharmaceuticals的放射偶联药物管线，包括处于临床阶段的、基于同位素锕（actinium）的靶向前列腺特异性膜抗原（PSMA）的放射偶联药物，以及相关的研发与生产设施。Fusion Pharmaceuticals的主打项目FPI-2265，是一种基于锕225的PSMA靶向放射偶联药物，用于治疗转移性去势抵抗性前列腺癌（mCRPC），目前处于2期试验阶段。Fusion Pharmaceuticals专注于开发下一代放射性偶联药物（RCs），这类药物因其精准靶向、强力杀伤、有限损伤和诊疗一体的优势，被认为是一种颇具前景的肿瘤治疗方式。此次收购将为阿斯利康带来基于同位素锕225的放射偶联药物相关专业知识以及研发能力。此外，阿斯利康在官宣上述收购的新闻稿中提到，相比传统的放疗，放射性药物提供了更精准杀死癌细胞的机制，同时最大限度减少对健康细胞的毒性。这类药物可以全身给药，使得能够用于治疗无法接受外照放射治疗的肿瘤类型，并靶向从主要肿瘤扩散到体内其他部位的癌细胞。在收购之前，阿斯利康与Fusion早在2020年11月就达成了合作，共同开发和商业化下一代α粒子靶向放射性疗法和癌症联合疗法。这次收购是继诺华、礼来、百时美施贵宝（BMS）等其他跨国药企巨头通过收购和合作加码核药赛道之后的又一大动作。例如，诺华和拜耳是放射性药物领域的引领者，礼来此前以14亿美元收购POINT Biopharma，而BMS则以约41亿美元收购了RayzeBio。Fusion Pharmaceuticals成立于2014年12月，是一家临床阶段的肿瘤学公司，致力于开发下一代放射性药物作为精密药物。该公司已经开发了argeted Alpha疗法 (TAT) 平台，以及专有的Fast-Clear连接器技术，能够将发射a粒子的同位素与抗体和其他靶向分子连接起来，以选择性地将alpha粒子有效载荷传递到肿瘤上。阿斯利康是一家全球性的生物制药公司，自1993年以来，始终秉持“以患者为中心”的初心，以科学为本，不断开拓科学疆域，从药物研发、生产运营、商业模式等领域不断推动创新实践和可持续发展。这次收购预计将在今年第二季度完成，补充了阿斯利康在肿瘤学领域的布局，并加速了下一代放射性偶联药物的开发。12      宣布时间：3/14/24       收购方：AstraZeneca       被收购方：Amolyt Pharma       交易总金额：10.5亿美元阿斯利康（AstraZeneca）已宣布与Amolyt Pharma签订最终协议，将以高达10.5亿美元的总对价收购Amolyt Pharma。这笔交易包括8亿美元的前期支付，以及在实现特定监管里程碑时支付的额外2.5亿美元的或有支付。Amolyt Pharma是一家临床阶段的生物制药公司，专注于开发治疗罕见内分泌疾病和相关疾病的治疗肽。其主要候选药物Eneboparatide（AZP-3601）是一种每日注射的甲状旁腺激素受体1（PTH1）激动剂，用于治疗低副甲状腺激素血症，目前已进入III期临床试验。此外，Amolyt的临床管线还包括AZP-3813，这是一种肽生长激素受体拮抗剂，用于潜在治疗肢端肥大症，目前处于I期临床试验。阿斯利康通过此次收购，旨在加强其在罕见疾病领域的药物研发管线，尤其是针对低副甲状腺激素血症的治疗。Amolyt Pharma的加入将有助于阿斯利康在罕见内分泌疾病领域的扩展。交易预计将在2024年第三季度完成，但须满足收购协议中规定的常规完成条件，包括获得监管许可。此次收购将不会影响诺和诺德之前发布的2024年营业利润预期或正在进行的股票回购计划。通过此次收购，阿斯利康将利用其在罕见疾病领域的专业能力和全球网络，加速Amolyt Pharma产品管线的后期开发和全球商业化。13      宣布时间：3/13/24       收购方：Novartis       被收购方：IFM Due       交易总金额：8.35亿美元诺华（Novartis）已经完成了对IFM Therapeutics的子公司IFM Due的收购。根据2024年3月13日的公告，此次收购的总价值高达8.35亿美元，其中包括9000万美元的预付款以及可能高达7.45亿美元的里程碑支付。IFM Due是一家专注于开发先天免疫系统新靶点疗法的私营生物制药公司，其主要研发项目是抑制cGAS-STING途径的小分子药物，这些药物有潜力治疗多种严重的炎症驱动疾病，这些疾病的特征是干扰素和其他促炎细胞因子信号过度。诺华通过此次收购获得了IFM Due的STING拮抗剂组合的全部权利，这些STING拮抗剂是一类新型小分子药物，它们可能对一系列炎性疾病具有治疗潜力。诺华公司免疫学研究全球负责人Richard Siegel表示，此次收购代表了诺华与IFM之间为期四年的高效临床前合作的高潮，旨在开发具有治疗一系列炎性疾病潜力的新型小分子STING抑制剂。IFM首席执行官H. Martin Seidel表示，他们一直坚信选择性靶向STING阻断cGAS-STING途径有可能为严重慢性病患者提供强大的治疗选择，并且诺华一直是一个出色的合作者，这个项目再好不过了。此次收购标志着诺华在炎症科学领域的进一步扩展，旨在推进IFM Due的STING计划，并利用诺华在炎症科学方面的深厚专业知识，推出针对未满足患者主要需求的变革性药物。此外，这笔交易也是IFM Therapeutics在过去七年中第三次被全球制药公司收购的重大事件。14      宣布时间：2/26/24       收购方：The Column Group       被收购方：NGM Bio       交易总金额：1.35亿美元The Column Group, LP及其附属公司Atlas Neon Parent, Inc.和Atlas Neon Merger Sub, Inc.将通过现金收购要约收购NGM Biopharmaceuticals, Inc.（NGM Bio）。根据协议，NGM Bio的股东将获得每股1.55美元的现金价格，整个交易的估值为1.35亿美元。此次收购完成后，NGM Bio将成为一家私人控股公司，预计交易将在2024年第二季度完成。The Column Group是一家专注于生物技术领域的风险投资公司，是NGM Bio最长期和最大的股东，持有NGM Bio约26%的股份。NGM Bio是一家生物技术公司，专注于发现和开发变革性治疗药物。此次收购的价格相当于NGM Bio每股1.55美元，比2023年12月29日的收盘价溢价80%。NGM Bio的短期市场性证券、现金和现金等价物截至2023年9月30日总计为1.66亿美元，截至2023年12月31日约为1.44亿美元。美国律师事务所Paul, Weiss, Rifkind, Wharton & Garrison正在指导The Column Group的实体进行此次收购。交易完成后，NGM Bio将转型为一家私营公司，这将有助于公司在没有公开市场压力的情况下继续其药物开发工作。此次收购是The Column Group在生物技术领域的又一次重要投资，此前该集团已在NGM Bio的A轮融资中领投了2550万美元。通过此次收购，The Column Group将能够更直接地支持NGM Bio的研发活动，并推动其候选药物的开发和商业化。15      宣布时间：2/12/24       收购方：Gilead Sciences       被收购方：CymaBay Therapeutics       交易总金额：43亿美元吉利德科学公司（Gilead Sciences, Inc.）宣布与CymaBay Therapeutics达成最终收购协议，将以每股32.50美元的现金价格收购CymaBay，整个交易的总股本价值为43亿美元。CymaBay的主要在研产品是seladelpar，这是一种用于治疗原发性胆汁性胆管炎（PBC）的“first-in-class”口服PPARδ激动剂，包括其症状瘙痒。此次收购将加强吉利德在肝病领域的药物组合，与其现有的肝病产品相辅相成，并与其长期致力于带给患者变革性药物的承诺保持一致。吉利德预计，如果seladelpar获得批准，将有助于推动公司的收入增长，并在2025年后对每股收益产生积极影响。CymaBay在宣布收购的同一天还宣布，美国食品药品监督管理局（FDA）已经受理了seladelpar的新药上市申请（NDA），并且PDUFA（处方药用户费用法案）目标日期定为2024年8月14日。该药物曾于2019年获得FDA授予的突破性疗法认定。CymaBay的首席执行官Sujal Shah在一份声明中表示，与吉利德的协议是CymaBay多年来致力于推进seladelpar并为PBC患者及其家庭带来新希望的成果。现在seladelpar已经获得FDA的优先审评，他们很高兴吉利德能利用其在肝脏疾病患者治疗方面的长期承诺，将其监管和商业专长用于尽快将seladelpar带给PBC患者。此次收购的完成预计将在2024年第一季度进行，但须符合包括监管批准和其他惯常的交易完成条件。此外，吉利德和CymaBay还发布了有关此次收购的前瞻性声明，指出实际结果可能会因多种风险和不确定性而有所不同。收购完成后，吉利德将通过其在治疗和治愈肝脏疾病方面的长期专业知识，推进seladelpar的研发，并有望解决PBC患者的重要未满足需求。16      宣布时间：2/5/24       收购方：Novartis       被收购方：MorphoSys       交易总金额：29亿美元诺华公司（Novartis）宣布已与德国生物技术公司MorphoSys签订了一份自愿公开收购要约，收购价格约为29亿美元，以扩大其肿瘤学产品组合。根据协议，诺华将以每股超过73美元的价格收购MorphoSys的所有无面值不记名股票。两家公司预计将于2024年上半年完成交易，但还需满足惯例成交条件，如监管机构和反垄断机构的批准，以及MorphoSys至少65%的流通股股东的接受。此次收购的核心产品是正在研究中的小分子BET蛋白抑制剂pelabresib，它具有潜在的治疗骨髓纤维化（MF）的能力，并与芦可替尼（ruxolitinib）联用展现出良好的耐受性和安全性。此外，MorphoSys的管线还包括tulmimetostat，这是一种EZH1和EZH2的双重抑制剂，目前正在进行针对实体瘤或淋巴瘤的I/II期研究。诺华通过此次收购旨在加强其在肿瘤学领域的领先产品线和产品组合，提高其能力和专业技术。德国监管机构已经批准了这项交易，这将进一步扩展和补充诺华在肿瘤学这一优先治疗领域的产品线，同时加强诺华在血液学领域的全球布局。值得注意的是，诺华不会获得MorphoSys公司经FDA批准用于弥漫性大B细胞淋巴瘤治疗的Monjuvi（tafasitamab-cxix），因为该药的全球开发和商业化权在诺华与MorphoSys达成交易之前刚刚出售给Incyte公司。此次收购是诺华在肿瘤治疗领域战略布局的一部分，预计将在2024年下半年向美国FDA提交pelabresib的监管申请，尽管去年公布的III期MANIFEST-2研究结果喜忧参半。17      宣布时间：2/5/24       收购方：Novo Holdings       被收购方：Catalent       交易总金额：165亿美元Novo Holdings已宣布与Catalent达成合并协议，将以全现金交易的方式收购Catalent，该交易对Catalent的企业价值估值为165亿美元。根据协议，Novo Holdings将以每股63.50美元的现金收购Catalent的所有流通股，这个价格较Catalent截至2024年2月2日的60天成交量加权平均价格溢价47.5%。作为交易的一部分，Novo Holdings计划在交易完成后不久，将合并中收购的三个Catalent灌装工厂和相关资产出售给诺和诺德（Novo Nordisk），这三个站点位于意大利阿纳尼、美国印第安纳州布卢明顿和比利时布鲁塞尔。此次交易符合Novo Holdings投资具有强大长期潜力的成熟生命科学公司的战略，预计将在2024年年底完成。交易完成后，Catalent将成为一家私人公司，其股票将不再在纽约证券交易所交易。Catalent是全球领先的药物、生物制剂、基因疗法和消费者健康产品的先进给药技术和开发制造解决方案提供商，拥有85年的行业服务经验，在全球五大洲拥有超过40家工厂设施。此外，诺和诺德（Novo Nordisk）也宣布，作为Novo Holdings同意收购Catalent交易的一部分，诺和诺德将从Novo Holdings收购Catalent的三个灌装生产基地，预付款为110亿美元。这三个生产基地专门从事药品无菌灌装，收购将有助于诺和诺德当前和未来关于治疗糖尿病和肥胖症的制造网络，预计该生产基地收购于2024年底完成，将从2026年及以后逐步提高公司的灌装能力。18      宣布时间：1/23/24       收购方：Sanofi       被收购方：Inhibrx       交易总金额：17.5亿美元赛诺菲（Sanofi）已宣布收购临床阶段生物制药公司Inhibrx, Inc.，以增强其罕见病药物管线。根据最终协议，赛诺菲将在非INBRX-101资产分拆至新公司New Inhibrx之后收购Inhibrx。INBRX-101是一种用于治疗Alpha-1 Antitrypsin Deficiency (AATD)的人类重组蛋白，该疾病是一种遗传性罕见病，主要影响肺部，并导致肺组织逐渐恶化。INBRX-101有望通过每月而非每周的剂量就能使AATD患者达到血清AAT水平的正常化。赛诺菲将以每股30.0美元的现金价格收购Inhibrx的所有流通股份，整个交易的股权价值约为17亿美元（完全稀释后基础）。此外，赛诺菲将负责偿还Inhibrx当前的第三方债务，并在New Inhibrx保留8%的股权。INBRX-101已经成功完成了I期临床试验，并在安全性和药代动力学方面显示出积极结果，目前正在进行II期临床试验以进一步评估其作为AATD治疗的潜力。交易条款还包括，赛诺菲股东将获得New Inhibrx公司0.25股股份，并在药物达到关键监管里程碑时额外获得每股5美元的奖金。此次收购预计将在2024年第二季度完成，并将以赛诺菲可用的现金资源进行融资。此外，Inhibrx的其他实验性药物将被分拆到一个独立的公司中，由Inhibrx的首席执行官和创始人Mark Lappe领导，并保留Inhibrx的名称。赛诺菲将向这家分拆公司投资2亿美元现金，并持有该公司8%的股份。赛诺菲的此次收购支持了其在罕见病和炎症免疫领域的地位，并与其在这些领域的30年传统相辅相成。赛诺菲的全球医疗团队致力于将科学奇迹转化为改善人们生活的治疗方法，通过提供潜在的改变生命的治疗选择和挽救生命的疫苗保护，为全球数百万患者服务。此次收购还需满足包括完成New Inhibrx分拆交易以及其他惯例成交条件，如获得监管机构批准和Inhibrx股东的批准。赛诺菲和Inhibrx董事会一致批准了该交易，预计将在2024年第二季度完成。19      宣布时间：1/17/24       收购方：Sun Pharma       被收购方：Taro Pharmaceutical       交易总金额：3.478亿美元Sun Pharmaceutical Industries Ltd.（Sun Pharma）已经宣布与Taro Pharmaceutical Industries Ltd.（Taro）达成最终合并协议，根据该协议，Sun Pharma将收购Taro的所有流通股份，除了Sun Pharma及其关联公司已经持有的股份。此次交易中，Taro的每股收购价格为43.00美元，全部以现金支付。Sun Pharma目前是Taro的控股股东，持有Taro约78.48%的股份，此次收购将涉及支付约3.48亿美元，用于购买剩余的约808万Taro股份。Sun Pharma计划利用内部积累和之前募集的资金来资助这次收购。此次收购的完成预计将在2024年上半年进行，但须满足包括获得Taro股东批准、监管许可以及其他惯例的交易完成条件。完成后，Taro将成为Sun Pharma的全资子公司，并将从纽约证券交易所退市。Sun Pharma对Taro的收购意向可以追溯到多年前，经过多年的谈判和尝试，这次最终协议的达成标志着这场长期并购的完成。Sun Pharma表示，Taro在Sun的战略干预下，一直是仿制皮肤科药物市场的关键参与者，并且在完成合并后，合并后的实体将利用其全球实力和能力更好地服务患者和医疗保健专业人士的需求。Taro的特别委员会在独立财务和法律顾问的协助下，全面评估了Sun Pharma的提案，并确定合并协议和每股合并对价对Taro及其少数股东是公平的，符合他们的最佳利益。此外，Taro将向美国证券交易委员会（SEC）提交一份包含合并协议的6-K表格形式的当前报告，并在交易相关文件准备完成后向股东发送包含合并协议副本的代理声明书。这次收购是Sun Pharma加强其在全球制药市场地位的战略举措，特别是通过增加在皮肤科药物领域的业务和产品线。20      宣布时间：1/9/24       收购方：GSK       被收购方：Aiolos Bio       交易总金额：14亿美元葛兰素史克公司（GSK）宣布完成了对Aiolos Bio公司的收购。Aiolos Bio是一家临床阶段的生物制药公司，专注于解决患有某些呼吸道和炎症性疾病的患者未满足的治疗需求。根据协议，此次收购包括高达10亿美元的预付款和高达4亿美元的监管里程碑付款。Aiolos Bio的主要候选产品AIO-001是一种抗胸腺基质淋巴细胞生成素（TSLP）单克隆抗体，由于其半衰期延长和差异化效力，有可能延长给药间隔，例如每6个月一次。AIO-001与TSLP配体结合，能够抑制TSLP信号传导，TSLP在驱动炎症（包括哮喘）方面具有经过验证的核心作用。GSK首席科学官Tony Wood表示，AIO-001的早期研究已显示出在健康志愿者和哮喘患者中的初步安全性、耐受性、药代动力学和生物活性。此外，由于其增强的效力和半衰期延长技术，AIO-001有潜力每六个月给药一次，这可能重新定义标准护理。此次收购使GSK能够获得Aiolos的AIO-001，GSK还将负责向恒瑞支付基于成功的里程碑式付款以及分级版税。AIO-001是由江苏恒瑞制药有限公司研发的独家专利，Aiolos Bio于2023年8月从恒瑞医药获得了该药物在大中华区以外的全球开发和商业化的独家授权。GSK在开发促进呼吸系统疾病管理的药物方面拥有50年的经验，此次收购将扩大GSK的呼吸产品组合，为3.15亿哮喘患者提供更广泛生物制剂的选择，包括那些T2炎症水平较低的患者。Aiolos Bio首席执行官Khurem Farooq表示，他们相信此次交易说明了他们的长效抗TSLP单克隆抗体AIO-001的巨大潜力，通过与GSK合作，他们有信心能够迅速推进这种疗法，以期显著减轻患者的治疗负担。此次收购的完成预计将在2024年上半年进行，但须满足包括获得监管许可以及其他惯例的交易完成条件。收购完成后，Aiolos Bio将成为GSK的一部分，其产品和管线将被纳入GSK的研发组合中。21      宣布时间：1/8/24       收购方：J&J       被收购方：Ambrx Biopharma       交易总金额：20亿美元强生公司（Johnson & Johnson，简称J&J）宣布已达成收购Ambrx Biopharma的最终协议。Ambrx Biopharma是一家临床阶段的生物制药公司，专注于利用其专有的合成生物学技术平台来设计和开发下一代抗体偶联药物（ADC）以及其他调节免疫系统的疗法。根据协议，强生将以每股28美元的现金收购Ambrx的所有已发行股票，整个交易的总股本价值约为20亿美元。此次全现金合并交易的总股本价值约为20亿美元，扣除预计收购现金后净值为19亿美元。Ambrx的管线中包括多个临床和临床前项目，其中ARX517是一种针对前列腺特异性膜抗原（PSMA）的ADC，用于治疗转移性去势抵抗性前列腺癌（mCRPC）。ARX788是另一种ADC，针对人表皮生长因子受体2（HER2），用于治疗转移性HER2+乳腺癌。此外，还有ARX305，这是针对II型跨膜蛋白（CD-70）的ADC，用于治疗肾细胞癌。强生计划与Ambrx的研究人员合作，加速ARX517治疗晚期前列腺癌的I/II期APEX-01研究，并推进一系列新颖的候选产品。此次收购预计将于2024年上半年完成，交易完成后，Ambrx的普通股将不再在纳斯达克全球精选市场上市交易。通过此次收购，强生公司旨在推进其在肿瘤学领域的创新，并利用Ambrx的技术平台来设计、开发和商业化新的肿瘤靶向治疗药物，以期改变癌症的治疗方法并改善患者的生活。22      宣布时间：1/8/24       收购方：Merck & Co.       被收购方：Harpoon Therapeutics      交易总金额：6.8亿美元默克公司（Merck & Co., Inc., 简称Merck，在美国和加拿大以外称为MSD）宣布已与Harpoon Therapeutics, Inc.（纳斯达克股票代码：HARP）达成最终协议，根据该协议，默克将通过其子公司以每股23.00美元的现金收购Harpoon Therapeutics，股权总价值约为6.8亿美元。Harpoon Therapeutics是一家临床阶段的免疫疗法公司，专注于开发新型T细胞接合生物制剂，其基于抗体的新型药物发现平台TriTAC®（Tri-specific T cell Activating Construct），旨在通过激活T细胞来释放患者自身免疫系统靶向性的细胞杀伤特性。默克公司预计将记录约6.5亿美元的费用，即每股约0.26美元，该费用将计入交易完成当季度的非GAAP业绩中。Harpoon董事会一致批准了本次交易，并预计将于2024年上半年完成。此次收购将作为资产收购进行会计处理，有助于默克公司进一步多样化其肿瘤学产品线，并推进突破性科学以满足全球癌症患者的需求。默克公司通过此次收购将获得Harpoon的TriTAC®平台和ProTriTAC™平台，后者采用了前药概念，设计为在到达肿瘤之前保持非活性状态的治疗性T细胞接合剂。此外，默克公司还提到了完成交易的一系列条件，包括Harpoon股东的批准、哈特-斯科特-罗迪诺反垄断改进法案等待期的到期以及其他惯常条件。默克公司强调，此次收购将有助于公司在全球范围内推进其肿瘤学产品线的发展，并为患者提供创新的治疗方案。收购完成后，Harpoon Therapeutics将成为默克公司的一部分，其产品和管线将被纳入默克的研发组合中。23      宣布时间：1/8/24       收购方：Novartis      被收购方：Calypso Biotech       交易总金额：4.25亿美元诺华（Novartis）已宣布与Calypso Biotech达成收购协议。根据协议，诺华将斥资约4.25亿美元收购Calypso Biotech，其中包括2.5亿美元的预付款和高达1.75亿美元的开发里程碑付款。Calypso Biotech是一家专注于研发用于治疗多种自身免疫性疾病的单克隆抗体的生物技术公司，特别是在IL-15生物学方面具有专长。IL-15是一种涉及组织稳态和炎症的细胞因子，其表达的失调通过激活免疫细胞介导组织炎症和破坏。诺华通过此次收购将获得Calypso Biotech的主要候选药物CALY-002的全部权利。CALY-002是一种潜在的“best-in-class”治疗性抗体，它结合并中和IL-15，目前正在1b期临床试验中评估其对乳糜泻（Celiac Disease）和嗜酸性食管炎（Eosinophilic Esophagitis）患者的治疗效果。诺华计划在众多有着巨大未满足医疗需求的自身免疫性疾病中进一步探索CALY-002的应用。此次收购使诺华能够利用Calypso Biotech在IL-15生物学方面的专业知识，推进其在免疫学领域的研究和开发工作。Calypso Biotech是默克（Merck）的一个衍生公司，专注于将IL-15生物学转化为医学突破。此次交易的完成将使CALY-002作为诺华产品线的一部分，有望为自身免疫疾病患者提供新的治疗选择。Calypso Biotech的首席执行官兼联合创始人Alain Vicari表示，作为诺华产品组合的一部分，CALY-002将处于最佳位置，以便有效开发，从而能够迅速满足多个适应症中未得到满足的医疗需求。此次收购的完成预计将在满足包括获得监管许可以及其他惯例的交易完成条件后进行。24      宣布时间：1/5/24       收购方：Novartis       被收购方：SanReno Therapeutics（信瑞诺）      交易总金额：35亿美元诺华（Novartis）已经成功完成了对信瑞诺医药（SanReno Therapeutics）的收购。信瑞诺医药是一家临床阶段的公司，专注于开发治疗肾脏疾病的创新疗法，特别是在IgA肾病（IgAN）领域。通过这次收购，诺华不仅加强了其在中国市场的承诺，而且在全球肾脏健康领域也占据了重要地位。信瑞诺医药的创新产品线中，两个关键资产是Atrasentan和Zigakibart，两者都针对IgAN。Atrasentan是一种口服内皮素A受体拮抗剂（ERA），已经进入3期临床开发阶段，显著降低了蛋白尿，这是肾脏疾病研究中的关键终点。Zigakibart（BION-1301）是一种皮下注射的抗APRIL单克隆抗体，已获得中国药品审评中心（CDE）的批准，开始进行3期研究。这次收购在信瑞诺医药成立后的前两年内完成，标志着一个中国生物技术公司被一家跨国制药公司收购的历史性时刻，展示了中国在全球医疗保健领域日益增长的重要性。这次战略收购加强了诺华在肾脏疾病治疗方面的承诺，并补充了其现有的肾脏疾病产品线。信瑞诺医药首席执行官郝浩宇（Haoyu Huang）对这次收购表示热情，他说：“诺华对信瑞诺的收购证明了信瑞诺团队不懈的奉献和不懈的创新精神。这验证了我们推进肾脏疾病治疗边界的承诺。我们很高兴与全球制药领导者诺华联手，共同致力于为中国及全球肾脏疾病患者带来潜在的变革性药物。今天标志着我们在肾脏健康领域产生有意义影响的旅程中激动人心的新篇章。”通过这次收购，诺华将获得信瑞诺的产品线和能力，包括大中华区和新加坡的独家权利。这笔交易反映了诺华对中国市场的承诺，并补充了其在肾脏疾病领域的现有产品线。附：24笔交易汇总表版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn推荐阅读Q1财报之后，减肥药格局再变！2024年至今：24笔并购（M&A）交易，总金额520.2亿美元，单笔金额都远低于2023年数量缩减！2024年阿尔茨海默病在研管线分析点击阅读原文，了解更多！