HONG KONG, Aug 13, 2021 – (ACN Newswire) – TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Group"; stock code: 1875.HK), a biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, announced today its unaudited interim results for the six months ended 30 June 2021.
KLJUČNI MEJNIKI V LETU 2021 1H
V prvi polovici leta 2021 je na podlagi nacionalnih politik in na podlagi inovativnih raziskav in razvoja trg onkoloških zdravil na Kitajskem doživel razmah in še naprej pridobival zagon. Skupina je nadaljevala z uresničevanjem strateških načrtov s črpanjem lastnih moči in konkurenčnih prednosti ter si prizadevala postati vodilni igralec na domačem trgu ADC. Skupina je pospešila raziskave in razvoj zdravil ADC in industrijsko načrtovanje ter izkoristila tržne priložnosti, kar ji je omogočilo preboj na področju inovativnih zdravil CDMO/CMO.
Odobritev za dva izdelka, ki se lansirata na trg:
— TOZ309 (temozolomide capsules) was approved for launch in China by the NMPA in May 2021. It is a first-line medication for newly diagnosed and recurrent glioma as well as recurrent anaplastic astrocytoma. TOZ309 is the first self-developed chemical drug of TOT BIOPHARM. Together with other pharmaceutical companies in China to hasten market penetration of the product. It will at the same time prepare for renewal of the fourth round of drugs for centralized procurement in China in 2022.
— TOM218 (Megaxia(R) – megestrol acetate oral suspension) is imported by the Group, it owns the exclusive agency of the drug in mainland China, Hong Kong and Macau. The drug can alleviate the cachexia status of AIDS and cancer patients, including loss of appetite and body weight, and nausea and vomiting that sometimes occur. Compared to the solid dosage forms, oral suspensions can reduce the discomfort of patients in swallowing. Megaxia(R) had been approved for sale in the United States in 2014 and is the first high concentration megestrol acetate oral suspension approved for sale in China.
Glavni mejniki ključnih izdelkov v kliničnem preskušanju
— Core product TAB008 – Application for Marketing Approval Submitted and Being Processed: TAB008 is a bevacizumab biosimilar self-developed by TOT BIOPHARM for treating malignant tumors including advanced, metastatic and recurrent NSCLC and metastatic colorectal cancer. The new drug application (NDA) of TAB008 was filed in September 2020 and currently being processed by NMPA, which completed an on-site inspection and GMP-compliance inspection in January 2021. the Group expects to receive approval for marketing of the drug by end of 2021. As bevacizumab covers a number of cancers common in China, market demand would be huge.
— TAA013 – Smooth Progress of Phase III Clinical Trial: TAA013 is an ADC candidate containing trastuzumab and an emtansine derivative (Trastuzumab-MCC-DM1) for treating advance-stage or metastatic HER2+ breast cancer which could not be cured by trastuzumab and be surgically removed. In July 2020, the drug was given to the first patient in the Phase III clinical trial. To date, over 70 clinical research centers in the country are involved in the Phase III clinical trials making satisfactory progress.
Ključni mejniki komercialnega načrtovanja proizvodnje
— In the first half of 2021, TOT BIOPHARM actively deployed for ADC pilot production and commercial production. It has put together highly competitive GMP-compliant pilot production facilities for mAb and ADC liquid formulation and drug substance, including the OEB-5 potency-level freeze-dried powder/liquid injection formulation (Capacity of ADC drug substance: 1g~300g/batch; Capacity of ADC formulation line: 500~5,000 vials/batch) and a GMP-compliant ADC commercial production workshop (Capacity of ADC drug substance: 1,000g-3,000g/batch; Capacity of ADC formulation line: 10,000~15,000 vials/batch).
Izrazita konkurenčnost zdravil ADC
TOT BIOPHARM ima osnovne tehnologije procesa konjugacije, popolno tehnološko platformo za analizo ADC in zmožnosti neodvisne analize glede kritičnih metričnih atributov ADC. Skladno s tem smo dosegli tehnični preboj pri regulaciji glikoform, ki omogoča natančno kontrolo sestave vsake glikoforme. Zagotavlja uspešen razvoj procesov ADC in proizvaja visoko kakovost izdelkov.
TOT BIOPHARM je ustanovil strokovno skupino za raziskave in razvoj tehnologij konjugacijskih procesov ADC in analitično ekipo za kompleksno strukturo molekule ADC. Ponašajo se z njihovimi obsežnimi praktičnimi izkušnjami, uspešnimi zglednimi primeri in njihovimi celovitimi izkušnjami, ki segajo od raziskav in razvoja, razvoja procesov, kliničnih preskušanj, registracije in vložitve za odobritev do komercialne proizvodnje, naši izdelki pa so na vodilnem položaju med ADC-ji na Kitajskem.
POSLOVANJE CDMO/CMO DOSEŽE PRESKOČNI PREBOJ
Zasnovana inovativna rešitev CDMO za zdravila na enem mestu
Kljub močni konkurenci v biomedicinskem sektorju je TOT BIOPHARM uspel učinkovito izkoristiti tržne priložnosti in s polnim izkoriščanjem svoje odprte tehnološke platforme in zmogljivosti komercialne proizvodnje je pospešil razvoj svojega lokaliziranega CDMO na enem mestu. CMO poslovanje, zlasti v sektorju ADC. Sposoben je ujeti prve priložnosti na trgu in zagotoviti priložnosti za sodelovanje.
— TOT BIOPHARM owns core conjugation process technologies and has the ability to scale up technologies. With that advantage and capable of independent analysis of ADC critical metric attributes, the Group can guarantee the high quality of its product R&D work.
— It possesses "perfusion-batch hybrid technology" that can support commercial production of mAb drugs, including scaling up production from 25L to 2,000L directly, helping simplify the production process and shorten the production cycle, in turn enhance markedly the economic return of commercial CDMO/CMO projects.
— Priding long-term trusting relationship with partners, the Group took on various new CDMO/CMO projects in the first half of 2021, and saw substantial increase in terms of number of partners and business scale with the relevant revenue recording a substantial year-on-year growth of 330%.
— Being able to complete all the stages from R&D to putting out the end products in one plant and one place within the same production base at its Suzhou headquarter, TOT BIOPHARM managed to reduce much of the risks and difficulties in management, transportation and technological from outsourcing different procedures to different suppliers.
Okrepljeno sodelovanje in izmenjava
TOT BIOPHARM neguje svoje dolgoročne odnose in različne vrste sodelovanja z različnimi partnerji ter s ciljem povečati konkurenčnost jedra CDMO storitev.
— On 19 July, TOT BIOPHARM and BrightGene Bio-Medical Technology Co., Ltd. (688166.SH) became strategic cooperation partners, which has seen its one-stop for ADC drug CDMO service platform strengthen in favor of R&D and commercialization of innovative drugs. Pursuant to the agreement, the two parties will work together to provide clients with services starting with development of production craftsmanship, moving on to scaling up production and eventually GMP-compliant production. The cooperation realized seamless connection of industrial chains, removing the risks from cross-regional regulation, and is a marriage of strengths in terms of technologies and resources, allowing further upgrade of the CDMO service platform for ADC drugs to provide one-stop solutions to innovative drug corporations to help them reduce R&D risks and make commercialization more efficient.
OSNOVNE POSLOVNE PREDNOSTI
TOT BIOPHARM je razvil tri ključne poslovne prednosti, ki predstavljajo trdne temelje za razvoj in sodelovanje na področju inovativnih zdravil.
— Three Technology Platforms and Comprehensive Industrial Value Chain
TOT BIOPHARM ima tri integrirane tehnološke platforme in preizkušen mednarodni sistem za upravljanje in registracijo kakovosti ter ekipo za registracijo ter celovito industrijsko vrednostno verigo, ki zajema od raziskav in razvoja, razvoja procesov, kliničnih preskušanj, registracije in vložitve do komercialne proizvodnje, kar mu daje trdne temelje za pospešiti raziskave in razvoj, določiti prisotnost na mednarodnem trgu in za svoje poslovanje CDMO/CMO.
— A Packed Product Pipeline with Huge Market Potential
Trenutno ima skupina v načrtu 12 kandidatov za zdravila, vključno z zdravili z monoklonskimi protitelesi, kot so TAB008 (mAb proti VEGF), TAB014 (mAb proti VEGF) in TAY018 (mAb proti CD47) ter ADC, kot je TAA013 (mAb proti -HER2 ADC), za indikacije, ki vključujejo različne vrste raka z visoko incidenco, kot so nedrobnocelični pljučni rak, rak dojke, rak želodca, rak možganskega glioma in rak materničnega vratu.
— Rare Capability of Commercially Producing mAb and ADC
Strinjajoč se z industrijsko nadgradnjo družbe in za izpolnjevanje povpraševanja na trgu, je skupina leta 2021 začela s prizadevanji za razširitev proizvodnih zmogljivosti in še naprej krepila komercialno proizvodno zmogljivost svojih zdravil protiteles in izdelkov ADC, da bi se pripravila na nenehno širitev CDMO/ CMO poslovanje. V skladu s strateškim načrtom bomo še naprej širili proizvodne zmogljivosti mAb zdravil na več kot 16,000 L.
Prihodnji razvoj
Dr. Liu Jun, glavni izvršni direktor, glavni znanstveni uradnik in izvršni direktor TOT BIOPHARM, je dejal: "Pričakujemo, da bo TAB008, naše prvo biološko zdravilo, odobreno za lansiranje na trg leta 2021, zato bomo sodelovali z velikimi farmacevtskimi obrati za uvedli naš načrt trženja. Hkrati bomo pospešili klinične postopke ADC TAA013, da bi obogatili nabor izdelkov ADC. Z biološkimi zdravili CDMO na Kitajskem na splošno cvetijo, izkoristite našo prednost "enoosnovnega" CDMO/ Vrednostna veriga CMO, bomo svoje vire namenili optimizaciji poslovanja CDMO na področju ADC, okrepili podobo naše blagovne znamke in utrdili svoj položaj na trgu.
»V prihodnje verjamemo, da bodo konkurenčne prednosti TOT BIOPHARM vedno bolj očitne. Zaposlenim bomo še naprej zagotavljali veliko prostora za razvoj, partnerjem pa z najboljšimi strateškimi rešitvami, delničarjem pa ustvarjali vrednost.«
FINANČNI POUDARKI (na dan 30. junija 2021)
Ukrepi hongkonških standardov računovodskega poročanja:
— Revenue was RMB23.132 million, representing a year-on-year growth of 78% thanks to the Group's proactive expansion of CDMO/CMO business heeding market changes, with relevant revenue up year-on-year growth by a substantial 330%.
— R&D expenses were RMB88.749 million, representing a year-on-year decrease of 11%, mainly attributable to the completion of Phase III clinical trials for the TAB008 project in the second half of 2020, which resulted in a year-on-year decrease in costs of clinical trials, also, R&D work completed for the TOZ309 project, there was a significant reduction of relevant expenses on R&D consumables.
— Selling expenses were RMB11.202 million, representing a year-on-year decrease of 18%, mainly attributable to the Company's sales strategy adjustments, resulting in reduction of relevant costs and expenses.
— General and administrative expenses were RMB26.823 million, representing a year-on-year increase of 11%, mainly attributable to the increase in operating and management expenses related to related to employee, administration and taxation, etc..
— The above mentioned all in account, net loss of the Group for the first half of 2021 reached RMB115.005 million, representing a year-on-year decrease of 11%.
Avtorske pravice 2021 ACN Newswire. Vse pravice pridržane. www.acnnewswire.comTOT BIOPHARM International Company Limited ("TOT BIOPHARM" ali "skupina"; borzna koda: 1875.HK), biofarmacevtsko podjetje, namenjeno razvoju in trženju inovativnih onkoloških zdravil in terapij, je danes objavilo svoje nerevidirane vmesne rezultate za šest mesecev, ki se je končalo 30. junija 2021. Vir: https://www.acnnewswire.com/press-release/english/68654/
- 000
- 2020
- Račun
- Prednost
- Sporazum
- pomoč
- Usmerjanje
- vsi
- Dovoli
- med
- Analiza
- razglasitve
- apetit
- uporaba
- BEST
- telo
- poslovni
- kapaciteta
- primeri
- kemijske
- šef
- izvršni direktor
- Kitajska
- kliničnih preskušanj
- Koda
- komercialna
- Skupno
- Podjetja
- podjetje
- Tekmovanje
- koncentracija
- avtorske pravice
- Korporacije
- stroški
- Povpraševanje
- Razvoj
- Direktor
- vozi
- drog
- Droge
- Gospodarska
- Zaposleni
- Ekskluzivno
- izvršni
- Izvršni direktor
- Razširi
- širi
- Širitev
- pričakuje
- Stroški
- izkušnje
- finančna
- prva
- Naprej
- polno
- splošno
- Giving
- skupina
- Rast
- visoka
- Hong Kong
- HTTPS
- velika
- Hybrid
- slika
- Vključno
- Povečajte
- industrijske
- Facebook Global
- vključeni
- IT
- julij
- Ključne
- velika
- kosilo
- vodi
- Vzvod
- Limited
- vrstica
- Tekočina
- Izdelava
- upravljanje
- Tržna
- Trženje
- milijonov
- Momentum
- mesecev
- net
- Častnik
- odprite
- deluje
- Priložnosti
- Ostalo
- partnerji
- Farmacevtska
- pilot
- načrtovanje
- platforma
- Platforme
- predvajalnik
- politike
- predstaviti
- Izdelek
- proizvodnja
- Izdelki
- Projekt
- projekti
- kakovost
- R & D
- zmanjša
- registracija
- Uredba
- Raziskave
- viri
- Rezultati
- prihodki
- Roll
- prodaja
- prodaja
- Lestvica
- skaliranje
- Znanost
- brezšivne
- Izkoristite
- Storitve
- SIX
- rešitve
- hitrost
- standardi
- Države
- Status
- zaloge
- Strateško
- Strategija
- predložen
- snov
- uspešno
- podpora
- sistem
- Obdavčitev
- tehnični
- Tehnologije
- Tehnologija
- čas
- Prevoz
- zdravljenje
- sojenje
- Velika
- Združene države Amerike
- vrednost
- v
- delo