Breaking
TRBlood-chilling moments during the live broadcast: Ecuadorian priest lost his lifeDETragedy before a football game – soldier falls from the hall ceiling onto the field and diesBRDriver dies after car collides head-on with truck on RS-118ITTennis: Svitolina and Monfils break up, the champions' marriage endsBRRio starts the week with cloudy skies and rain; see the forecast for the weekTRCountdown for mutual recognition with the EU at customs for "Authorized Economic Operator Status"ESCatalonia asks that children stay in schools this afternoon if it rains a lotCNChina optimizes and adjusts export control measures for drone-related itemsINTLHow a grass fire at a Canadian military base killed four soldiersKR'Korea's first gold medal' shooting Seo Hoon-tae "I'm happy as if I won two gold medals"TRBlood-chilling moments during the live broadcast: Ecuadorian priest lost his lifeDETragedy before a football game – soldier falls from the hall ceiling onto the field and diesBRDriver dies after car collides head-on with truck on RS-118ITTennis: Svitolina and Monfils break up, the champions' marriage endsBRRio starts the week with cloudy skies and rain; see the forecast for the weekTRCountdown for mutual recognition with the EU at customs for "Authorized Economic Operator Status"ESCatalonia asks that children stay in schools this afternoon if it rains a lotCNChina optimizes and adjusts export control measures for drone-related itemsINTLHow a grass fire at a Canadian military base killed four soldiersKR'Korea's first gold medal' shooting Seo Hoon-tae "I'm happy as if I won two gold medals"
Newsgather
All StoriesWorldSportsFinanceTechScienceHealthCultureClimatePoliticsSpace
BackTLC-KY, a new long-acting analgesic drug successfully solved blindness and is expected to be launched in the United States as soon as the end of next year
TLC-KY, a new long-acting analgesic drug successfully solved blindness and is expected to be launched in the United States as soon as the end of next year
BREAKING
自由时报1 hour agoBusiness2 min readChinaView original

TLC-KY, a new long-acting analgesic drug successfully solved blindness and is expected to be launched in the United States as soon as the end of next year

tlc-kytlc590Unblinding

Quick Look

  • TLC-KY, a new drug R&D company in Xinggui, announced that its new long-acting post-operative analgesic drug TLC-KY has successfully unblinded the Phase III clinical trial, significantly reducing postoperative pain and reducing the use of opioids.
  • It is expected to apply to the US FDA for new drug marketing in the first half of next year.

AI-generated summary

Why It Matters

The preliminary analysis results of the Phase III clinical trial of TLC590 for hallux valgus surgery were released and successfully achieved the main efficacy indicators.

Font size

TLC-KY long-acting analgesic has successfully solved blindness and will apply for a drug license in the first half of next year. The third from the left in the picture is TLC-KY CEO Ye Zhihong. (Provided by TLC-KY)

[Reporter Chen Yongji/Taipei Report] TLC-KY (7924), a new drug research and development company in Xinggui, announced today that the preliminary analysis results of the Phase III clinical trial of its new postoperative long-acting analgesic drug TLC590 for hallux valgus surgery (commonly known as "big foot" surgery, a common foot surgery) have been released, and the main efficacy indicator has been successfully achieved (that is, the blindness has been successfully resolved).

The trial results show that compared with placebo, TLC590 can significantly reduce pain within 72 hours after surgery and reduce the use of opioid analgesics; even when directly compared with the current mainstream long-acting local anesthetic liposomal bupivacaine (Exparel®) in the US market, TLC590 also showed statistically significant advantages in two secondary efficacy indicators: analgesic effect and opioid analgesic dosage.

In addition, the overall pain control of TLC590 within 7 days (168 hours) after surgery was also significantly better than placebo and liposomal bupivacaine. This result highlights the dual potential of TLC590 to both sustain pain relief and reduce the use of opioid analgesics, and is expected to bring a new option for non-opioid postoperative pain management.

TLC-KY stated that the preliminary analysis results of this phase III, especially the significant advantages demonstrated by direct comparison with liposomal bupivacaine, have laid a solid clinical foundation for TLC590 and established a clear differentiated advantage in the postoperative pain market.

TLC-KY CEO Ye Zhihong said that TLC will complete all trial data analysis and clinical trial reports, and is expected to submit a new drug application (NDA) to the US FDA in the first half of next year. Based on the review period of 9 to 12 months, TLC590 is expected to be launched at the end of next year or early next year. The company is also preparing for commercialization simultaneously, hoping that TLC590 will benefit postoperative patients as soon as possible.

What to Watch

AI outlook — possibilities, not facts

  • Submit a new drug application (NDA) to the US FDA in the first half of next year

    Very likely · Within months

Open Questions

  • When will the final review results of the US FDA be released?
  • How will commercial sales perform in the future?

Related Topics

tlc-ky
PeopleYe ZhihongChen Yongji
OrganizationsTLC-KYUSFDA
PlacesUnited States
Topicstlc590UnblindingPhase III clinical trialNew drug research and developmentYe Zhihong
This article was originally published by 自由时报.

Related Stories

China optimizes and adjusts export control measures for drone-related items
Urgent·

China optimizes and adjusts export control measures for drone-related items

China's Ministry of Commerce, General Administration of Customs, and the Equipment Development Department of the Central Military Commission jointly issued an announcement on the 19th, announcing the optimization and adjustment of export control measures for drone-related items, which will be officially implemented from November 18, with the aim of safeguarding national security, fulfilling non-proliferation obligations, and ensuring the stability of the global industrial chain and supply chain.

中国新闻网
2 min read
(Economic Observer) China’s third quarter economic report presents five major highlights
Business·

(Economic Observer) China’s third quarter economic report presents five major highlights

The National Bureau of Statistics of China released economic data for the first three quarters on the 19th, with GDP growing by 4.6% year-on-year. The "Third Quarterly Report" presents five highlights: a rebound in quarterly GDP growth, rapid growth of new driving forces, gradual improvement in domestic demand, strong growth in foreign trade, and moderate price increases.

中国新闻网
5 min read
China imposes export controls on shield boring machines and other items
Urgent·

China imposes export controls on shield boring machines and other items

China's Ministry of Commerce and the General Administration of Customs jointly issued an announcement on the 19th, announcing that from November 18, export controls will be implemented on items with dual-use military and civilian properties such as shield machines, and control measures for dredger-related items will be optimized and adjusted to safeguard national security and fulfill international non-proliferation obligations.

中国新闻网
1 min read
Guangxi consolidates quality infrastructure to provide guarantee for China-ASEAN cross-border trade
Business·

Guangxi consolidates quality infrastructure to provide guarantee for China-ASEAN cross-border trade

Zhang Zhiwen, deputy secretary-general of Guangxi, said on the 19th that Guangxi has consolidated quality infrastructure in recent years, built 10 national-level and 39 autonomous region-level quality inspection centers, innovated the "AI + quality supervision" model, promoted the quality strategy, and provided technical support for China-ASEAN cross-border trade.

中国新闻网
3 min read
The central bank’s words cannot stop foreign capital from remittances! New Taiwan dollar loses 7 times in a row, Huiyin reveals the key to stopping depreciation
Developing·

The central bank’s words cannot stop foreign capital from remittances! New Taiwan dollar loses 7 times in a row, Huiyin reveals the key to stopping depreciation

Affected by the continued remittances of foreign capital, the exchange rate of the New Taiwan dollar against the U.S. dollar closed at 32.445 yuan on Monday, a depreciation of 1.07 cents, hitting a new low in nearly 18 months. Even though the central bank rarely called for stabilizing the exchange rate during the session, it was still unable to withstand the huge selling pressure, and the exchange rate fell seven times in a row.

自由时报
3 min read
China grew by 4.5% in the third quarter, but the hot and cold conditions were uneven: Exports surged, and the area of newly started construction in the property market plummeted
Developing·

China grew by 4.5% in the third quarter, but the hot and cold conditions were uneven: Exports surged, and the area of newly started construction in the property market plummeted

China announced that its GDP grew by 4.5% year-on-year in the third quarter, and the cumulative growth in the first three quarters was 4.6%. The economy is clearly experiencing "heat outside and cold inside", with exports and high-end manufacturing growing strongly. However, real estate investment has declined, new construction area in the housing market has dropped by 25%, and domestic consumption and overall investment remain weak.

BBC中文
7 min read
More on this topictlc-ky