YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 413 drug applications between 18 May 2023 and 24 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 45 drug names.

2023/05/18 – 2023/05/24

Period
2023/05/18 to 2023/05/24, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
413
Drugs with new generic filings (by drug name, de-duplicated)
45
Accepted this week, now under review
3

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

413filings, 72 of them generic

By application type

Application typeFilings
Supplement243
Generic72
New drug67
Import re-registration16
Import10
Unspecified5

By drug type

Drug typeFilings
Chemical drug295
TCM73
Therapeutic biologic41
Prophylactic biologic3
Biologic1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

45 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Roxadustat Capsules8417
2Naloxone Hydrochloride Injection421
3Ropivacaine hydrochloride injection415
4Sildenafil Citrate Tablets3112
5Carfilzomib For Injection310
6Oxacillin Sodium for Injection3113
7Indobufen Tablets226
8氧(液态) · No verified English name2213
9Phloroglucinol Injection222
10Nicorandil for Injection211

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized37360
2Hubei Lang De Pharma Co., Ltd. romanized34160
3Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized24110
4Ping Guang Pharmaceutical Co., Ltd. romanized14140
5UCB Pharma SA610
6Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized610
7Guang Sheng Yuan Zhong Pharmaceuticals Co., Ltd. romanized530
8Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized440
9Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized424
10Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized421

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

104 this week

AcceptedDrugApplicants
2023/05/24Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2301409 Haerbin Kui Hua Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Tang Shan) Biopharmaceutical Co., Ltd. romanized
2023/05/24Generic · Class 3 Diprophylline InjectionCYHS2301408 Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/05/24Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2301406 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/05/24Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2301405 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/05/24Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301404 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/05/24Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301403 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/05/24Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301402 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/05/24New drug · Class 3.3 帕妥珠单抗注射液 · No verified English nameCXSS2300038 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/05/24New drug · Class 1 注射用BRII-877(VIR-3434) · No verified English nameCXSL2300371 Teng Sheng Bo Yao Pharmaceuticals Technology (Beijing) Co., Ltd. romanized
2023/05/24New drug · Class 1 FT-003注射液 · No verified English nameCXSL2300370 Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized
2023/05/24New drug · Class 1 RC148注射液 · No verified English nameCXSL2300369 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/05/24New drug · Class 1 BN104片 · No verified English nameCXHL2300577 Ye Hui Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/05/24New drug · Class 1 BN104片 · No verified English nameCXHL2300576 Ye Hui Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/05/24New drug · Class 1 HTMC0435片 · No verified English nameCXHL2300573 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/05/24New drug · Class 1 HTMC0435片 · No verified English nameCXHL2300572 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/05/24New drug · Class 1 HTMC0435片 · No verified English nameCXHL2300571 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/05/24New drug · Class 1 HTMC0435片 · No verified English nameCXHL2300570 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/05/24New drug · Class 1 HTMC0435片 · No verified English nameCXHL2300569 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/05/24New drug · Class 1 HTMC0435片 · No verified English nameCXHL2300568 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2023/05/24New drug · Class 1 ASC60片 · No verified English nameCXHL2300567 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2023/05/24New drug · Class 1 ASC60片 · No verified English nameCXHL2300566 Ge Li Bio Technology (Hangzhou) Co., Ltd. romanized
2023/05/23Generic · Class 3 Nicorandil for InjectionCYHS2301394 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/05/23Generic · Class 3 Nicorandil for InjectionCYHS2301393 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/05/23Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2301390 Bai Shan Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2023/05/23Generic · Class 3 Methocarbamol InjectionCYHS2301383 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 Minoxidil Topical SolutionCYHS2301380 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301378 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2301377 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2301371 Nanjing Chuang Di Bio Technology Co., Ltd. romanized; Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2023/05/23Generic · Class 3 Acetylcysteine Oral SolutionCYHS2301370 Anhui Mao Kang Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized

74 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.