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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 311 drug applications between 18 November 2024 and 24 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 80 drug names.

2024/11/18 – 2024/11/24

Period
2024/11/18 to 2024/11/24, 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
311
Drugs with new generic filings (by drug name, de-duplicated)
80
Accepted this week, now under review
4

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

311filings, 99 of them generic

By application type

Application typeFilings
Supplement120
Generic99
New drug57
Import15
Unspecified10
Import re-registration10

By drug type

Drug typeFilings
Chemical drug232
Therapeutic biologic43
TCM32
Prophylactic biologic4

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

80 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Adapalene Gel3330
3Sodium Valproate Sustained-release Tablets(I)224
4西甲硅油乳剂 · No verified English name223
5双氯芬酸钠贴剂 · No verified English name210
6Lamotrigine Tablets210
7注射用阿立哌唑 · No verified English name214
8Buspirone Hydrochloride Tablets215
9Metformin Hydrochloride Oral Solution213
10Lidocaine Hydrochloride Topical Solution210

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

200 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized1360
2Heilongjiang Sheng Fu Le Kang Pharma Co., Ltd. romanized650
3Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized610
4Novo Nordisk A/S510
5Wan Bang De Pharmaceutical Group Co., Ltd. romanized440
6Chongqing Xi Er An Pharma Co., Ltd. romanized440
7Shanxi Tong Da Pharma Co., Ltd. romanized432
8Qilu Pharmaceutical Co., Ltd.432
9Amgen Inc.420
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD420

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

109 this week

AcceptedDrugApplicants
2024/11/23Import · Class 2.2 罗莫索珠单抗注射液 · No verified English nameJXSL2400227 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2024/11/23Import · Class 1 输注用无菌冻干粉Telisotuzumab vedotin · No verified English nameJXSL2400226 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/11/23Generic · Class 3 Betamethasone Sodium Phosphate InjectionCYHS2404040 Anhui Mei Lai Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized
2024/11/23Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2404034 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2024/11/23Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2404033 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2024/11/23Generic · Class 3 Terlipressin Acetate InjectionCYHS2404027 Chengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanized
2024/11/23Generic · Class 3 Tranexamic Acid and Sodium Chloride InjectionCYHS2404023 Hubei Jin Yao Pharma Co., Ltd. romanized
2024/11/23Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2404018 Jewim Pharmaceutical (Shandong) Co., Ltd.
2024/11/23Generic · Class 3 Buspirone Hydrochloride TabletsCYHS2404017 Jewim Pharmaceutical (Shandong) Co., Ltd.
2024/11/23Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHL2400234 Beijing Han Mei Medicines Co., Ltd. romanized
2024/11/23Generic · Class 3 双氯芬酸钠贴剂 · No verified English nameCYHL2400233 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/11/23Generic · Class 3 双氯芬酸钠贴剂 · No verified English nameCYHL2400232 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/11/23New drug · Class 2.2 ZY-A001 · No verified English nameCXZL2400079 Ya Bao Pharma Group Co., Ltd. romanized
2024/11/23New drug · Class 1 伊诺格鲁肽注射液 · No verified English nameCXSS2400129 Hangzhou Xian Wei Da Bio Technology Co., Ltd. romanized; Mei Yao Xing (Nanjing) Pharmaceutical Co., Ltd. romanized
2024/11/23New drug · Class 3.3 利妥昔单抗注射液 · No verified English nameCXSS2400128 Hua Lan An Kang Bio Co., Ltd. romanized
2024/11/23New drug · Class 3.3 利妥昔单抗注射液 · No verified English nameCXSS2400127 Hua Lan An Kang Bio Co., Ltd. romanized
2024/11/23New drug · Class 1 BA1106注射液 · No verified English nameCXSL2400796 Shandong Bo An Bio Technology Co., Ltd. romanized
2024/11/23New drug · Class 2.2 LY01015注射液 · No verified English nameCXSL2400795 Shandong Bo An Bio Technology Co., Ltd. romanized
2024/11/23New drug · Class 2.2 LY01015注射液 · No verified English nameCXSL2400794 Shandong Bo An Bio Technology Co., Ltd. romanized
2024/11/23New drug · Class 1 AWT020注射用无菌粉末 · No verified English nameCXSL2400793 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2024/11/23New drug · Class 1 注射用BL-M07D1 · No verified English nameCXSL2400792 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/11/23New drug · Class 1 QB0208-1胶囊 · No verified English nameCXHL2401276 Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized
2024/11/23New drug · Class 1 QB0208-1胶囊 · No verified English nameCXHL2401275 Beijing Qing Bo Hui Neng Pharmaceuticals Technology Co., Ltd. romanized
2024/11/23New drug · Class 1 TQB3912片 · No verified English nameCXHL2401274 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/11/23New drug · Class 1 TQB3720片 · No verified English nameCXHL2401273 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/11/22Import · Class 3.1 特泽利尤单抗注射液 · No verified English nameJXSS2400103 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2024/11/22Import · Class 3.1 特泽利尤单抗注射液 · No verified English nameJXSS2400102 AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd.
2024/11/22Import · Class 1 MK-7240注射液 · No verified English nameJXSL2400225 Merck Sharp & Dohme LLC; Name not romanized
2024/11/22Generic · Class 3 盐酸尼卡地平氯化钠注射液 · No verified English nameCYHS2404016 Zhejiang Guo Jing Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/11/22Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2404015 HAINAN HUALON PHARMACEUTICAL CO.,LTD

79 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.

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