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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 412 drug applications between 30 January 2024 and 5 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 127, covering 93 drug names.

2024/01/30 – 2024/02/05

Period
2024/01/30 to 2024/02/05, 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
412
Drugs with new generic filings (by drug name, de-duplicated)
93
Accepted this week, now under review
8

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

412filings, 127 of them generic

By application type

Application typeFilings
Supplement185
Generic127
New drug58
Import23
Unspecified10
Import re-registration9

By drug type

Drug typeFilings
Chemical drug278
Therapeutic biologic68
TCM52
Prophylactic biologic9
Biologic5

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

93 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment5152
2Vonoprazan Fumarate Tablets4260
3Lidocaine and Prilocaine Cream3324
4LevomilnacipranHydrochloride Extended-release Capsules316
5Diprophylline Injection227
6Tadalafil Tablets2223
7Gatifloxacin Eye Drops223
8Dronedarone Hydrochloride Tablets224
9Metoclopramide Hydrochloride Injection226
10Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution228

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

264 companies with new acceptances; top 10 listed

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

131 this week

AcceptedDrugApplicants
2024/02/05Import · Class 1 Livmoniplimab 注射液 · No verified English nameJXSL2400035 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/02/05Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSL2400034 Daiichi Sankyo Inc.; IQVIA RDS (Shanghai) Co. Ltd.
2024/02/05Generic · Class 3 Pentoxifylline InjectionCYHS2400498 CISEN PHARMACEUTICAL CO., LTD.
2024/02/05Generic · Class 3 Potassium Phosphates InjectionCYHS2400497 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/02/05Generic · Class 3 Potassium Phosphates InjectionCYHS2400496 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/02/05Generic · Class 3 Allopurinol TabletsCYHS2400495 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/02/05Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2400494 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2024/02/05Generic · Class 3 Acetylcysteine InjectionCYHS2400493 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2024/02/05Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2400490 Jiangsu Ming Sheng Kang Yuan Pharma Co., Ltd. romanized; Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2024/02/05Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2400489 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.; CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/02/05Generic · Class 3 Ibuprofen InjectionCYHS2400488 Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized
2024/02/05Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2400486 Hubei Kai Na Pharma Co., Ltd. romanized; Hubei Mei Si Chuang Pharma Co., Ltd. romanized
2024/02/05Generic · Class 3 Ibuprofen InjectionCYHS2400485 Shaanxi Tian Yu Pharmaceutical Co., Ltd. romanized
2024/02/05Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2400484 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/02/05Generic · Class 3 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English nameCYHS2400483 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/02/05Generic · Class 3 Gatifloxacin Eye DropsCYHS2400482 Hefei Li Min Pharmaceutical Co., Ltd. romanized
2024/02/05Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2400478 Name not romanized; Le Pu Pharmaceutical Technology Co., Ltd. romanized
2024/02/05Generic · Class 3 Diprophylline InjectionCYHS2400476 Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/02/05Generic · Class 3 Diprophylline InjectionCYHS2400475 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/02/05Generic · Class 3 Revefenacin inhalation solutionCYHL2400035 Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized
2024/02/05New drug · Class 2.2 注射用重组人组织型纤溶酶原激酶衍生物 · No verified English nameCXSS2400016 Hua Run Ang De Bio Pharma Co., Ltd. romanized
2024/02/05New drug · Class 1.4 26价肺炎球菌结合疫苗 · No verified English nameCXSL2400099 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2024/02/05New drug · Class 1 KAL-002 · No verified English nameCXSL2400098 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2024/02/05New drug · Class 1 KAL-002 · No verified English nameCXSL2400097 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2024/02/05New drug · Class 1 KAL-002 · No verified English nameCXSL2400096 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2024/02/05New drug · Class 1 KAL-002 · No verified English nameCXSL2400095 Sichuan Yan Yang Bio Technology Co., Ltd. romanized
2024/02/05New drug · Class 1 LY01620 · No verified English nameCXSL2400094 Nanjing Ji Mai Bio Technology Co., Ltd. romanized
2024/02/05New drug · Class 1 HLX53 · No verified English nameCXSL2400093 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2024/02/05New drug · Class 1 SK-08片 · No verified English nameCXHL2400142 Guangzhou Kang Chen Pharma Co., Ltd. romanized
2024/02/05New drug · Class 1 SK-08片 · No verified English nameCXHL2400141 Guangzhou Kang Chen Pharma Co., Ltd. romanized

101 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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