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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 276 drug applications between 26 May 2024 and 1 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 60 drug names.

2024/05/26 – 2024/06/01

Period
2024/05/26 to 2024/06/01, 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
276
Drugs with new generic filings (by drug name, de-duplicated)
60
Accepted this week, now under review
1

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

276filings, 79 of them generic

By application type

Application typeFilings
Supplement126
Generic79
New drug47
Import17
Import re-registration7

By drug type

Drug typeFilings
Chemical drug194
Therapeutic biologic40
TCM38
Prophylactic biologic3
In vitro diagnostic reagent1

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

60 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution7334
2二甲硅油乳剂 · No verified English name3114
3阿普米司特片 · No verified English name313
4Bumetanide Injection2113
5Minocycline Hydrochloride Capsules2119
6Esmolol Hydrochloride and Sodium Chloride Injection210
7Thioctic Acid Tablets214
8Ioversol Injection219
9Sitagliptin Phosphate Tablets212
10Vitamin K1 Injection216

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

171 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Hua Feng Pharmaceutical Co., Ltd. romanized990
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized840
3CHEPLAPHARM Registration GmbH720
4Eli Lilly and Company610
5Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized610
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
7Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized510
8Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized444
9Fresenius Kabi Austria GmbH410
10Shandong Bo An Bio Technology Co., Ltd. romanized410

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

83 this week

AcceptedDrugApplicants
2024/06/01Import · Class 3.1 呼吸道合胞病毒疫苗 · No verified English nameJXSL2400107 Pfizer Inc.; Pfizer Investment CO Ltd.
2024/06/01Import · Class 2.2; 2.4 克拉屈滨胶囊 · No verified English nameJXHL2400125 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2024/06/01Import · Class 2.2; 2.4 克拉屈滨胶囊 · No verified English nameJXHL2400124 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2024/06/01Generic · Class 3 Epalrestat TabletsCYHS2401651 Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized
2024/06/01Generic · Class 3 Potassium Chloride GranulesCYHS2401648 Shandong Pu Rui Man Pharma Co., Ltd. romanized
2024/06/01Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2401646 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized
2024/06/01Generic · Class 3 Bumetanide InjectionCYHS2401641 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/06/01Generic · Class 3 Bumetanide InjectionCYHS2401640 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2024/06/01New drug · Class 1 CS060380片 · No verified English nameCXHL2400553 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/06/01New drug · Class 1 CS060380片 · No verified English nameCXHL2400552 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/06/01New drug · Class 1 CS060380片 · No verified English nameCXHL2400551 Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2024/05/31Import · Class 2.2 Dostarlimab注射液 · No verified English nameJXSL2400106 GlaxoSmithKline Research & Development Limited; GlaxoSmithKline (China) Investment Co. Ltd.
2024/05/31Import · Class 1 VAY736注射液 · No verified English nameJXSL2400105 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/05/31Generic · Class 3 Amisulpride Oral SolutionCYHS2401638 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2024/05/31Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2401634 Hebei Qian Kang Pharmaceuticals Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2024/05/31Generic · Class 3 Isoniazid InjectionCYHS2401633 Ta He Shi Hui Chuang Pharmaceuticals Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2024/05/31Generic · Class 3 Vitamin K1 InjectionCYHS2401632 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2024/05/31Generic · Class 3 Vitamin K1 InjectionCYHS2401631 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2024/05/31New drug · Class 1 夫那奇珠单抗注射液 · No verified English nameCXSL2400363 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/05/31New drug · Class 1 夫那奇珠单抗注射液 · No verified English nameCXSL2400362 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/05/31New drug · Class 1 夫那奇珠单抗注射液 · No verified English nameCXSL2400361 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2024/05/31New drug · Class 1 注射用LNF2007双特异性抗体 · No verified English nameCXSL2400360 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/05/31New drug · Class 1 SHR-2106注射液 · No verified English nameCXSL2400359 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/05/31New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2400358 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/05/31New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2400357 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/05/31New drug · Class 1 HS-20117注射液 · No verified English nameCXSL2400356 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/05/31New drug · Class 1 XMVA09注射液 · No verified English nameCXSL2400355 Hefei Xing Mou Bio Technology Co., Ltd. romanized
2024/05/31New drug · Class 1 BGB-45035片 · No verified English nameCXHL2400550 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/05/31New drug · Class 2.2 BCM878口崩片 · No verified English nameCXHL2400549 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2024/05/31New drug · Class 1 BGB-45035片 · No verified English nameCXHL2400548 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized

53 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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