YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 259 drug applications between 25 May 2024 and 31 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 54 drug names.

2024/05/25 – 2024/05/31

Period
2024/05/25 to 2024/05/31, 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
259
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
0

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

259filings, 70 of them generic

By application type

Application typeFilings
Supplement118
Generic70
New drug50
Import11
Import re-registration10

By drug type

Drug typeFilings
Chemical drug172
TCM43
Therapeutic biologic41
Prophylactic biologic2
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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution7334
2阿普米司特片 · No verified English name313
3Minocycline Hydrochloride Capsules2119
4Esmolol Hydrochloride and Sodium Chloride Injection210
5Thioctic Acid Tablets214
6Ioversol Injection219
7Sitagliptin Phosphate Tablets212
8Vitamin K1 Injection216
9Roxadustat Capsules2117
10Azilsartan Medoxomil Potassium Tablets2135

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

156 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
8Fresenius Kabi Austria GmbH410
9Shandong Bo An Bio Technology Co., Ltd. romanized410
10Jilin Sheng Hua Qiao Pharma Group Co., Ltd. romanized330

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

80 this week

AcceptedDrugApplicants
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
2024/05/31New drug · Class 1 ABP2111Na片 · No verified English nameCXHL2400547 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2024/05/31New drug · Class 1 ABP2111Na片 · No verified English nameCXHL2400546 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2024/05/30Generic · Class 3 Thioctic Acid TabletsCYHS2401626 Suzhou Fu Shi Lai Pharmaceuticals Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/05/30Generic · Class 3 Thioctic Acid TabletsCYHS2401625 Suzhou Fu Shi Lai Pharmaceuticals Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2024/05/30Generic · Class 3 Articaine Hydrochloride And Epinephrine InjectionCYHS2401623 Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/05/30New drug · Class 3.1 开心散 · No verified English nameCXZS2400019 Shandong Run Zhong Pharma Co., Ltd. romanized
2024/05/30New drug · Class 1 MG-K10人源化单抗注射液 · No verified English nameCXSL2400354 Shanghai Mai Ji Bio Technology Co., Ltd. romanized
2024/05/30New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2400353 Zhejiang Quan Sheng Bio Technology Co., Ltd. romanized; Hainan Xin Sheng Quan Gan Xi Bao Drug Co., Ltd. romanized
2024/05/30New drug · Class 1 177Lu-LNC1011注射液 · No verified English nameCXHL2400545 Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized
2024/05/29Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2401606 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/05/29Generic · Class 3 Chlorphenamine Maleate InjectionCYHS2401605 Bao Li Hua (Nanjing) Pharmaceutical Co., Ltd. romanized

50 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.