YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 260 drug applications between 6 June 2024 and 12 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 67 drug names.

2024/06/06 – 2024/06/12

Period
2024/06/06 to 2024/06/12, 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
260
Drugs with new generic filings (by drug name, de-duplicated)
67
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

260filings, 88 of them generic

By application type

Application typeFilings
Supplement101
Generic88
New drug44
Import14
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug187
TCM32
Therapeutic biologic32
Prophylactic biologic6
Biologic3

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

67 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Procaterol Hydrochloride Solution for Inhalation432
2Isavuconazonium Sulfate for Injection2215
3Nicardipine Hydrochloride Injection2213
4Nalfurafine Hydrochloride OD Tablets220
5丁酸氯维地平注射用乳剂 · No verified English name210
6Vonoprazan Fumarate Tablets2160
7Empagliflozin Tablets2118
8Lacosamide Injection210
9Amisulpride Injection211
10Methotrexate Injection2111

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

166 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized660
2Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized650
3Shanghai Yi Feng Bio Technology Co., Ltd. romanized610
4Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized550
5AbbVie Inc.520
6Novartis Pharma Schweiz AG520
7Hainan Ai Ke Pharmaceutical Co., Ltd. romanized444
8Qinghai Lu Kang Da Di Pharma Co., Ltd. romanized440
9Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized420
10Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized420

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

93 this week

AcceptedDrugApplicants
2024/06/12Import · Class 1 Ulixacaltamide缓释片 · No verified English nameJXHL2400136 Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd
2024/06/12Import · Class 1 Ulixacaltamide缓释片 · No verified English nameJXHL2400135 Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd
2024/06/12Import · Class 1 Ulixacaltamide缓释片 · No verified English nameJXHL2400134 Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd
2024/06/12Generic · Class 3 Dexrazoxane for InjectionCYHS2401772 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2024/06/12Generic · Class 3 Ferrous Succinate TabletsCYHS2401771 Anhui Jia He Pharma Co., Ltd. romanized
2024/06/12Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2401769 Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized
2024/06/12Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2401763 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/06/12Generic · Class 3 丁酸氯维地平注射用乳剂 · No verified English nameCYHS2401756 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2024/06/12Generic · Class 3 丁酸氯维地平注射用乳剂 · No verified English nameCYHS2401755 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2024/06/12Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2401753 Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Fu Rui Xi Pharma Co., Ltd. romanized
2024/06/12Generic · Class 3 Digoxin InjectionCYHS2401746 Hainan Wei Jian Pharma Co., Ltd. romanized; Shanghai Xin Yi Jin Zhu Pharma Co., Ltd. romanized
2024/06/12Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2401745 Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized
2024/06/12Generic · Class 3 Amisulpride InjectionCYHL2400109 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized
2024/06/12Generic · Class 3 Amisulpride InjectionCYHL2400108 Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized
2024/06/12Generic · Class 3 Meloxicam injectionCYHL2400107 Zhejiang Sheng Zhao Drug Technology Co., Ltd. romanized
2024/06/12Generic · Class 3 Relugolix TabletsCYHL2400106 Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized
2024/06/12Generic · Class 3 Ferrous Sulfate Extended-release TabletsCYHL2400105 Jilin Tian Heng Pharma Co., Ltd. romanized
2024/06/12New drug · Class 1.1 参苓溃康颗粒 · No verified English nameCXZL2400032 Beijing Ying Ke Rui Innovation Pharmaceuticals Co., Ltd. romanized
2024/06/12New drug · Class 1 注射用KJ103 · No verified English nameCXSL2400378 Shanghai Bao Ji Pharma Co., Ltd. romanized
2024/06/12New drug · Class 1 注射用BB-1701 · No verified English nameCXSL2400377 Bai Li Si Kang Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2024/06/12New drug · Class 1 SYS6010 · No verified English nameCXSL2400376 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/06/12New drug · Class 1 BC011抗体注射液 · No verified English nameCXSL2400375 Bao Chuan Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/06/12New drug · Class 1 注射用RC88 · No verified English nameCXSL2400374 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/06/12New drug · Class 1 注射用莱古比星 · No verified English nameCXHL2400594 Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized
2024/06/12New drug · Class 1 注射用莱古比星 · No verified English nameCXHL2400593 Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized
2024/06/12New drug · Class 1 ATG-037 · No verified English nameCXHL2400592 Shanghai De Qi Pharmaceuticals Technology Co., Ltd. romanized
2024/06/12New drug · Class 1 BGB-43395片 · No verified English nameCXHL2400591 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/06/12New drug · Class 1 BGB-43395片 · No verified English nameCXHL2400590 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/06/12New drug · Class 1 BGB-43395片 · No verified English nameCXHL2400589 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2024/06/12New drug · Class 2.4 注射用西罗莫司(白蛋白结合型) · No verified English nameCXHL2400588 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized

63 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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