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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 321 drug applications between 5 September 2024 and 11 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 80 drug names.

2024/09/05 – 2024/09/11

Period
2024/09/05 to 2024/09/11, 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
321
Drugs with new generic filings (by drug name, de-duplicated)
80
Accepted this week, now under review
5

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

321filings, 122 of them generic

By application type

Application typeFilings
Supplement127
Generic122
New drug52
Import9
Import re-registration8
Unspecified3

By drug type

Drug typeFilings
Chemical drug230
TCM53
Therapeutic biologic35
Prophylactic biologic2
Biologic1

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
1Nicardipine Hydrochloride Injection5313
2Levocetirizine dihydrochloride Oral Solution525
3Sodium Hyaluronate Eye Drops3230
4Trazodone Hydrochloride Tablets325
5Sodium Bicarbonate Injection3210
6Brexpiprazole Orally Disintegrating Tablets3110
7Erythromycin Lactobionate for Injection3113
8注射用头孢唑肟钠 · No verified English name314
9Acetylcysteine Solution For Inhalation224
10Bilastine Tablets227

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

215 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

110 this week

AcceptedDrugApplicants
2024/09/11Import · Class 2.2 艾加莫德α注射液(皮下注射) · No verified English nameJXSL2400164 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2024/09/11Generic · Class 3 MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2403033 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2024/09/11Generic · Class 3 Metaraminol Tartrate InjectionCYHS2403029 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/09/11Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2403026 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized
2024/09/11Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2403025 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/09/11Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2403024 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/09/11Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2403023 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2024/09/11Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2403020 Beijing SL Pharmaceutical Co., Ltd.
2024/09/11Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2403019 Beijing SL Pharmaceutical Co., Ltd.
2024/09/11Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403018 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2024/09/11Generic · Class 3 Vitamin K1 InjectionCYHS2403017 Qilu Pharmaceutical (Hainan) Co., Ltd
2024/09/11Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403016 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Ningbo Shuang Cheng Pharma Co., Ltd. romanized
2024/09/11Generic · Class 3 Potassium Chloride GranulesCYHS2403013 Shenyang Tian Bang Pharma Co., Ltd. romanized
2024/09/11Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2403009 Beijing Foyou Pharma CO.,LTD
2024/09/11Generic · Class 3 Sodium Bicarbonate InjectionCYHS2403007 Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/09/11Generic · Class 3 Bumetanide InjectionCYHS2403001 Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2024/09/11Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2403000 Nan Yang Pu Kang Pharma Co., Ltd. romanized
2024/09/11Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402998 Zhong Run Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/09/11Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2402997 Zhong Run Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2024/09/11Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2402996 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2024/09/11Generic · Class 3 Sodium Bicarbonate InjectionCYHS2402995 Shaanxi Li Cai Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/09/11Generic · Class 3 Sodium Bicarbonate InjectionCYHS2402994 Shaanxi Li Cai Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/09/11Generic · Class 3 Brivaracetam TabletsCYHL2400184 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2024/09/11Generic · Class 3 Brivaracetam TabletsCYHL2400183 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2024/09/11New drug · Class 1.1 金蚕颗粒 · No verified English nameCXZL2400051 Sichuan Sheng Zhong Pharmaceuticals Ke College romanized
2024/09/11New drug · Class 1 注射用DB-1419 · No verified English nameCXSL2400605 Ying En Bio Technology (Shanghai) Co., Ltd. romanized
2024/09/11New drug · Class 1 靶向CD19和CD22 的嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2400604 Shanghai Pharmaceuticals Group Bio Zhi Liao Technology Co., Ltd. romanized
2024/09/11New drug · Class 1 注射用MCLA-129 · No verified English nameCXSL2400603 Bei Da Pharma Co., Ltd. romanized
2024/09/11New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2400091 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2024/09/11New drug · Class 2.2 布瑞哌唑口溶膜 · No verified English nameCXHS2400090 Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized

80 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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