YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 334 drug applications between 2 December 2023 and 8 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 53 drug names.

2023/12/02 – 2023/12/08

Period
2023/12/02 to 2023/12/08, 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
334
Drugs with new generic filings (by drug name, de-duplicated)
53
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

334filings, 72 of them generic

By application type

Application typeFilings
Supplement166
Generic72
New drug47
Import32
Unspecified10
Import re-registration7

By drug type

Drug typeFilings
Chemical drug225
TCM53
Therapeutic biologic48
Biologic7
Prophylactic 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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1盐酸左沙丁胺醇雾化吸入溶液 · No verified English name312
2阿普米司特片 · No verified English name313
3Diprophylline Injection227
4Morinidazole and Sodium Chloride Injection229
5Roxatidine Acetate Hydrochloride For Injection225
6甘油磷酸钠注射液 · No verified English name227
7Agomelatine Tablets228
8Folic acid injection211
9Bisoprolol Fumarate Tablets216
10Lacosamide Tablets210

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

192 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Lan Yun Zhi He Bio Technology Co., Ltd. romanized20170
2Shanxi Zhen Dong Pharmaceutical Co., Ltd. romanized10100
3medac Gesellschaft für klinische Spezialpr?parate mbH810
4Novo Nordisk A/S720
5Hainan Ying Da Run Ze Pharma Co., Ltd. romanized660
6Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized545
7AstraZeneca AB520
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
9Karuna Therapeutics Inc.510
10Janssen Research & Development LLC420

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

92 this week

AcceptedDrugApplicants
2023/12/08Import · Class 2.2 埃万妥单抗注射液 · No verified English nameJXSS2300088 Janssen-Cilag International NV; Cilag AG; Johnson & Johnson Pharmaceutical Ltd.
2023/12/08Import · Class 1 RAS突变的新生抗原多肽肿瘤疫苗 · No verified English nameJXSL2300218 Targovax Solutions AS; IOVAXIS THERAPEUTICS
2023/12/08Import · Class 1 Camonsertib胶囊 · No verified English nameJXHL2300307 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2023/12/08Import · Class 1 KarXT胶囊 · No verified English nameJXHL2300306 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2023/12/08Import · Class 1 KarXT胶囊 · No verified English nameJXHL2300305 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2023/12/08Import · Class 1 KarXT胶囊 · No verified English nameJXHL2300304 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2023/12/08Import · Class 1 KarXT胶囊 · No verified English nameJXHL2300303 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2023/12/08Import · Class 1 KarXT胶囊 · No verified English nameJXHL2300302 Karuna Therapeutics Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd
2023/12/08Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2303400 Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized
2023/12/08Generic · Class 3 Minoxidil LinimentCYHS2303393 Guangzhou Hu Rui Pharmaceuticals Technology Development Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/12/08Generic · Class 3 Minoxidil LinimentCYHS2303392 Guangzhou Hu Rui Pharmaceuticals Technology Development Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized
2023/12/08Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303390 Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized
2023/12/08New drug · Class 1 QX007N注射液 · No verified English nameCXSL2300850 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2023/12/08New drug · Class 1 注射用HS-20089 · No verified English nameCXSL2300849 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2023/12/08New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2300848 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2023/12/08New drug · Class 1 注射用PRO1107 · No verified English nameCXSL2300847 Pu Fang Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/12/08New drug · Class 1 PT886 · No verified English nameCXSL2300846 Fan En Shi Pharmaceutical (Beijing) Co., Ltd. romanized
2023/12/08New drug · Class 1 JMKX003561颗粒 · No verified English nameCXHL2301357 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/12/08New drug · Class 1 JMKX003561颗粒 · No verified English nameCXHL2301356 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/12/08New drug · Class 1 TL938胶囊 · No verified English nameCXHL2301355 Suzhou Tao Lve Bio Technology Co., Ltd. romanized
2023/12/08New drug · Class 2.2 他达拉非口服冻干片 · No verified English nameCXHL2301354 Beijing Dong Shan Pharmaceuticals Technology Co., Ltd. romanized
2023/12/08New drug · Class 2.2 他达拉非口服冻干片 · No verified English nameCXHL2301353 Beijing Dong Shan Pharmaceuticals Technology Co., Ltd. romanized
2023/12/07Import · Class 3.1 莫妥珠单抗注射液 · No verified English nameJXSS2300087 Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd.
2023/12/07Import · Class 3.1 莫妥珠单抗注射液 · No verified English nameJXSS2300086 Roche Pharma (Schweiz) AG; Genentech Inc.; Roche (China) Holding Ltd.
2023/12/07Generic · Class 3 Foscarnet Sodium InjectionCYHS2303384 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/07Generic · Class 3 Diprophylline InjectionCYHS2303383 Ze Tian (Shandong) Pharma Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
2023/12/07Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303382 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2023/12/07Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2303381 Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized
2023/12/07Generic · Class 3 Diprophylline InjectionCYHS2303378 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/07Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2303377 Hubei Jin Yao Pharma Co., Ltd. romanized

62 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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