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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 173 drug applications between 6 December 2022 and 12 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 30 drug names.

2022/12/06 – 2022/12/12

Period
2022/12/06 to 2022/12/12, 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
173
Drugs with new generic filings (by drug name, de-duplicated)
30
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

173filings, 38 of them generic

By application type

Application typeFilings
Supplement80
Generic38
New drug27
Import re-registration16
Import9
Unspecified3

By drug type

Drug typeFilings
Chemical drug138
Therapeutic biologic27
TCM8

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

30 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Latamoxef Sodium for Injection311
2Tedizolid Phosphate Tablets221
3Pregabalin Extended release Tablets2113
4Lenalidomide Capsules213
5Flomoxef Sodium for Injection219
6Oseltamivir Phosphate Capsules2139
7Elagolix Sodium Tablets212
8利奈唑胺干混悬剂 · No verified English name111
9Morinidazole and Sodium Chloride Injection119
10Indapamide Tablets110

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

95 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized1280
2Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized1120
3Janssen Research & Development LLC840
4Fresenius Kabi AB610
5Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized510
6Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized430
7Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized410
8Atlantic Laboratories Corporation Ltd.310
9Pfizer Inc.310
10Santen Pharmaceutical Co. Ltd.310

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

50 this week

AcceptedDrugApplicants
2022/12/10Import · Class 3.1 帕博利珠单抗注射液 · No verified English nameJXSS2200038 Merck Sharp & Dohme LLC; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2022/12/10Generic · Class 3 Adenosine InjectionCYHS2202062 Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2022/12/10Generic · Class 3 Dobutamine Hydrochloride InjectionCYHS2202060 Anhui Mao Kang Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/12/10Generic · Class 3 Latamoxef Sodium for InjectionCYHS2202057 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2022/12/10Generic · Class 3 Latamoxef Sodium for InjectionCYHS2202056 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2022/12/10Generic · Class 3 Latamoxef Sodium for InjectionCYHS2202055 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2022/12/10Generic · Class 3 Aminocaproic Acid InjectionCYHS2202054 Anhui Hai Si Mei Pharmaceuticals Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2022/12/10Generic · Class 3 利奈唑胺干混悬剂 · No verified English nameCYHS2202052 Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized
2022/12/10Generic · Class 3 Pregabalin Extended release TabletsCYHL2200112 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/12/10Generic · Class 3 Pregabalin Extended release TabletsCYHL2200111 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2022/12/10New drug · Class 1 注射用LBL-033 · No verified English nameCXSL2200600 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2022/12/10New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSL2200599 Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized
2022/12/10New drug · Class 1 BGB-A445注射液 · No verified English nameCXSL2200598 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2022/12/10New drug · Class 1 LBL-007注射液 · No verified English nameCXSL2200597 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2022/12/10New drug · Class 1 EOC202注射液 · No verified English nameCXSL2200596 Tai Zhou Yi Teng Jing Ang Pharma Co., Ltd. romanized
2022/12/10New drug · Class 1 AP301胶囊 · No verified English nameCXHL2200936 Shanghai Li Bang Pharmaceuticals Technology Co., Ltd. romanized; Li Bang Biopharmaceuticals (Jiangsu) Co., Ltd. romanized
2022/12/09Import · Class 1 PF-07284892片 · No verified English nameJXHL2200347 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/12/09Import · Class 1 PF-07284892片 · No verified English nameJXHL2200346 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/12/09Import · Class 1 PF-07284892片 · No verified English nameJXHL2200345 Pfizer Inc.; Pfizer Investment CO. Ltd.
2022/12/09Generic · Class 3 Fluorouracil InjectionCYHS2202050 Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized; Ha Yao Group Bio Gong Cheng Co., Ltd. romanized
2022/12/09Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2202049 Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2022/12/09Generic · Class 3 Gallium[68Ga ] Dotatate InjectionCYHL2200110 Yuan Zi Gao Ke Co., Ltd. romanized
2022/12/09Generic · Class 3 Kit For The Preparation Of Gallium Ga 68 Dotatate InjectionCYHL2200109 Yuan Zi Gao Ke Co., Ltd. romanized
2022/12/09New drug · Class 1 重组人CD80突变体-Fc融合蛋白注射液 · No verified English nameCXSL2200595 Xuan Zhu Bio Technology Co., Ltd. romanized; Beijing Xuan Zhu Kang Ming Bio Technology Co., Ltd. romanized
2022/12/09New drug · Class 1 SG1906注射液 · No verified English nameCXSL2200594 Zhong Sheng Shang Jian Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200934 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200933 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200932 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200931 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized
2022/12/09New drug · Class 1 DBM-1152A吸入溶液 · No verified English nameCXHL2200930 Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized

20 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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