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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 144 drug applications between 9 December 2022 and 15 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 27 drug names.

2022/12/09 – 2022/12/15

Period
2022/12/09 to 2022/12/15, 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
144
Drugs with new generic filings (by drug name, de-duplicated)
27
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

144filings, 35 of them generic

By application type

Application typeFilings
Supplement64
Generic35
New drug23
Import re-registration15
Import5
Unspecified2

By drug type

Drug typeFilings
Chemical drug120
Therapeutic biologic18
TCM5
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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Latamoxef Sodium for Injection311
2Diquafosol Sodium Eye Drops215
3Pregabalin Extended release Tablets2113
4Lenalidomide Capsules213
5Flomoxef Sodium for Injection219
6Urapidil Hydrochloride Injection216
7Oseltamivir Phosphate Capsules2139
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

79 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized12100
2Fresenius Kabi AB1120
3Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized10100
4Janssen Research & Development LLC530
5Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized510
6Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized440
7Guo Yuan Guo Yao (Guangdong) Pharmaceutical Group Co., Ltd. romanized330
8Pfizer Inc.310
9Shandong Jing Hui Bio Technology Co., Ltd. romanized313
10Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized310

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

41 this week

AcceptedDrugApplicants
2022/12/14New drug · Class 1 JMKX003002片 · No verified English nameCXHL2200940 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Jiangxi Guo Yao Co., Ltd. romanized
2022/12/14New drug · Class 1 JMKX003002片 · No verified English nameCXHL2200939 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Jiangxi Guo Yao Co., Ltd. romanized
2022/12/14New drug · Class 1 JMKX003002片 · No verified English nameCXHL2200938 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Jiangxi Guo Yao Co., Ltd. romanized
2022/12/14New drug · Class 2.2 氟尿嘧啶植入剂 · No verified English nameCXHL2200937 Hefei Ji An Pharmaceuticals Research Co., Ltd. romanized
2022/12/13Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2202066 Shuang He Pharma (Hainan) Co., Ltd. romanized
2022/12/13New drug · Class 1 赫基仑赛注射液(暂定) · No verified English nameCXSS2200093 He Yuan Bio Technology (Tianjin) Co., Ltd. romanized
2022/12/13New drug · Class 3.3 利妥昔单抗注射液 · No verified English nameCXSS2200092 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2022/12/13New drug · Class 2.2 注射用A型肉毒毒素 · No verified English nameCXSL2200602 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2022/12/13New drug · Class 2.2 注射用A型肉毒毒素 · No verified English nameCXSL2200601 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
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

11 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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