YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 304 drug applications between 5 January 2022 and 11 January 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 40 drug names.

2022/01/05 – 2022/01/11

Period
2022/01/05 to 2022/01/11, 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
304
Drugs with new generic filings (by drug name, de-duplicated)
40
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

304filings, 48 of them generic

By application type

Application typeFilings
Supplement163
Generic48
New drug43
Import33
Unspecified9
Import re-registration8

By drug type

Drug typeFilings
Chemical drug207
Therapeutic biologic51
TCM40
Biologic4
Prophylactic biologic2

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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2Latamoxef Sodium for Injection311
3地氯雷他定口服溶液 · No verified English name2226
4Octreotide Acetate Microspheres for Injection210
5Nalbuphine Hydrochloride Injection2111
6Febuxostat Tablets2112
7Lactulose Oral Solution1134
8Voriconazole for Oral Suspension111
9Carbazochrome Sodium Sulfonate Injection111
10Irbesartan Tablets114

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

177 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Bei Pharmaceutical Group Xian Tai Pharma Co., Ltd. romanized1740
2Haerbin Hong Dou Shan Biopharmaceutical Co., Ltd. romanized870
3Jiangxi Jiu Hua Pharma Co., Ltd. romanized730
4Henan Fu Ren Tang Pharmaceutical Co., Ltd. romanized660
5Hubei Rui Ze Pharma Co., Ltd. romanized660
6NewAmsterdam Pharma B.V.420
7Pfizer Europe MA EEIG420
8YaoPharma Co., Ltd.424
9Fresenius Kabi AB410
10Nian Yan Pharma (Zhuhai) Co., Ltd. romanized410

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

84 this week

AcceptedDrugApplicants
2022/01/11Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2200043 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/01/11Generic · Class 3 Nalbuphine Hydrochloride InjectionCYHS2200042 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2022/01/11Generic · Class 3 Latamoxef Sodium for InjectionCYHS2200040 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/01/11Generic · Class 3 Latamoxef Sodium for InjectionCYHS2200039 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/01/11Generic · Class 3 Latamoxef Sodium for InjectionCYHS2200038 Hainan Ling Kang Pharmaceutical Co., Ltd. romanized
2022/01/11Generic · Class 3 Levofloxacin InjectionCYHS2200036 Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/01/11Generic · Class 3 Timolol Maleate Eye DropsCYHS2200033 Wuhan Wu Jing Pharmaceuticals Technology Co., Ltd. romanized; Wuhan Wu Jing Pharma Co., Ltd. romanized
2022/01/11Generic · Class 3 Gadobenate Dimeglumine InjectionCYHS2200032 Hainan Brilliant Pharmaceutical Co., Ltd.
2022/01/11Generic · Class 3 Nimodipine Oral SolutionCYHS2200017 Zhejiang Guo Jing Pharma Co., Ltd. romanized
2022/01/11Generic · Class 3 Fludrocortisone Acetate TabletsCYHS2102312 Jiangsu Fu Xin Yu Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wan He Pharmaceutical Co., Ltd. romanized
2022/01/11Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHL2200002 Zhang Feng Pharma Co., Ltd. romanized
2022/01/11New drug · Class 3.3 利妥昔单抗注射液 · No verified English nameCXSS2200002 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/01/11New drug · Class 1 泽贝妥单抗注射液 · No verified English nameCXSS2200001 Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized; Hai Zheng Biopharmaceutical Co., Ltd. romanized
2022/01/11New drug · Class 1 AK127注射液 · No verified English nameCXSL2200011 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2022/01/11New drug · Class 1 伏罗尼布片 · No verified English nameCXHS2200003 Bei Da Pharma Co., Ltd. romanized
2022/01/11New drug · Class 2.2 阿立哌唑口溶膜 · No verified English nameCXHS2200002 Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized
2022/01/11New drug · Class 2.2 阿立哌唑口溶膜 · No verified English nameCXHS2200001 Li Pin Pharma (Xiamen) Co., Ltd. romanized; Xiamen Li Zhuo Pharma Co., Ltd. romanized
2022/01/11New drug · Class 1 注射用GNP · No verified English nameCXHL2200012 Guangzhou Lei En Kang Ya Biopharmaceuticals Technology Co., Ltd. romanized
2022/01/11New drug · Class 1 注射用HSK36273 · No verified English nameCXHL2200011 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2022/01/11New drug · Class 1 盐酸安舒法辛缓释片 · No verified English nameCXHL2200010 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2022/01/11New drug · Class 1 盐酸安舒法辛缓释片 · No verified English nameCXHL2200009 Shandong Lv Ye Pharmaceutical Co., Ltd. romanized
2022/01/10Import · Class 2.4 Baricitinib TabletsJXHS2200004 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2022/01/10Import · Class 2.4 Baricitinib TabletsJXHS2200003 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2022/01/10Generic · Class 3 Digoxin InjectionCYHS2200029 Lang Tian Pharma (Hubei) Co., Ltd. romanized
2022/01/10Generic · Class 3 盐酸溴已新注射液 · No verified English nameCYHS2200026 Jilin Si Zhang Pharmaceutical Co., Ltd. romanized
2022/01/10Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2200024 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/01/10Generic · Class 3 Desmopressin Acetate Oral SolutionCYHS2200023 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2022/01/10Generic · Class 3 Obeticholic Acid TabletsCYHL2200001 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.
2022/01/10New drug · Class 1 QX005N注射液 · No verified English nameCXSL2200010 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2022/01/10New drug · Class 1 SSGJ-617注射液 · No verified English nameCXSL2200008 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized

54 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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