YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 241 drug applications between 11 February 2022 and 17 February 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 35 drug names.

2022/02/11 – 2022/02/17

Period
2022/02/11 to 2022/02/17, 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
241
Drugs with new generic filings (by drug name, de-duplicated)
35
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

241filings, 48 of them generic

By application type

Application typeFilings
Supplement138
Generic48
New drug39
Import12
Unspecified4

By drug type

Drug typeFilings
Chemical drug171
Therapeutic biologic48
TCM21
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

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Hyaluronate Eye Drops3330
2Regorafenib Tablets223
3Cinacalcet Hydrochloride Tablets222
4Nintedanib Esilate Soft Capsules216
5Etoricoxib Tablets218
6利奈唑胺干混悬剂 · No verified English name211
7注射用头孢西丁钠/氯化钠注射液 · No verified English name210
8Rosuvastatin Calcium Tablets2118
9Memantine Hydrochloride Tablets212
10Oxytocin Injection218

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

152 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guangxi Zhuang Zu Zi Zhi Qu Hua Hong Jin Rui Pharma Co., Ltd. romanized1080
2Changchun Jin Sai Pharma Co., Ltd. romanized820
3AstraZeneca UK Limited620
4Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized610
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520
6Sanofi-Aventis Deutschland GmbH440
7Hunan Ke Lun Pharmaceutical Co., Ltd. romanized420
8Alembic Pharmaceuticals Limited410
9UCB Pharma S.A.320
10CSPC OUYI PHARMACEUTICAL CO., LTD.320

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

55 this week

AcceptedDrugApplicants
2022/02/17Import · Class 1 Olvi-Vec注射液 · No verified English nameJXSL2200019 Genelux Corporation; Newsoara Biopharma Co. Ltd.
2022/02/17Import · Class 2.2 注射用Belantamab mafodotin · No verified English nameJXSL2200018 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Co. Limited
2022/02/17Generic · Class 3 注射用头孢西丁钠/氯化钠注射液 · No verified English nameCYHS2200336 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2022/02/17Generic · Class 3 注射用头孢西丁钠/氯化钠注射液 · No verified English nameCYHS2200335 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2022/02/17Generic · Class 3 Calcium Polycarbophil Fine GranulesCYHS2200334 Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized
2022/02/17Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2200329 Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2022/02/17Generic · Class 3 Citicoline Sodium InjectionCYHS2200323 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/02/17New drug · Class 3.3 注射用曲妥珠单抗 · No verified English nameCXSS2200015 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/02/17New drug · Class 1 DB-1202注射液 · No verified English nameCXSL2200095 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/02/17New drug · Class 1 PM8002注射液 · No verified English nameCXSL2200094 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2022/02/17New drug · Class 1 R01散 · No verified English nameCXHL2200099 Beijing An Jian Xi Pharmaceuticals Technology Co., Ltd. romanized
2022/02/17New drug · Class 1 TT-01488片 · No verified English nameCXHL2200092 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2022/02/16New drug · Class 2.3 大株红景天胶囊 · No verified English nameCXZL2200010 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/02/16New drug · Class 1 EVER001胶囊 · No verified English nameCXHL2200098 Yun Ding Xin Yao Pharmaceuticals Technology Co., Ltd. romanized
2022/02/16New drug · Class 1 SR750片 · No verified English nameCXHL2200095 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2022/02/16New drug · Class 1 SR750片 · No verified English nameCXHL2200094 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2022/02/15Generic · Class 3 Ambroxol Hydrochloride Oral SolutionCYHS2200305 Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2022/02/15New drug · Class 2.3 金振口服液 · No verified English nameCXZL2200009 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/02/15New drug · Class 1 人源TH-SC01细胞注射液 · No verified English nameCXSL2200093 Jiangsu Tuo Hong Kang Heng Pharmaceuticals Co., Ltd. romanized
2022/02/15New drug · Class 1 CPD-002注射液 · No verified English nameCXSL2200092 Jiangxi Long Chang Pharma Co., Ltd. romanized
2022/02/15New drug · Class 1 注射用8MW2311 · No verified English nameCXSL2200091 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2022/02/15New drug · Class 1 SYHX2005 · No verified English nameCXHL2200097 CSPC OUYI PHARMACEUTICAL CO., LTD.
2022/02/15New drug · Class 1 SYHX2005 · No verified English nameCXHL2200096 CSPC OUYI PHARMACEUTICAL CO., LTD.
2022/02/15New drug · Class 1 XTR006注射液 · No verified English nameCXHL2200090 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2022/02/15New drug · Class 1 BEBT-305片 · No verified English nameCXHL2200089 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/02/15New drug · Class 1 BEBT-305片 · No verified English nameCXHL2200088 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/02/14Generic · Class 3 利奈唑胺干混悬剂 · No verified English nameCYHS2200309 Zhejiang Pu Li Pharma Co., Ltd. romanized
2022/02/14Generic · Class 3 利奈唑胺干混悬剂 · No verified English nameCYHS2200308 Zhejiang Pu Li Pharma Co., Ltd. romanized
2022/02/14Generic · Class 3 Pregabalin Extended release TabletsCYHL2200017 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2022/02/14New drug · Class 1 异体内皮祖细胞(EPCs)注射液 · No verified English nameCXSL2200090 Cheng Nuo Zai Sheng Yi Xue Technology (Zhuhai Heng Qin Xin Qu) Co., Ltd. romanized

25 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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