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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 246 drug applications between 19 February 2021 and 25 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 33 drug names.

2021/02/19 – 2021/02/25

Period
2021/02/19 to 2021/02/25, 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
246
Drugs with new generic filings (by drug name, de-duplicated)
33
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

246filings, 44 of them generic

By application type

Application typeFilings
Supplement127
Generic44
New drug43
Import25
Unspecified4
Import re-registration3

By drug type

Drug typeFilings
Chemical drug188
Therapeutic biologic41
Prophylactic biologic10
TCM6
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

33 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules420
2Torsemide Injection321
3Olanzapine Orally Disintegrating Tablets210
4Pregabalin Capsules2112
5Pemetrexed Disodium for Injection214
6Dexmedetomidine Hydrochloride Injection211
7Palonosetron Hydrochloride Injection211
8色甘酸钠颗粒 · No verified English name210
9丙酸氟替卡松吸入粉雾剂 · No verified English name111
10Dantrolene Sodium Capsules110

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

144 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Pfizer Europe MA EEIG730
2CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD630
3Xian Jing Xi Shuang He Pharma Co., Ltd. romanized620
4Eli Lilly and Company610
5Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized532
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized531
7Novo Nordisk A/S520
8Hebei Tian Cheng Pharma Co., Ltd. romanized440
9Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized420
10Fertin Pharma A/S410

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

75 this week

AcceptedDrugApplicants
2021/02/25Import · Class 3.1 双价人乳头瘤病毒吸附疫苗 · No verified English nameJXSS2100018 GlaxoSmithKline Biologicals S.A.; GlaxoSmithKline Biologicals SA
2021/02/25Import · Class 3.1 双价人乳头瘤病毒吸附疫苗 · No verified English nameJXSS2100017 GlaxoSmithKline Biologicals S.A.; GlaxoSmithKline Biologicals SA
2021/02/25Import · Class 1 Mim8 · No verified English nameJXSL2100034 Novo Nordisk A/S
2021/02/25Import · Class 1 Mim8 · No verified English nameJXSL2100033 Novo Nordisk A/S
2021/02/25Import · Class 1 Tirzepatide注射液 · No verified English nameJXHL2100063 Eli Lilly and Company
2021/02/25Import · Class 1 Tirzepatide注射液 · No verified English nameJXHL2100062 Eli Lilly and Company
2021/02/25Import · Class 1 Tirzepatide注射液 · No verified English nameJXHL2100061 Eli Lilly and Company
2021/02/25Import · Class 1 Tirzepatide注射液 · No verified English nameJXHL2100060 Eli Lilly and Company
2021/02/25Import · Class 1 Tirzepatide注射液 · No verified English nameJXHL2100059 Eli Lilly and Company
2021/02/25Import · Class 1 Tirzepatide注射液 · No verified English nameJXHL2100058 Eli Lilly and Company
2021/02/25Generic · Class 3 Dantrolene Sodium CapsulesCYHS2100222 Wuhan Heng Xin Yuan Pharma Co., Ltd. romanized
2021/02/25New drug · Class 1 BJ-001注射液 · No verified English nameCXSL2100071 Bo Ji Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2021/02/25New drug · Class 1 BAT6026注射液 · No verified English nameCXSL2100070 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/02/25New drug · Class 1 注射用SSGJ-612 · No verified English nameCXSL2100069 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/02/25New drug · Class 2.2 盐酸美沙酮泡腾片 · No verified English nameCXHS2100007 Qinghai Pharmaceutical Co., Ltd. romanized
2021/02/25New drug · Class 2.2 盐酸美沙酮泡腾片 · No verified English nameCXHS2100006 Qinghai Pharmaceutical Co., Ltd. romanized
2021/02/25New drug · Class 2.2 盐酸美沙酮泡腾片 · No verified English nameCXHS2100005 Qinghai Pharmaceutical Co., Ltd. romanized
2021/02/25New drug · Class 1 苹果酸Sitravatinib胶囊 · No verified English nameCXHL2100137 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/02/25New drug · Class 1 苹果酸Sitravatinib胶囊 · No verified English nameCXHL2100136 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/02/25New drug · Class 2.4 Tirofiban Hydrochloride And Sodium Chloride InjectionCXHL2100135 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2021/02/24Import · Class 3.1 13价肺炎球菌多糖结合疫苗 · No verified English nameJXSS2100019 Pfizer Europe MA EEIG; Pfizer Ireland Pharmaceuticals
2021/02/24Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2100237 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/02/24Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2100236 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/02/24Generic · Class 3 Entecavir oral solutionCYHS2100235 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized; Bei Ke Nuo Dun (Zhejiang) Pharmaceutical Co., Ltd. romanized
2021/02/24Generic · Class 3 Torsemide InjectionCYHS2100233 Kang Pu Pharma Co., Ltd. romanized
2021/02/24Generic · Class 3 Torsemide InjectionCYHS2100232 Kang Pu Pharma Co., Ltd. romanized
2021/02/24Generic · Class 3 色甘酸钠颗粒 · No verified English nameCYHS2100229 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2021/02/24Generic · Class 3 色甘酸钠颗粒 · No verified English nameCYHS2100228 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2021/02/24Generic · Class 3 Torsemide InjectionCYHS2100227 Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/02/24Generic · Class 3 Furosemide InjectionCYHS2100223 Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized

45 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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