YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 278 drug applications between 4 January 2021 and 10 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 28 drug names.

2021/01/04 – 2021/01/10

Period
2021/01/04 to 2021/01/10, 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
278
Drugs with new generic filings (by drug name, de-duplicated)
28
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

278filings, 33 of them generic

By application type

Application typeFilings
Supplement154
New drug49
Generic33
Import31
Unspecified7
Import re-registration4

By drug type

Drug typeFilings
Chemical drug181
Therapeutic biologic69
TCM22
Prophylactic biologic6

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

28 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Pramipexole Dihydrochloride Prolonged-release Tablets310
2Ornidazole Injection210
3Empagliflozin Tablets2118
4Pemetrexed Disodium for Injection214
5Tadalafil Tablets1123
6Rivaroxaban Tablets113
7Risperidone Oral Solution116
8Ambroxol Hydrochloride Solution For Inhalation1110
9Diquafosol Sodium Eye Drops115
10Tenofovir alafenamide Fumarate 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

172 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1BIOTON S.A.730
2Hua Lan Bio Gong Cheng Co., Ltd. romanized610
3Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized610
4Qilu Pharmaceutical Co., Ltd.553
5CSPC OUYI PHARMACEUTICAL CO., LTD.534
6Boehringer Ingelheim International GmbH510
7AstraZeneca AB420
8BAXTER S.A.S420
9Les Laboratoires Servier420
10Fresenius Kabi Austria GmbH410

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

76 this week

AcceptedDrugApplicants
2021/01/09Import · Class 1 Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2100005 Bristol-Myers Squibb Company
2021/01/09Import · Class 2.4 阿贝西利片 · No verified English nameJXHL2100011 Eli Lilly and Company
2021/01/09Import · Class 2.4 Macitentan TabletsJXHL2100010 Actelion Pharmaceuticals Ltd
2021/01/09Import · Class 2.4 Macitentan TabletsJXHL2100009 Actelion Pharmaceuticals Ltd
2021/01/09Import · Class 1 PF-06882961片 · No verified English nameJXHL2100008 Pfizer Inc.
2021/01/09Import · Class 1 PF-06882961片 · No verified English nameJXHL2100007 Pfizer Inc.
2021/01/09Import · Class 1 PF-06882961片 · No verified English nameJXHL2100006 Pfizer Inc.
2021/01/09Generic · Class 3 阿瑞匹坦注射液 · No verified English nameCYHS2100023 Qilu Pharmaceutical Co., Ltd.
2021/01/09New drug · Class 3.2 注射用重组人生长激素 · No verified English nameCXSS2100006 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2021/01/09New drug · Class 3.2 注射用重组人生长激素 · No verified English nameCXSS2100005 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2021/01/09New drug · Class 3.2 注射用重组人生长激素 · No verified English nameCXSS2100004 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2021/01/09New drug · Class 3.2 注射用重组人生长激素 · No verified English nameCXSS2100003 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2021/01/09New drug · Class 3.2 注射用重组人生长激素 · No verified English nameCXSS2100002 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2021/01/09New drug · Class 3.2 注射用重组人生长激素 · No verified English nameCXSS2100001 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized
2021/01/09New drug · Class 1 注射用QLS31901 · No verified English nameCXSL2100012 Qilu Pharmaceutical Co., Ltd.
2021/01/09New drug · Class 1 MCLA-129注射液 · No verified English nameCXSL2100011 Bei Da Pharma Co., Ltd. romanized
2021/01/09New drug · Class 1 SMR7694注射液 · No verified English nameCXSL2100010 Wei Ming Biopharmaceuticals Co., Ltd. romanized
2021/01/09New drug · Class 1 重组人源化抗IL-17A单克隆抗体注射液 · No verified English nameCXSL2100009 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/01/09New drug · Class 2.2 重组人血管内皮抑制素注射液 · No verified English nameCXSL2100008 Shandong Xian Sheng Biopharmaceutical Co., Ltd. romanized
2021/01/09New drug · Class 1 注射用IMM2505 · No verified English nameCXSL2100007 Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized
2021/01/09New drug · Class 2.2 注射用右兰索拉唑 · No verified English nameCXHS2100001 Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized
2021/01/09New drug · Class 2.2; 2.4 HR19042胶囊 · No verified English nameCXHL2100013 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/01/09New drug · Class 1 AB-106胶囊 · No verified English nameCXHL2100012 Bao Yuan Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2021/01/09New drug · Class 2.3 阿利沙坦酯吲达帕胺缓释片 · No verified English nameCXHL2100011 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/01/08Import · Class 3.1 注射用A型肉毒毒素(150KD,不含复合蛋白) · No verified English nameJXSS2100002 Merz Pharmaceuticals GmbH; Merz Pharma GmbH & Co. KGaA
2021/01/08Import · Class 3.1 注射用A型肉毒毒素(150KD,不含复合蛋白) · No verified English nameJXSS2100001 Merz Pharmaceuticals GmbH; Merz Pharma GmbH & Co. KGaA
2021/01/08Import · Class 1 注射用TAK-755 · No verified English nameJXSL2100004 Baxalta Innovations GmbH
2021/01/08Import · Class 1 注射用TAK-755 · No verified English nameJXSL2100003 Baxalta Innovations GmbH
2021/01/08Import · Class 2.4 ATG-010片 · No verified English nameJXHL2100001 Karyopharm Therapeutics Inc.
2021/01/08Generic · Class 3 Adenosine InjectionCYHS2100016 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.

46 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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