YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 270 drug applications between 16 August 2022 and 22 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 41 drug names.

2022/08/16 – 2022/08/22

Period
2022/08/16 to 2022/08/22, 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
270
Drugs with new generic filings (by drug name, de-duplicated)
41
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

270filings, 61 of them generic

By application type

Application typeFilings
Supplement128
Generic61
New drug34
Import21
Import re-registration17
Unspecified9

By drug type

Drug typeFilings
Chemical drug211
Therapeutic biologic36
TCM20
Biologic2
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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1泊马度胺胶囊 · No verified English name414
2Montelukast Sodium Chewable Tablets324
3Sodium Bicarbonate Ringer’s Injection321
4Oseltamivir Phosphate Capsules3139
5Sitagliptin Phosphate Tablets312
6Gadopentetic Acid Dimeglumine Salt Injection319
7Acetylcysteine Solution For Inhalation224
8Tadalafil Tablets2123
9Entecavir Tablets210
10Sevelamer Carbonate Powder for oral suspension213

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

167 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized15150
2Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized10100
3Qilu Pharmaceutical Co., Ltd.624
4Guo Yao Group Gong Ye Co., Ltd. romanized550
5Bristol-Myers Squibb Pharma EEIG510
6Li Zhu Group Li Zhu Pharmaceutical Factory romanized510
7Shandong Qidu Pharmaceutical Co., Ltd.424
8Sanofi-aventis groupe410
9Atlantic Laboratories Corporation Ltd.310
10Santen Pharmaceutical Co. Ltd.310

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

72 this week

AcceptedDrugApplicants
2022/08/22Import · Class 1 RO7247669注射液 · No verified English nameJXSL2200139 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd
2022/08/22Import · Class 1 LOU064片 · No verified English nameJXHL2200248 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/22Generic · Class 3 Aripiprazole Oral SolutionCYHS2201311 Shenyang Tian Bang Pharma Co., Ltd. romanized
2022/08/22Generic · Class 3 Pimavanserin Tartrate CapsulesCYHL2200072 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2022/08/22Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2200070 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized
2022/08/22New drug · Class 1 AK129注射液 · No verified English nameCXSL2200395 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2022/08/22New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2200390 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2022/08/22New drug · Class 1 PM8002注射液 · No verified English nameCXSL2200389 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2022/08/22New drug · Class 1 GC101 · No verified English nameCXSL2200388 Shanghai Jing Shan Bio Technology Co., Ltd. romanized
2022/08/22New drug · Class 1 HLX22单抗注射液 · No verified English nameCXSL2200386 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/08/22New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSL2200385 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/08/22New drug · Class 1 JS015注射液 · No verified English nameCXSL2200380 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/08/22New drug · Class 1 TR64片 · No verified English nameCXHL2200606 Anhui Zhong Ke Tuo Ran Drug Ke Xue Research Co., Ltd. romanized
2022/08/22New drug · Class 2.2; 2.4 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200605 Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2022/08/22New drug · Class 2.2; 2.4 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200604 Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2022/08/22New drug · Class 2.2; 2.4 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200602 Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2022/08/22New drug · Class 2.2; 2.4 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200601 Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2022/08/22New drug · Class 2.2 艾普拉唑微丸肠溶片 · No verified English nameCXHL2200600 Li Zhu Group Li Zhu Pharmaceutical Factory romanized
2022/08/19Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2201348 Shandong Qidu Pharmaceutical Co., Ltd.
2022/08/19Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2201347 Shandong Qidu Pharmaceutical Co., Ltd.
2022/08/19Generic · Class 3 Peramivir InjectionCYHS2201341 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2022/08/19Generic · Class 3 Gallium[68Ga ] Dotatate InjectionCYHL2200068 Yuan Zi Gao Ke Co., Ltd. romanized
2022/08/19Generic · Class 3 Kit For The Preparation Of Gallium Ga 68 Dotatate InjectionCYHL2200067 Yuan Zi Gao Ke Co., Ltd. romanized
2022/08/19New drug · Class 3.3 注射用重组人促卵泡激素 · No verified English nameCXSL2200384 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2022/08/19New drug · Class 2.1 人干扰素α1b吸入溶液 · No verified English nameCXSL2200383 Shenzhen Ke Xing Pharma Co., Ltd. romanized
2022/08/19New drug · Class 2.1 人干扰素α1b吸入溶液 · No verified English nameCXSL2200382 Shenzhen Ke Xing Pharma Co., Ltd. romanized
2022/08/19New drug · Class 1 注射用重组人源化抗HER2单抗-AS269偶联物(ARX788) · No verified English nameCXSL2200381 Zhejiang Xin Ma Biopharmaceuticals Co., Ltd. romanized
2022/08/19New drug · Class 1 STC007注射液 · No verified English nameCXHL2200599 Chengdu Nuo He Cheng Tai Bio Technology Co., Ltd. romanized
2022/08/19New drug · Class 1 JAB-2485片 · No verified English nameCXHL2200598 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2022/08/19New drug · Class 1 JAB-2485片 · No verified English nameCXHL2200597 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized

42 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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