YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 62 drug applications between 4 October 2021 and 10 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 7 drug names.

2021/10/04 – 2021/10/10

Period
2021/10/04 to 2021/10/10, 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
62
Drugs with new generic filings (by drug name, de-duplicated)
7
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

62filings, 10 of them generic

By application type

Application typeFilings
Supplement33
Generic10
New drug8
Unspecified5
Import5
Import re-registration1

By drug type

Drug typeFilings
Chemical drug41
Therapeutic biologic14
TCM5
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

7 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Parecoxib Sodium for Injection322
2Cyclophosphamide Capsules212
3Salbutamol Sulfate Inhalation Solution112
4Diquafosol Sodium Eye Drops115
5Sildenafil Citrate Tablets1112
6Olprinone Hydrochloride Injection111
7Esmolol Hydrochloride and Sodium Chloride Injection110

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

47 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized310
2Zhejiang Guo Jing Pharma Co., Ltd. romanized310
3Shenzhen Li Jian Pharma Co., Ltd. romanized310
4Merck & Co. Inc220
5Bioshin Limited210
6LG Chem Ltd.210
7Shanghai Hua Yuan Pharma (Ningxia) Sha Sai Pharmaceutical Co., Ltd. romanized212
8Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized210
9Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized210
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized212

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

16 this week

AcceptedDrugApplicants
2021/10/09Import · Class 1 Troriluzole 胶囊 · No verified English nameJXHL2101196 Bioshin Limited; BioShin (Shanghai) Co. Ltd.
2021/10/09Import · Class 1 Troriluzole 胶囊 · No verified English nameJXHL2101195 Bioshin Limited; BioShin (Shanghai) Co. Ltd.
2021/10/09Import · Class 1 注射用 WCK5222 · No verified English nameJXHL2101191 Wockhardt Bio AG; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd.
2021/10/09Generic · Class 3 Olprinone Hydrochloride InjectionCYHS2101826 Wu Hu Yang Yan Pharmaceutical Co., Ltd. romanized
2021/10/09New drug · Class 1.1 九味疏风平喘颗粒 · No verified English nameCXZL2101028 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2021/10/09New drug · Class 1 LBL-019注射液 · No verified English nameCXSL2101348 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2021/10/09New drug · Class 1 TST005注射液 · No verified English nameCXSL2101346 Mai Bo Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/10/09New drug · Class 1 SHR-1314注射液 · No verified English nameCXSL2101345 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/10/08Import · Class 2.2 阿替利珠单抗注射液 · No verified English nameJXSL2101116 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/10/08Import · Class 1 BI-1206 · No verified English nameJXSL2101115 BioInvent International AB; CASI Pharmaceuticals (China) Co. Ltd.
2021/10/08Generic · Class 3 Cyclophosphamide CapsulesCYHS2101811 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/08Generic · Class 3 Cyclophosphamide CapsulesCYHS2101810 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2021/10/08New drug · Class 1 LY01019注射液 · No verified English nameCXSL2101351 Shandong Bo An Bio Technology Co., Ltd. romanized
2021/10/08New drug · Class 1 SIM1811-03注射液 · No verified English nameCXSL2101350 Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized
2021/10/08New drug · Class 1 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSL2101347 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2021/10/08New drug · Class 2.2 醋酸阿比特龙软胶囊 · No verified English nameCXHL2101528 Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized

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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