YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 305 drug applications between 17 August 2022 and 23 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 39 drug names.

2022/08/17 – 2022/08/23

Period
2022/08/17 to 2022/08/23, 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
305
Drugs with new generic filings (by drug name, de-duplicated)
39
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

305filings, 60 of them generic

By application type

Application typeFilings
Supplement159
Generic60
New drug46
Import20
Import re-registration13
Unspecified7

By drug type

Drug typeFilings
Chemical drug227
Therapeutic biologic44
TCM30
Biologic2
Prophylactic 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

39 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Bicarbonate Ringer’s Injection431
2Magnesium Sulfate Injection317
3Oseltamivir Phosphate Capsules3139
4Sitagliptin Phosphate Tablets312
5Gadopentetic Acid Dimeglumine Salt Injection319
6Peramivir Injection227
7Esmolol Hydrochloride Injection223
8Hydrotalcite Suspension229
9Tadalafil Tablets2123
10Bromhexine Hydrochloride Solution For Inhalation211

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

168 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Hui Hai Pharmaceuticals Technology Research Institute Co., Ltd. romanized15150
2Guo Yao Group Gong Ye Co., Ltd. romanized11110
3Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized10100
4Hubei Mei Lin Pharma Co., Ltd. romanized1060
5Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized990
6Henan Run Hong Ben Cao Pharmaceutical Co., Ltd. romanized770
7Li Zhu Group Li Zhu Pharmaceutical Factory romanized610
8Shijiazhuang No.4 Pharmaceutical Co., Ltd.535
9Novartis Pharma AG520
10Bristol-Myers Squibb Pharma EEIG510

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

87 this week

AcceptedDrugApplicants
2022/08/23Import · Class 1 Peresolimab注射液 · No verified English nameJXSL2200141 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/08/23Import · Class 1.1 MVA-BN-RSV疫苗 · No verified English nameJXSL2200138 Bavarian Nordic A/S; Nuance Pharma (Shanghai) Co. Ltd.
2022/08/23Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2200134 Merck Sharp &. Dohme Corp.; MSD R&D (China) Co. Ltd.
2022/08/23Import · Class 2.4 ABL001胶囊装微片 · No verified English nameJXHL2200252 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/23Import · Class 2.4 ABL001胶囊装微片 · No verified English nameJXHL2200251 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/23Import · Class 2.4 ABL001胶囊装微片 · No verified English nameJXHL2200250 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/23Import · Class 2.4 ABL001胶囊装微片 · No verified English nameJXHL2200249 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2022/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2201367 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2201366 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2201365 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/08/23Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201364 Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized
2022/08/23Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2201363 Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized
2022/08/23Generic · Class 3 Hydrotalcite SuspensionCYHS2201360 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/08/23Generic · Class 3 Peramivir InjectionCYHS2201359 Wen Zhou Hai He Pharma Co., Ltd. romanized; Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized
2022/08/23Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2201356 Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
2022/08/23Generic · Class 3 Potassium Chloride InjectionCYHS2201317 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Tianjin Jin Yao Pharma Co., Ltd. romanized
2022/08/23Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2201316 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shanxi Pu De Pharma Co., Ltd. romanized
2022/08/23Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2201309 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/08/23Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2200071 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized
2022/08/23Generic · Class 3 Lidocaine and Tetracaine CreamCYHL2200069 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2022/08/23New drug · Class 2.2 替雷利珠单抗注射液 · No verified English nameCXSS2200075 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized
2022/08/23New drug · Class 3.4 人生长激素注射液 · No verified English nameCXSS2200074 Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized
2022/08/23New drug · Class 1 IBI110 · No verified English nameCXSL2200397 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/08/23New drug · Class 1 HK010注射液 · No verified English nameCXSL2200396 Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized; Hefei Han Ke Mai Bo Bio Technology Co., Ltd. romanized
2022/08/23New drug · Class 1 SHR-7367注射液 · No verified English nameCXSL2200394 Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized
2022/08/23New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200393 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2022/08/23New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200392 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2022/08/23New drug · Class 1 LM-102注射液 · No verified English nameCXSL2200391 Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized
2022/08/23New drug · Class 1 IMM2520注射液 · No verified English nameCXSL2200387 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/08/23New drug · Class 1 ATG-037胶囊 · No verified English nameCXHL2200612 De Li (Zhejiang) Pharmaceuticals Co., Ltd. romanized

57 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.