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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 225 drug applications between 6 February 2022 and 12 February 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 31 drug names.

2022/02/06 – 2022/02/12

Period
2022/02/06 to 2022/02/12, 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
225
Drugs with new generic filings (by drug name, de-duplicated)
31
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

225filings, 51 of them generic

By application type

Application typeFilings
Supplement109
Generic51
New drug43
Import13
Import re-registration7
Unspecified2

By drug type

Drug typeFilings
Chemical drug166
Therapeutic biologic39
TCM16
Prophylactic biologic4

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

31 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets515
2Rosuvastatin Calcium Tablets4218
3Sodium Hyaluronate Eye Drops3330
4Rivaroxaban Tablets323
5氧 · No verified English name2215
6Etoricoxib Tablets218
7Obeticholic Acid Tablets210
8Levofloxacin and Sodium Chloride Injection2114
9Empagliflozin Tablets2118
10Sildenafil Citrate Tablets2112

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

135 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB720
2Anhui Yu Heng Bio Technology Co., Ltd. romanized630
3Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized630
4Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized610
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
6Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized515
7CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD431
8Shanghai Mei Yue Bio Technology Development Co., Ltd. romanized420
9Hunan Ke Lun Pharmaceutical Co., Ltd. romanized420
10Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized330

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

67 this week

AcceptedDrugApplicants
2022/02/11Import · Class 2.4 NBTXR3 · No verified English nameJXHL2200037 Nanobiotix S.A.; Shanghai LianBio Development Co. Ltd.
2022/02/11Generic · Class 3 Oxytocin InjectionCYHS2200300 Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2022/02/11Generic · Class 3 Oxytocin InjectionCYHS2200299 Xian Nuo Da Xin Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2022/02/11Generic · Class 3 Biapenem For InjectionCYHS2200297 Shenzhen Hua Yao Nan Fang Pharmaceutical Co., Ltd. romanized
2022/02/11Generic · Class 3 lorazepam injectionCYHL2200016 Jiangsu En Hua Pharma Co., Ltd. romanized
2022/02/11New drug · Class 1 重组全人抗LAG-3单克隆抗体注射液 · No verified English nameCXSL2200089 Guangzhou Yu Heng Bio Technology Co., Ltd. romanized
2022/02/11New drug · Class 1 IBI322 · No verified English nameCXSL2200088 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2200087 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2200086 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2200085 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/02/11New drug · Class 1 注射用RC98 · No verified English nameCXSL2200084 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2022/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2200083 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2200082 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/02/11New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2200081 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/02/11New drug · Class 3.3 贝伐珠单抗注射液 · No verified English nameCXSL2200079 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/02/11New drug · Class 1 斯鲁利单抗注射液 · No verified English nameCXSL2200078 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/02/11New drug · Class 1 注射用莱古杉醇 · No verified English nameCXHL2200087 Shanghai Qin He Li Biopharmaceuticals Technology Co., Ltd. romanized
2022/02/11New drug · Class 1 MY008211A片 · No verified English nameCXHL2200085 Shanghai Mei Yue Bio Technology Development Co., Ltd. romanized
2022/02/11New drug · Class 1 MY008211A片 · No verified English nameCXHL2200084 Shanghai Mei Yue Bio Technology Development Co., Ltd. romanized
2022/02/11New drug · Class 1 RGT-419B胶囊 · No verified English nameCXHL2200077 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2022/02/11New drug · Class 1 RGT-419B胶囊 · No verified English nameCXHL2200076 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2022/02/10Generic · Class 3 Cycloserine CapsulesCYHS2200291 Shenyang Hong Qi Pharmaceutical Co., Ltd. romanized
2022/02/10Generic · Class 3 Nicorandil for InjectionCYHS2200287 Chongqing De Cheng Yong Dao Pharmaceuticals Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd.
2022/02/10Generic · Class 3 立他司特滴眼液 · No verified English nameCYHL2200015 Qilu Pharmaceutical Co., Ltd.
2022/02/10Generic · Class 3 Obeticholic Acid TabletsCYHL2200014 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2022/02/10Generic · Class 3 Obeticholic Acid TabletsCYHL2200013 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2022/02/10New drug · Class 1 重组抗EGFR人源化单克隆抗体注射液 · No verified English nameCXSL2200077 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/02/10New drug · Class 1 注射用BAT8009 · No verified English nameCXSL2200074 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2022/02/10New drug · Class 2.2 BCM323口服溶液 · No verified English nameCXHL2200086 Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized
2022/02/10New drug · Class 2.2 洛索洛芬钠控释片 · No verified English nameCXHL2200078 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized

37 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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