YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 273 drug applications between 1 July 2022 and 7 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 42, covering 28 drug names.

2022/07/01 – 2022/07/07

Period
2022/07/01 to 2022/07/07, 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
273
Drugs with new generic filings (by drug name, de-duplicated)
28
Accepted this week, now under review
2

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

273filings, 42 of them generic

By application type

Application typeFilings
Supplement127
New drug45
Generic42
Import28
Import re-registration22
Unspecified9

By drug type

Drug typeFilings
Chemical drug208
Therapeutic biologic35
TCM19
Prophylactic biologic6
Biologic5

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
1Urapidil Hydrochloride Injection636
2Rivaroxaban Tablets313
3Sodium Hyaluronate Eye Drops2230
4Indobufen Tablets216
5Levetiracetam extended-release tablets210
6Paliperidone Extend-release Tablets212
7苯磺酸左氨氯地平片 · No verified English name2145
8Escitalopram Oxalate Tablets216
9Ketorolac Tromethamine Injection214
10Sodium Valproate Oral Solution111

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

154 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1MUNDIPHARMA GmbH910
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized880
3AstraZeneca UK Limited730
4Novo Nordisk A/S540
5Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized530
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.532
7Janssen Research & Development LLC440
8Hainan Hong Xiang Qi Rong Pharmaceuticals Technology Co., Ltd. romanized440
9F. Hoffmann-La Roche Ltd420
10Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized420

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

71 this week

AcceptedDrugApplicants
2022/07/07Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSL2200113 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/07Import · Class 2.2 萨特利珠单抗注射液 · No verified English nameJXSL2200112 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/07Import · Class 1 Modakafusp Alfa注射液(TAK-573) · No verified English nameJXSL2200111 Takeda Development Center Americas Inc.; Takeda(China) International Trading Co. Ltd
2022/07/07Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2200110 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2022/07/07Import · Class 1 MK-4830注射液 · No verified English nameJXSL2200109 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/07/07Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2201030 Chongqing Zhong Chuang Ke Pharmaceuticals Co., Ltd. romanized; Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2022/07/07Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2201029 Chongqing Zhong Chuang Ke Pharmaceuticals Co., Ltd. romanized; Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
2022/07/07Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2201025 Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized
2022/07/07New drug · Class 1.2 重组水痘疫苗(CHO细胞) · No verified English nameCXSL2200314 Beijing Lv Zhu Bio Technology Co., Ltd. romanized
2022/07/07New drug · Class 1 GB5005嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200313 Shanghai Ji Bei Bio Technology Co., Ltd. romanized
2022/07/07New drug · Class 1 BGC1201片 · No verified English nameCXHL2200490 Gan Jiang Xin Qu Bo Rui Innovation Pharmaceuticals Co., Ltd. romanized
2022/07/07New drug · Class 1 RG002片 · No verified English nameCXHL2200489 Shanghai Ling Ji Bio Technology Co., Ltd. romanized; Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized
2022/07/07New drug · Class 1 RG002片 · No verified English nameCXHL2200488 Shanghai Ling Ji Bio Technology Co., Ltd. romanized; Shanghai Ling Da Biopharmaceuticals Co., Ltd. romanized
2022/07/07New drug · Class 1 BT-114143注射液 · No verified English nameCXHL2200487 Sai Nuo Ha Bo Pharma (Chengdu) Co., Ltd. romanized
2022/07/06Import · Class 2.2 Efgartigimod浓缩注射液 · No verified English nameJXSL2200103 argenx BV; Zai Lab (Shanghai) Co. Ltd.
2022/07/06Generic · Class 3 Nicorandil for InjectionCYHS2201022 Suzhou Te Rui Pharma Co., Ltd. romanized; Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized
2022/07/06Generic · Class 3 利伐沙班颗粒 · No verified English nameCYHS2200991 Jiangxi Shimei Pharmaceutical Co., Ltd
2022/07/06New drug · Class 1 伊立珠单抗注射液 · No verified English nameCXSL2200311 Bai Tai Bio Pharma Co., Ltd. romanized
2022/07/06New drug · Class 1 PA3670片 · No verified English nameCXHL2200486 Zhejiang Bai La A Tu Pharmaceuticals Technology Co., Ltd. romanized
2022/07/06New drug · Class 1 ICP-248片 · No verified English nameCXHL2200485 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2022/07/06New drug · Class 1 ICP-248片 · No verified English nameCXHL2200484 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2022/07/06New drug · Class 1 ICP-248片 · No verified English nameCXHL2200483 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2022/07/05Import · Class 1 RO6868847薄膜包衣片 · No verified English nameJXHL2200174 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/05Import · Class 1 RO6868847薄膜包衣片 · No verified English nameJXHL2200173 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2022/07/05Import · Class 2.2 TAR-200 · No verified English nameJXHL2200170 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2022/07/05Generic · Class 3 Indobufen TabletsCYHS2201013 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/07/05Generic · Class 3 Indobufen TabletsCYHS2201012 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/07/05Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2201004 Guangxi Jia Jin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/07/05New 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 nameCXSL2200309 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2022/07/05New 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 nameCXSL2200308 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized

41 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.