YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 278 drug applications between 15 June 2024 and 21 June 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 52 drug names.

2024/06/15 – 2024/06/21

Period
2024/06/15 to 2024/06/21, 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
278
Drugs with new generic filings (by drug name, de-duplicated)
52
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

278filings, 72 of them generic

By application type

Application typeFilings
Supplement134
Generic72
New drug37
Import16
Unspecified9
Import re-registration8
Drug-device combination product2

By drug type

Drug typeFilings
Chemical drug166
TCM53
Therapeutic biologic45
Prophylactic biologic10
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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levocarnitine Oral Solution339
2Sodium Ibandronate Injection314
3Brivaracetam Tablets3119
4Penicillin G Sodium For Injection312
5Polidocanol Injection3123
6Deoxycholic Acid Injection220
7Bisoprolol Fumarate and Amlodipine Besylate Tablets229
8Glucosamine Sulfate Capsules2251
9Sitagliptin and Metformin Hydrochloride Extended-release Tablets2212
10Lactulose Oral Solution2134

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

185 companies with new acceptances; top 10 listed

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

82 this week

AcceptedDrugApplicants
2024/06/21Import · Class 3.1 注射用坦昔妥单抗 · No verified English nameJXSS2400050 Incyte Biosciences Distribution B.V.; Baxter Oncology GmbH; Beijing InnoCare Pharma Tech Co. Ltd.
2024/06/21Import · Class 3.1 司库奇尤单抗注射液 · No verified English nameJXSS2400049 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Novartis Pharmaceutical Manufacturing GmbH
2024/06/21Import · Class 3.1 司库奇尤单抗注射液 · No verified English nameJXSS2400048 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG
2024/06/21Import · Class 2.2 贝利尤单抗注射液(皮下注射) · No verified English nameJXSL2400116 GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline (China) Investment Company Limited
2024/06/21Import · Class 2.4 Osimertinib Mesylate TabletsJXHS2400042 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/06/21Import · Class 2.4 Osimertinib Mesylate TabletsJXHS2400041 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2024/06/21Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2401853 Zhejiang Jiang Bei Pharma Co., Ltd. romanized
2024/06/21Generic · Class 3 Penicillin G Sodium For InjectionCYHS2401852 Liaoning Sheng Lian Ke Pharma Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized
2024/06/21Generic · Class 3 Penicillin G Sodium For InjectionCYHS2401851 Liaoning Sheng Lian Ke Pharma Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized
2024/06/21Generic · Class 3 Penicillin G Sodium For InjectionCYHS2401850 Liaoning Sheng Lian Ke Pharma Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanized
2024/06/21Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2401849 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2024/06/21Generic · Class 3 Fosfomycin Sodium For InjectionCYHS2401848 Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized; Guo Yao Group Guo Rui Pharma Co., Ltd. romanized
2024/06/21Generic · Class 3 盐酸米诺环素泡沫剂 · No verified English nameCYHL2400123 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2024/06/21Generic · Class 3 盐酸米诺环素泡沫剂 · No verified English nameCYHL2400122 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2024/06/21Generic · Class 3 Deoxycholic Acid InjectionCYHL2400121 Beijing Cang Wei Xin Kang Pharmaceuticals Research and Development Co., Ltd. romanized
2024/06/21Generic · Class 3 立他司特滴眼液 · No verified English nameCYHL2400120 Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2024/06/21Generic · Class 3 氟[18F]妥司特注射液 · No verified English nameCYHL2400119 Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized
2024/06/21New drug · Class 1 注射用HS-20089 · No verified English nameCXSL2400407 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/06/21New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2400406 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2024/06/21New drug · Class 1 AK135注射液 · No verified English nameCXSL2400405 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2024/06/21New drug · Class 1 TQB2825注射液 · No verified English nameCXSL2400404 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/06/21New drug · Class 1 TQB2825注射液 · No verified English nameCXSL2400403 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/06/21New drug · Class 1 CS01单抗注射液 · No verified English nameCXSL2400402 Zhong Shan Heng Dong Biopharmaceutical Co., Ltd. romanized
2024/06/21New drug · Class 1 HS-10502片 · No verified English nameCXHL2400620 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/06/21New drug · Class 1 HS-10502片 · No verified English nameCXHL2400619 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2024/06/21New drug · Class 2.2 ZP036 · No verified English nameCXHL2400618 Hua Run Zi Zhu Pharma Co., Ltd. romanized
2024/06/21New drug · Class 1 RG002C0106注射液 · No verified English nameCXHL2400617 Beijing Xuan Jing Rui Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Xuan Jing Bio Technology Co., Ltd. romanized
2024/06/21New drug · Class 1 177Lu-TR0471注射液 · No verified English nameCXHL2400616 Tong Rui Biopharmaceutical (Chengdu) Co., Ltd. romanized
2024/06/21New drug · Class 1 吸入用LH-1901 · No verified English nameCXHL2400615 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Zhongguo Yao Ke University romanized
2024/06/21New drug · Class 1 吸入用LH-1901 · No verified English nameCXHL2400614 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.; Zhongguo Yao Ke University romanized

52 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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