YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 435 drug applications between 31 December 2022 and 6 January 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 49 drug names.
2022/12/31 – 2023/01/06
- New acceptances this week
- 435
- Drugs with new generic filings (by drug name, de-duplicated)
- 49
- 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
435filings, 65 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 261 |
| Generic | 65 |
| New drug | 64 |
| Import | 23 |
| Import re-registration | 16 |
| Unspecified | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 274 |
| TCM | 100 |
| Therapeutic biologic | 55 |
| Prophylactic biologic | 5 |
| Biologic | 1 |
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
49 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Penicillin G Sodium For Injection | 3 | 1 | 2 |
| 2 | Dopamine Hydrochloride Injection | 3 | 1 | 3 |
| 3 | Ritonavir Tablets | 2 | 2 | 0 |
| 4 | Famotidine Injection | 2 | 2 | 8 |
| 5 | Phloroglucinol Injection | 2 | 2 | 2 |
| 6 | Perampanel Tablets | 2 | 1 | 2 |
| 7 | Fesoterodine Fumarate Prolonged-Release Tablets | 2 | 1 | 0 |
| 8 | Empagliflozin Tablets | 2 | 1 | 18 |
| 9 | Torasemide Tablets | 2 | 1 | 0 |
| 10 | Lacosamide Injection | 2 | 1 | 0 |
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
205 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guangxi Wei Wei Pharmaceutical Co., Ltd. romanized | 44 | 44 | 0 |
| 2 | Hubei Lang De Pharma Co., Ltd. romanized | 32 | 16 | 0 |
| 3 | Guo Da (Heilongjiang) Pharmaceutical Technology Co., Ltd. romanized | 24 | 24 | 0 |
| 4 | Jiangxi Xin Zheng Pharma Co., Ltd. romanized | 12 | 11 | 0 |
| 5 | Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized | 9 | 6 | 0 |
| 6 | Novo Nordisk A/S | 6 | 2 | 0 |
| 7 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 8 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 5 | 5 | 2 |
| 9 | Novartis Pharma Schweiz AG | 5 | 3 | 0 |
| 10 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized | 5 | 3 | 0 |
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
114 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/01/06Import · Class 1 | Ziltivekimab 注射液 · No verified English nameJXSL2300017 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd |
| 2023/01/06Import · Class 1 | MK-3475A注射液 · No verified English nameJXSL2300016 | Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2023/01/06Import · Class 1 | Bemarituzumab注射液 · No verified English nameJXSL2300015 | Amgen Inc.; Zai Lab (Shanghai) CO. Ltd. |
| 2023/01/06Import · Class 1 | BIIB059 · No verified English nameJXSL2300014 | Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd |
| 2023/01/06Import · Class 2.2 | 司美格鲁肽注射液 · No verified English nameJXSL2300013 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/01/06Import · Class 2.2 | 司美格鲁肽注射液 · No verified English nameJXSL2300012 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/01/06Import · Class 2.2 | 司美格鲁肽注射液 · No verified English nameJXSL2300011 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/01/06Import · Class 2.2 | 司美格鲁肽注射液 · No verified English nameJXSL2300010 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/01/06Import · Class 2.2 | 司美格鲁肽注射液 · No verified English nameJXSL2300009 | Novo Nordisk A/S; Novo Nordisk(China)Pharmaceuticals Co. Ltd. |
| 2023/01/06Import · Class 1 | 帕萨利司片 · No verified English nameJXHS2300004 | Incyte Corporation; Quotient Sciences Philadephia LLC; Innovent Biologics (Suzhou) Co. Ltd |
| 2023/01/06Import · Class 1 | 帕萨利司片 · No verified English nameJXHS2300003 | Incyte Corporation; Quotient Sciences Philadephia LLC; Innovent Biologics (Suzhou) Co. Ltd |
| 2023/01/06Import · Class 1 | 帕萨利司片 · No verified English nameJXHS2300002 | Incyte Corporation; Quotient Sciences Philadephia LLC; Innovent Biologics (Suzhou) Co. Ltd |
| 2023/01/06Generic · Class 3 | Calcium Gluconate InjectionCYHS2300045 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/01/06Generic · Class 3 | Calcium Gluconate in Sodium Chloride InjectionCYHS2300044 | Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2023/01/06Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2300040 | Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Bai Zheng Pharma Co., Ltd. romanized |
| 2023/01/06Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2300039 | Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Bai Zheng Pharma Co., Ltd. romanized |
| 2023/01/06Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2300038 | Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Bai Zheng Pharma Co., Ltd. romanized |
| 2023/01/06Generic · Class 3 | Citicoline Sodium InjectionCYHS2300036 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2023/01/06Generic · Class 3 | Citicoline Sodium InjectionCYHS2300035 | Shanxi De Yuan Tang Pharma Co., Ltd. romanized |
| 2023/01/06Generic · Class 3 | Indobufen TabletsCYHS2300034 | Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized |
| 2023/01/06New drug · Class 2.2 | 注射用维迪西妥单抗 · No verified English nameCXSL2300017 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/01/06New drug · Class 1 | QX007N注射液 · No verified English nameCXSL2300016 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2023/01/06New drug · Class 3.3 | 艾美赛珠单抗注射液 · No verified English nameCXSL2300015 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2023/01/06New drug · Class 1 | IMM27M注射液 · No verified English nameCXSL2300014 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2023/01/06New drug · Class 1 | GC301腺相关病毒注射液 · No verified English nameCXSL2300013 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2023/01/06New drug · Class 1 | FB1001重组人源化单克隆抗体注射液 · No verified English nameCXSL2300012 | Fu Bei Bio Technology (Suzhou) Co., Ltd. romanized |
| 2023/01/06New drug · Class 3.4 | 治疗用卡介苗 · No verified English nameCXSL2300011 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2023/01/06New drug · Class 3.2 | ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2300010 | Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized |
| 2023/01/06New drug · Class 1 | 注射用RC88 · No verified English nameCXSL2300009 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2023/01/06New drug · Class 3.2 | 注射用A型肉毒毒素 · No verified English nameCXSL2300008 | Lanzhou Bio Technology Kai Fa Co., Ltd. romanized |
84 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.