YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 331 drug applications between 1 November 2023 and 7 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 80, covering 59 drug names.
2023/11/01 – 2023/11/07
- New acceptances this week
- 331
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- 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
331filings, 80 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 80 |
| New drug | 61 |
| Import re-registration | 12 |
| Import | 7 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 208 |
| TCM | 82 |
| Therapeutic biologic | 39 |
| Biologic | 1 |
| Prophylactic 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | Potassium Chloride Granules | 4 | 2 | 4 |
| 3 | Minoxidil Liniment | 3 | 2 | 52 |
| 4 | 中/长链脂肪乳注射液(C6~24) · No verified English name | 3 | 1 | 0 |
| 5 | Perindopril tert-Butylamine Tablets | 3 | 1 | 5 |
| 6 | Potassium Phosphates Injection | 2 | 2 | 2 |
| 7 | Potassium Chloride Injection | 2 | 2 | 10 |
| 8 | Carbazochrome Sodium Sulfonate Injection | 2 | 1 | 1 |
| 9 | Orlistat Capsules | 2 | 1 | 8 |
| 10 | Olmesartan Medoxomil Tablets | 2 | 1 | 1 |
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
198 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 19 | 19 | 0 |
| 2 | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 3 | Guangdong Tuan Li Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Janssen-Cilag International NV | 5 | 2 | 0 |
| 5 | Merck Sharp & Dohme B.V. | 5 | 1 | 0 |
| 6 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 2 | 4 |
| 8 | Wuhan Lang Lai Technology Development Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | AstraZeneca AB | 4 | 1 | 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
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/11/07Import · Class 1 | AZD5305 · No verified English nameJXHL2300275 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/11/07Import · Class 1 | AZD5305 · No verified English nameJXHL2300274 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/11/07Import · Class 1 | AZD5305 · No verified English nameJXHL2300273 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/11/07Import · Class 1 | AZD5305 · No verified English nameJXHL2300272 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2023/11/07Generic · Class 3 | Folic Acid TabletsCYHS2303033 | Shenyang Tian Bang Pharma Co., Ltd. romanized |
| 2023/11/07Generic · Class 3 | Potassium Chloride GranulesCYHS2303029 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized |
| 2023/11/07Generic · Class 3 | Potassium Chloride GranulesCYHS2303028 | Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Guo Run Pharmaceutical Co., Ltd. romanized |
| 2023/11/07Generic · Class 3 | Desonide OintmentCYHS2303027 | Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/07Generic · Class 3 | 米诺地尔泡沫剂 · No verified English nameCYHS2303026 | Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized; Ji Ning Wei Min Pharmaceutical Co., Ltd. romanized |
| 2023/11/07Generic · Class 3 | Famotidine InjectionCYHS2303025 | Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized |
| 2023/11/07Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2303024 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2023/11/07Generic · Class 3 | Naproxen Sodium TabletsCYHS2303023 | Changchun Hai Yue Pharma Co., Ltd. romanized |
| 2023/11/07Generic · Class 3 | Potassium Chloride InjectionCYHS2303022 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/11/07New drug · Class 1 | AZD0901 · No verified English nameCXSL2300767 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/11/07New drug · Class 1 | 注射用SHR-A1921 · No verified English nameCXSL2300766 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2023/11/07New drug · Class 1 | AZD0901 · No verified English nameCXSL2300765 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2023/11/07New drug · Class 1 | 注射用JMKX003142 · No verified English nameCXHL2301229 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/11/07New drug · Class 1 | ND-003片 · No verified English nameCXHL2301228 | Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized |
| 2023/11/07New drug · Class 1 | ND-003片 · No verified English nameCXHL2301227 | Shenzhen Shi Xin Yue Bio Technology Co., Ltd. romanized; Shenzhen Shi Xiao Fen Zi Xin Yao Innovation Center Co., Ltd. romanized |
| 2023/11/07New drug · Class 2.2 | 阿哌沙班胃滞留缓释胶囊 · No verified English nameCXHL2301226 | Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/07New drug · Class 1 | ABP1019A片 · No verified English nameCXHL2301225 | Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/07New drug · Class 1 | ABP1019A片 · No verified English nameCXHL2301224 | Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/11/06Generic · Class 3 | Potassium Phosphates InjectionCYHS2303010 | Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/11/06New drug · Class 1 | QR056240CR片 · No verified English nameCXHL2301223 | Wuhan Lang Lai Technology Development Co., Ltd. romanized |
| 2023/11/06New drug · Class 1 | QR056240CR片 · No verified English nameCXHL2301222 | Wuhan Lang Lai Technology Development Co., Ltd. romanized |
| 2023/11/06New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2301221 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/11/06New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2301220 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/11/06New drug · Class 1 | BGB-43395片 · No verified English nameCXHL2301219 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/11/04Generic · Class 3 | Potassium Phosphates InjectionCYHS2303008 | Chengdu Giantech Hi-technology Development Co., Ltd.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/11/04Generic · Class 3 | 富马酸酮替芬滴眼液 · No verified English nameCYHS2303005 | Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
71 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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