YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 219 drug applications between 18 March 2022 and 24 March 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 20 drug names.
2022/03/18 – 2022/03/24
- New acceptances this week
- 219
- Drugs with new generic filings (by drug name, de-duplicated)
- 20
- 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
219filings, 25 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 133 |
| New drug | 35 |
| Generic | 25 |
| Import | 15 |
| Unspecified | 7 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 147 |
| Therapeutic biologic | 42 |
| TCM | 21 |
| Prophylactic biologic | 7 |
| Biologic | 2 |
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
20 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 2 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
| 3 | Exenatide Injection | 2 | 1 | 0 |
| 4 | Calcium Gluconate Injection | 2 | 1 | 5 |
| 5 | 重酒石酸卡巴拉汀胶囊 · No verified English name | 2 | 1 | 4 |
| 6 | 二硫化硒洗剂 · No verified English name | 1 | 1 | 14 |
| 7 | Lidocaine and Prilocaine Cream | 1 | 1 | 24 |
| 8 | Levofloxacin Tablets | 1 | 1 | 7 |
| 9 | 布南色林片 · No verified English name | 1 | 1 | 0 |
| 10 | Peramivir Injection | 1 | 1 | 7 |
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
122 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized | 9 | 8 | 0 |
| 2 | Zhejiang Dou Bang Pharma Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | AstraZeneca AB | 5 | 2 | 0 |
| 4 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 1 | 0 |
| 5 | Janssen Research & Development LLC | 4 | 4 | 0 |
| 6 | Guo Jiu Tang Shandong E Jiao Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Beijing Rui Ye Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized | 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
59 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/03/24Import · Class 1 | Olvi-Vec注射液 · No verified English nameJXSL2200039 | Genelux Corporation; Newsoara Biopharma Co. Ltd. |
| 2022/03/24Import · Class 2.2 | Faricimab注射液 · No verified English nameJXSL2200038 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/03/24Import · Class 1 | Linzagolix片 · No verified English nameJXHL2200069 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/03/24Import · Class 1 | Linzagolix片 · No verified English nameJXHL2200068 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/03/24Import · Class 1 | Linzagolix片 · No verified English nameJXHL2200067 | Kissei Pharmaceutical Co. Ltd.; Bio Genuine (Shanghai) Biotech Co. Ltd. |
| 2022/03/24New drug · Class 3.4 | 马破伤风免疫球蛋白F(ab′)2 · No verified English nameCXSS2200031 | Yu Xi Jiu Zhou Bio Technology Co., Ltd. romanized |
| 2022/03/24New drug · Class 1 | 注射用LM-108 · No verified English nameCXSL2200143 | Shanghai Li Xin Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2022/03/24New drug · Class 1 | ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2200142 | Hua Xia Yuan (Shanghai) Bio Technology Co., Ltd. romanized |
| 2022/03/24New drug · Class 1 | 抗CD19/CD20嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2200141 | Shanghai Sai Bi Man Bio Technology Co., Ltd. romanized |
| 2022/03/24New drug · Class 2.2 | 小儿水合氯醛糖浆 · No verified English nameCXHS2200017 | Hainan Peng Kang Pharma Co., Ltd. romanized; Hainan Sen Qi Pharmaceutical Co., Ltd. romanized |
| 2022/03/24New drug · Class 1 | MN-08眼用凝胶 · No verified English nameCXHL2200184 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2022/03/24New drug · Class 1 | MN-08眼用凝胶 · No verified English nameCXHL2200183 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2022/03/24New drug · Class 1 | MN-08眼用凝胶 · No verified English nameCXHL2200182 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2022/03/24New drug · Class 1 | MN-08眼用凝胶 · No verified English nameCXHL2200181 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2022/03/24New drug · Class 2.3 | Y-6舌下片 · No verified English nameCXHL2200178 | Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized |
| 2022/03/23New drug · Class 1 | AK104注射液 · No verified English nameCXSL2200140 | Kang Fang Pharma Co., Ltd. romanized |
| 2022/03/23New drug · Class 1 | RP903片 · No verified English nameCXHL2200180 | Jun Shi Run Jia (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/03/23New drug · Class 1 | RP903片 · No verified English nameCXHL2200179 | Jun Shi Run Jia (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/03/23New drug · Class 1 | MY004567片 · No verified English nameCXHL2200177 | Shanghai Mei Yue Bio Technology Development Co., Ltd. romanized |
| 2022/03/23New drug · Class 1 | MY004567片 · No verified English nameCXHL2200176 | Shanghai Mei Yue Bio Technology Development Co., Ltd. romanized |
| 2022/03/23New drug · Class 1 | INS018_055胶囊 · No verified English nameCXHL2200175 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2022/03/23New drug · Class 1 | INS018_055胶囊 · No verified English nameCXHL2200174 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2022/03/23New drug · Class 1 | INS018_055胶囊 · No verified English nameCXHL2200173 | Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized |
| 2022/03/22Import · Class 1.1 | 九价肠外致病性大肠埃希菌疫苗 · No verified English nameJXSL2200037 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/03/22Import · Class 1 | Depemokimab注射液 · No verified English nameJXSL2200036 | GlaxoSmithKline (Ireland) Limited; GlaxoSmithKline(China) Investment Co. Ltd |
| 2022/03/22Import · Class 2.3 | Guselkumab/Golimumab(JNJ-78934804)注射液 · No verified English nameJXSL2200035 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/03/22Import · Class 2.2 | 戈利木单抗注射液 · No verified English nameJXSL2200034 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/03/22Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2200033 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/03/22Import · Class 2.4 | 赛沃替尼片 · No verified English nameJXHL2200064 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2022/03/22Import · Class 2.4 | 赛沃替尼片 · No verified English nameJXHL2200063 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
29 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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