YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 279 drug applications between 10 June 2023 and 16 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 47 drug names.
2023/06/10 – 2023/06/16
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- Accepted this week, now under review
- 1
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
279filings, 62 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| Generic | 62 |
| New drug | 49 |
| Import | 19 |
| Unspecified | 15 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 198 |
| TCM | 42 |
| Therapeutic biologic | 31 |
| Biologic | 4 |
| Prophylactic biologic | 4 |
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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ethyl Iosapentate Capsules | 2 | 2 | 27 |
| 2 | Empagliflozin Tablets | 2 | 2 | 18 |
| 3 | Methocarbamol Injection | 2 | 2 | 3 |
| 4 | ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name | 2 | 1 | 0 |
| 5 | Furosemide Injection | 2 | 1 | 6 |
| 6 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 7 | Levocarnitine Injection | 2 | 1 | 4 |
| 8 | Potassium Chloride Granules | 2 | 1 | 4 |
| 9 | Procaterol Hydrochloride Oral Solution | 2 | 1 | 12 |
| 10 | Perospirone Hydrochloride Tablets | 2 | 1 | 5 |
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
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen Research & Development LLC | 5 | 5 | 0 |
| 2 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 4 | 5 |
| 5 | Xin Dong Sheng Ji Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Zhejiang Ya Tai Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Guangdong Luo Fu Shan Ge Hong Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized | 3 | 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
93 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/06/16Import · Class 1 | MEDI5752 · No verified English nameJXSL2300110 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2023/06/16Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2300109 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/06/16Import · Class 2.3 | Guselkumab/Golimumab(JNJ-78934804)注射液 · No verified English nameJXSL2300108 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/06/16Import · Class 2.2 | 戈利木单抗注射液 · No verified English nameJXSL2300107 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/06/16Import · Class 1 | LOXO-783片 · No verified English nameJXHL2300143 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/06/16Import · Class 1 | LOXO-783片 · No verified English nameJXHL2300142 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2023/06/16Import · Class 1 | RO7435846片 · No verified English nameJXHL2300141 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/06/16Import · Class 1 | RO7435846片 · No verified English nameJXHL2300140 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/06/16Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301644 | Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized |
| 2023/06/16Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301643 | Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized |
| 2023/06/16Generic · Class 3 | Diprophylline InjectionCYHS2301642 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2023/06/16Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2301639 | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/06/16Generic · Class 3 | Furosemide Oral SolutionCYHS2301638 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/06/16Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2301636 | Guangdong Wen Jian Pharma Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2023/06/16Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2301635 | Guangdong Wen Jian Pharma Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2023/06/16New drug · Class 1 | UBT251注射液 · No verified English nameCXHL2300655 | Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized |
| 2023/06/16New drug · Class 2.2; 2.4 | DA001滴眼液 · No verified English nameCXHL2300654 | Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized |
| 2023/06/16New drug · Class 2.2; 2.4 | DA001滴眼液 · No verified English nameCXHL2300653 | Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized |
| 2023/06/16New drug · Class 2.2; 2.4 | DA001滴眼液 · No verified English nameCXHL2300652 | Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized |
| 2023/06/16New drug · Class 2.2 | 异福酰胺分散片 · No verified English nameCXHL2300651 | Zhejiang Su Ke An Pharma Co., Ltd. romanized |
| 2023/06/15Import · Class 1 | Obefazimod · No verified English nameJXHL2300139 | ABIVAX S.A.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2023/06/15Import · Class 1 | Obefazimod · No verified English nameJXHL2300138 | ABIVAX S.A.; IQVIA RDS (Shanghai) Co. Ltd. |
| 2023/06/15Generic · Class 3 | Sodium Nitroprusside InjectionCYHS2301634 | Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized |
| 2023/06/15Generic · Class 3 | Methocarbamol InjectionCYHS2301627 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.3 | 百令胶囊 · No verified English nameCXZL2300041 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2023/06/15New drug · Class 1 | 注射用DB-1311 · No verified English nameCXSL2300418 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2023/06/15New drug · Class 1 | CUD002注射液 · No verified English nameCXSL2300417 | Sichuan Kang De Sai Medical Technology Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | 水合氯醛口服溶液 · No verified English nameCXHS2300054 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | 水合氯醛口服溶液 · No verified English nameCXHS2300053 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2023/06/15New drug · Class 2.2 | MTS008缓释片 · No verified English nameCXHL2300650 | Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized |
63 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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