YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 205 drug applications between 21 July 2021 and 27 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 24 drug names.
2021/07/21 – 2021/07/27
- New acceptances this week
- 205
- Drugs with new generic filings (by drug name, de-duplicated)
- 24
- 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
205filings, 32 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 113 |
| New drug | 35 |
| Generic | 32 |
| Import | 17 |
| Unspecified | 5 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 131 |
| Therapeutic biologic | 42 |
| TCM | 21 |
| Prophylactic biologic | 9 |
| 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
24 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Neostigmine Methylsulfate Injection | 3 | 1 | 4 |
| 2 | Carbetocin Injection | 2 | 2 | 6 |
| 3 | Pregabalin Capsules | 2 | 1 | 12 |
| 4 | Micafungin Sodium for Injection | 2 | 1 | 0 |
| 5 | Iodixanol Injection | 2 | 1 | 0 |
| 6 | Eldecalcitol Soft Capsules | 2 | 1 | 8 |
| 7 | Dapagliflozin Tablets | 2 | 1 | 84 |
| 8 | Enoxaparin Sodium Injection | 1 | 1 | 16 |
| 9 | Limaprost Alfadex Tablets | 1 | 1 | 0 |
| 10 | Tenofovir alafenamide Fumarate Tablets | 1 | 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
132 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 2 | Janssen-Cilag International NV | 5 | 4 | 0 |
| 3 | SANOFI PASTEUR | 4 | 2 | 0 |
| 4 | Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized | 4 | 2 | 0 |
| 5 | Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Xian Tang Chen Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Novo Nordisk A/S | 3 | 2 | 0 |
| 9 | Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized | 3 | 2 | 0 |
| 10 | Pfizer Europe MA EEIG | 3 | 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
56 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/07/27Import · Class 3.1 | 耐多种抗生素克劳氏芽孢杆菌芽孢口服混悬剂 · No verified English nameJXSL2101078 | Sanofi S.r.l.; Sanofi (China) Investment Co. Ltd. |
| 2021/07/27Import · Class 1 | Epcoritamab注射用浓溶液 · No verified English nameJXSL2101077 | Genmab US Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2021/07/27Import · Class 1 | Epcoritamab注射液 · No verified English nameJXSL2101076 | Genmab US Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2021/07/27Import · Class 1 | Epcoritamab注射用浓溶液 · No verified English nameJXSL2101075 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2021/07/27Import · Class 1 | Epcoritamab注射液 · No verified English nameJXSL2101074 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2021/07/27Import · Class 1 | ABL001片 · No verified English nameJXHL2101141 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/07/27New drug · Class 1.1 | 艾拉片 · No verified English nameCXZL2101020 | Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized |
| 2021/07/27New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2101219 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101218 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/27New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSL2101217 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | SHR0302片 · No verified English nameCXHL2101331 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | SHR0302片 · No verified English nameCXHL2101330 | Rui Shi Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | OT202滴眼液 · No verified English nameCXHL2101326 | Ou Kang Wei Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | OT202滴眼液 · No verified English nameCXHL2101325 | Ou Kang Wei Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | OT202滴眼液 · No verified English nameCXHL2101324 | Ou Kang Wei Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | HMPL-760胶囊 · No verified English nameCXHL2101320 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | HMPL-760胶囊 · No verified English nameCXHL2101319 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | HMPL-760胶囊 · No verified English nameCXHL2101318 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2021/07/27New drug · Class 1 | ACT001胶囊 · No verified English nameCXHL2101311 | Xin Yi Shang De Yao Yuan Pharma Co., Ltd. romanized |
| 2021/07/26Import · Class 1 | RO7030816 · No verified English nameJXSL2101073 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/07/26Import · Class 1 | RO7030816 · No verified English nameJXSL2101072 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/07/26Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2101071 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2021/07/26Import · Class 1 | PF-06823859注射液 · No verified English nameJXSL2101070 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2021/07/26Import · Class 2.4 | Lazertinib片 · No verified English nameJXHL2101140 | Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd. |
| 2021/07/26Generic · Class 3 | Limaprost Alfadex TabletsCYHS2101475 | Beijing Tai De Pharmaceutical Co., Ltd. romanized |
| 2021/07/26New drug · Class 1 | QX006N注射液 · No verified English nameCXSL2101214 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2021/07/26New drug · Class 1 | 注射用BC3448 · No verified English nameCXSL2101213 | Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized |
| 2021/07/26New drug · Class 2.4 | 硝羟喹啉片 · No verified English nameCXHL2101329 | Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/07/26New drug · Class 1 | 注射用TB001 · No verified English nameCXHL2101328 | Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
| 2021/07/26New drug · Class 1 | 注射用TB001 · No verified English nameCXHL2101327 | Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized |
26 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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