YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 319 drug applications between 21 September 2023 and 27 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 58 drug names.
2023/09/21 – 2023/09/27
- New acceptances this week
- 319
- Drugs with new generic filings (by drug name, de-duplicated)
- 58
- Accepted this week, now under review
- 3
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
319filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 162 |
| Generic | 76 |
| New drug | 59 |
| Import | 14 |
| Unspecified | 5 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 225 |
| TCM | 52 |
| Therapeutic biologic | 38 |
| Biologic | 2 |
| In vitro diagnostic reagent | 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
58 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Minoxidil Liniment | 6 | 1 | 52 |
| 2 | Sodium Hyaluronate Eye Drops | 3 | 2 | 30 |
| 3 | Tapentadol Hydrochloride Tablets | 3 | 1 | 0 |
| 4 | Methocarbamol Injection | 2 | 2 | 3 |
| 5 | Digoxin Injection | 2 | 1 | 3 |
| 6 | Oxcarbazepine Tablets | 2 | 1 | 4 |
| 7 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 8 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
| 9 | Pregabalin Capsules | 2 | 1 | 12 |
| 10 | 生理氯化钠溶液 · No verified English name | 2 | 1 | 17 |
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 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 10 | 4 | 0 |
| 2 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 4 | Shen Wei Pharma Group Co., Ltd. romanized | 7 | 4 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 6 | Boehringer Ingelheim International GmbH | 6 | 1 | 0 |
| 7 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 6 |
| 8 | Novartis Europharm Limited | 5 | 3 | 0 |
| 9 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 5 | 2 | 0 |
| 10 | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 4 | 4 | 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
102 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/27Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302613 | Jiangsu Jia You Pharma Group Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300085 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300084 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300083 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300082 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300081 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300080 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300079 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300078 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | RJMty19注射液 · No verified English nameCXSL2300661 | Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | GC012F注射液 · No verified English nameCXSL2300660 | Suzhou Gen Xi Bio Technology Co., Ltd. romanized; Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | HGI-001注射液 · No verified English nameCXSL2300659 | Shenzhen Shi He Mu Ji Yin Bio Technology Co., Ltd. romanized |
| 2023/09/27New drug · Class 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2300658 | Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized |
| 2023/09/27New drug · Class 2.4 | 脯氨酸恒格列净片 · No verified English nameCXHS2300090 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/27New drug · Class 2.4 | 脯氨酸恒格列净片 · No verified English nameCXHS2300089 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 注射用JMKX003801 · No verified English nameCXHL2301037 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/09/26Generic · Class 3 | Minoxidil LinimentCYHS2302604 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/09/26Generic · Class 3 | Minoxidil LinimentCYHS2302602 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/09/26Generic · Class 3 | Minoxidil LinimentCYHS2302601 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/09/26Generic · Class 3 | Minoxidil LinimentCYHS2302600 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/09/26Generic · Class 3 | Minoxidil LinimentCYHS2302599 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/09/26Generic · Class 3 | Minoxidil LinimentCYHS2302598 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/09/26Generic · Class 3 | 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2302597 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/09/26Generic · Class 3 | Diprophylline InjectionCYHS2302596 | Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2023/09/26Generic · Class 3 | 萘普生钠软胶囊 · No verified English nameCYHS2302595 | Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized |
| 2023/09/26Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2302594 | Beijing Hai Yi Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2023/09/26Generic · Class 3 | Doxofylline TabletsCYHS2302593 | Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized |
| 2023/09/26Generic · Class 3 | Pregabalin Oral SolutionCYHS2302592 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2023/09/26New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2300657 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2023/09/26New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2300656 | Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized |
72 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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